Masimo Corporation · NASDAQ:MASI
Masimo — Technical Presentation (November 2022)
13 slides from Masimo's technical presentation, November 2022
Slide 1: Masimo SET Pulse Oximetry and Skin Pigmentation
Masimo SET® Pulse Oximetry and Skin Pigmentation Supplemental Slides For professional use. See instructions for use for full prescribing information including indications, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a ph
Slide 2: Background
Background The purpose of the following supplemental slides is to provide additional information on Masimo SET® performance in varying skin pigmentations. © 2022 Masimo. All rights reserved.
Slide 3: Executive Summary
Executive Summary > Masimo invented Measure-through Motion and Low Perfusion™ pulse oximetry using Signal Extraction Technology® (SET®) over three decades ago to address these known pulse oximetry confounders. > SET® also addresses skin pigmentation and other static absorbers such as skin thickness
Slide 4: Racial Effects on Masimo Pulse Oximetry: A Laboratory Study
Racial Effects on Masimo Pulse Oximetry: A Laboratory Study ˃ Barker SJ – Chief Science Officer and Wilson WC – Chief Medical Officer ˃ Retrospective analysis of Masimo SET® data ˃ Abstract presented at Society of Technology in Anesthesiology (STA) Annual Meeting in January 2022 ˃ Full Manuscript in
Slide 5: Study Methods
Study Methods > Data from volunteers October 2015 - July 2021 > Masimo SET® pulse oximeters with RD SET® sensors > Volunteers underwent stepwise hypoxemia, with arterial SaO2 down to 70% > SpO2 values time-matched with ABG samples within 5 seconds tHb MetHb Age CoHb % Masimo Paired Massey (g/dL) % N
Slide 6: Study Participant Skin Color Distribution Histogram
Study Participant Skin Color Distribution Histogram (Massey-Martin Scale by Self-identified Race) Barker, S.J., Wilson, W.C. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput (2022). Available on-line at: https://doi.org/10.1007/s10877-022-00927-w © 2022 Masimo. All ri
Slide 7: SpO2-SaO2 Results: Bias Difference of 0.15% Not Clinically Significant
SpO2-SaO2 Results Bias Difference of 0.15% is NOT Clinically Significant. (n = 3,982) (n = 3,201) Bias = -0.05% Bias = -0.20% ARMS = 1.35% ARMS = 1.42% Barker, S.J., Wilson, W.C. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput (2022). Available on-line at: https://do
Slide 8: Occult Hypoxemia Results: Sjoding vs. Masimo
Occult Hypoxemia Results: Sjoding vs. Masimo (Box Plots in 1% Bins) Occult Hypoxemia Sjoding, et al.1 Masimo RD SET2 1 Sjoding MW, et al. N Engl J Med. 2022;383(25):2477-2478. 2 Barker, S.J., Wilson, W.C. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput (2022). Availa
Slide 9: Study Conclusions
Study Conclusions > The SpO2-SaO2 difference (bias) of 0.15% is not clinically significant because 0.15 is approximately 1/7 of 1% and the SpO2 display resolution on all pulse oximeters is 1%. > There was no clinically significant difference in the accuracy or bias between Black and White subjects m
Slide 10: FDA Advisory Meeting
FDA Advisory Meeting > Masimo applauds the FDA’s decision to convene an Advisory Meeting on Pulse Oximetry on November 1, 2022 to discuss the real-world performance of pulse oximeters and factors impacting accuracy in diverse populations. > The information provided is under consideration by the FDA
Slide 11: Masimo's Call to Action
Masimo’s Call to Action As a key contributor to this panel, Masimo believes that it is in the public interest to implement the following policies for gaining 510(k) clearance of medical-grade pulse oximeters: > More stringent ARMS accuracy requirements. > Greater diversity of skin tones for validati
Slide 12: Conclusion
Conclusion > Masimo is currently pursuing prospective clinical studies to a) confirm our laboratory data showing excellent accuracy across all skin tones and b) continue to improve both accuracy and reliability. > There is abundant evidence that non-medical- grade pulse oximeters are being purchased
Slide 13: Visit www.masimo.com/rd-set-sensors to learn more
Visit www.masimo.com/rd-set-sensors to learn more about RD SET sensors For professional use. See instructions for use for full prescribing information including indications, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a