Peer-Reviewed Study Finds That Masimo SET® Pulse Oximetry Has No Clinically Significant Difference in Accuracy or Bias Between Black and White People

Masimo (NASDAQ: MASI) today announced the publication of a peer-reviewed study regarding Masimo SET^® pulse oximetry performance in varying skin pigmentation in the Journal of Clinical Monitoring and Computing. The retrospective trial, “Racial effects on Masimo pulse oximetry: a laboratory study,” by Drs. Steven J. Barker and Wilson C. Wilson, found that there was no clinically significant difference in the accuracy or bias between Black and White subjects studied with Masimo SET^® pulse oximetry and Masimo RD SET^® sensors.¹

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Masimo SET® Pulse Oximetry with RD SET® Sensors (Photo: Business Wire)

For this newly published study Dr. Barker (Chief Science Officer, Masimo) and Dr. Wilson (Chief Medical Officer, Masimo) performed a retrospective analysis of Masimo laboratory data obtained from self-identified Black and White volunteer subjects, to evaluate differences in Masimo pulse oximeter accuracy and bias on the basis of skin tone. The investigators reviewed data collected between October 2015 and July 2021, which included 7,183 paired samples (3,201 Black and 3,982 White) collected from 75 subjects (39 Black and 36 White), who were screened with the same criteria to remove potential bias based on health conditions. All subjects were exposed to the same hypoxia protocol, which varied the arterial saturation of hemoglobin (SaO₂) between 70% and 100%. Noninvasive oxygen saturation (SpO₂) values were obtained from Masimo SET^® pulse oximeters with RD SET^® sensors and time-matched with simultaneously taken arterial blood gas (ABG) samples analyzed using an ABL-835 blood gas analyzer.

The data were analyzed to determine the bias (mean difference in paired SpO₂ and SaO₂ samples), precision (standard deviation of the difference), and accuracy (root mean squared error, A_RMS*) for both groups. A negative bias of 0.20% was found for Black subjects, compared to 0.05% for White subjects. This difference of 0.15% (p < 0.001) is not clinically significant and the values are numerically indistinguishable because the SpO₂ display resolution is 1% on commercially available pulse oximeters (both from Masimo and other manufacturers). The investigators also found a precision of 1.40% for Black subjects and 1.35% for White subjects. Accuracy (A_RMS) was 1.42% for Black subjects and 1.35% for White subjects. These results are consistent with the accuracy specifications of RD SET sensors (1.5% accuracy A_RMS), which are twice as good as the current FDA clearance thresholds for medical-grade pulse oximeters (3.0% accuracy A_RMS).

In discussing their findings, Drs. Barker and Wilson describe how Masimo SET^® accounts for skin pigmentation when measuring SpO₂. “The absence of racial bias, and highly accurate overall performance exhibited by Masimo SET^® pulse oximetry can be logically explained by Masimo’s engineering design and testing paradigm. … Conventional pulse oximetry uses the standard red over infrared algorithm to provide SpO₂, while Masimo SET^® uses that conventional algorithm along with four additional signal processing engines that all run in parallel. These signal processing systems allow the distinction between arterial and venous signal during motion and low perfusion by identifying and isolating the non-arterial and venous noise SpO₂ from the true arterial SpO₂ components in the signal. These multiple signal processing engines work together to overcome limitations of each independent method. This advanced technique allows for a more accurate picture of the pulsatile (arterial) signal and significantly reduces the impact of static absorbers such as skin pigment, bone density, and tissue thickness (e.g., finger, toe, or earlobe). Finally, the Masimo SET^® SpO₂ algorithm is calibrated and then validated using nearly equal numbers of dark and light-skinned subjects.”

Drs. Barker and Wilson summarized, “In conclusion, this retrospective study of healthy human volunteers monitored with Masimo RD SET pulse oximeter sensors showed an absence of clinically significant differences in accuracy between Black and White subjects.” The authors suggested that additional prospective clinical studies should be conducted to validate their results in critically ill patients utilizing Masimo SET^® pulse oximeters and those from other manufacturers.

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*A_RMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- A_RMS of the reference measurements in a controlled study.

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius Tº^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Barker SJ, Wilson WC. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput. 12 Nov 2022. https://doi.org/10.1007/s10877-022-00927-w.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET^® and RD SET^®, and Masimo’s plan to conduct additional studies on the accuracy of Masimo SET^® and RD SET on Black people and White people (“Additional Studies”). These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including SET^® and RD SET, contribute to positive clinical outcomes and patient safety; risks that Masimo fails to conduct Additional Studies as planned; risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

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