(762 days)
The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.
The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.
The subject device, MightySat-OTC, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in individuals 18 years and older. The predicate MightySat that was previously cleared under K181956, has the same intended use as the subject device except it is cleared for prescription use only.
The subject device is identical to the predicate with the RRp and PVi parameters have been disabled in the subject device and the labeling has been modified to provide additional information on the role of pulse oximeters for OTC users. There were no hardware changes made to the MightySat Rx (predicate device, K181956) that resulted in the MightySat-OTC. Like the predicate device, the subject device, has the combined function of a pulse oximeter monitor and a reusable sensor. It includes a color display, enclosed by plastic housing, and powered by two alkaline "AAA" batteries. It also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile device application.
Here’s an analysis of the acceptance criteria and study details for the Masimo MightySat-OTC, based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Criterion (Measurement Accuracy in Accordance with ISO 80601-2-61) | Acceptance Limit (ARMS) | Reported Device Performance (ARMS) |
|---|---|---|
| SpO2, No Motion (70 - 100%, 18 years and older) | 1.5% | 1.26% |
| SpO2, Low Perfusion (70 - 100%, 18 years and older) | 2% | 2% (Same as predicate, implied to meet) |
| Pulse Rate, No Motion (25 – 240 BPM, 18 years and older) | 3 BPM | 3 BPM (Same as predicate, implied to meet) |
| Pulse Rate, Low Perfusion (25 – 240 BPM, 18 years and older) | 3 BPM | 3 BPM (Same as predicate, implied to meet) |
| SpO2 across different skin pigments and genders | Within 1.5% | Met across all measured subgroups (Light Male: 1.27%, Dark Male: 1.44%, Light Female: 1.11%, Dark Female: 1.32%) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 39 healthy volunteer subjects.
- Data Provenance: The study was a prospective clinical performance testing conducted in accordance with ISO 80601-2-61. The location of the study is not explicitly stated, but it is a clinical study involving human volunteers. Data includes varying skin pigmentation, measured using the color-based Massey-Martin scale.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth. For pulse oximetry, the ground truth for SpO2 is typically established through arterial blood gas analysis (reference oximeter), usually performed by trained medical professionals, but this detail is not provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (like 2+1, 3+1). For pulse oximetry clinical studies, ground truth is generally obtained directly from standardized reference methods (e.g., CO-oximetry of arterial blood samples), not through expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a reference method for SpO2 and PR accuracy. The document mentions human factors and usability testing to validate user understanding of labeling and device outputs for OTC use, but this is a different type of study than an MRMC comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary clinical performance testing for SpO2 and Pulse Rate accuracy appears to be a standalone (algorithm only) evaluation. The device measures and displays physiological signals directly, and the clinical study evaluates the accuracy of these measurements against a reference standard. The "human factors and usability testing" is a separate evaluation of the user interface and labeling for OTC use, not directly related to the algorithm's diagnostic performance with human input.
7. The Type of Ground Truth Used
The ground truth for SpO2 accuracy is based on a reference standard, specifically arterial blood oxygen saturation (SaO2), as implied by the "SaO2 range" in the performance tables. For pulse oximeters, this typically involves drawing arterial blood samples and analyzing them with a laboratory CO-oximeter.
8. The Sample Size for the Training Set
The document does not provide a specific sample size for the training set. It mentions that "the calibration curve has been adjusted to allow for improved accuracy performance, including across different skin pigments and genders." This implies that data was used to train or refine the device's algorithms, but the size and characteristics of that dataset are not detailed in this submission.
9. How the Ground Truth for the Training Set Was Established
The document states that the calibration curve was "adjusted to allow for improved accuracy performance, including across different skin pigments and genders." While it doesn't describe the exact process for establishing ground truth for this internal adjustment/training, it would typically involve similar methods to the clinical validation: comparing the device's readings to arterial blood gas measurements from a diverse population.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).