(184 days)
The Masimo MightySat Rx Fingertip Pulse Oximeter is intended for hospital-type facilities, home environments, and transport.
The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for the noninvasive spot checking of respiration rate (RRp) for adult patients.
The subject device, MightySat Rx, was previously cleared under K150314 as a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpOz), pulse rate (PR), calculation of Perfusion Index (Pi) and optional Pleth Variability Index (PVi) in adults and pediatrics. The current submission concerns the MightySat Rx's measurement of respiration rate through photoplethysmogram analysis (designated as RRp).
Like the secondary predicate (K150314), the device is a spot check pulse oximeter and does not include alarms. The device has the combined function of a pulse oximeter monitor and a reusable sensor. It includes an OLED color display, enclosed by plastic housing and powered by two alkaline AAA batteries.
The MightySat Rx also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices, such as a smartphone.
1. Acceptance Criteria and Reported Device Performance (RRp Measurement):
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| RRp Accuracy (Adults) | 4-70 RPM, 3 RPM ARMS | 4-70 RPM, 3 RPM ARMS |
| RRp Mean Error (Adults) | 1 RPM Mean Error | 1 RPM Mean Error |
2. Sample Size and Data Provenance for Test Set:
- Prospective Study: 28 healthy volunteers. Data provenance is not explicitly stated but implies a controlled clinical setting, likely within the US given the FDA submission.
- Retrospective Study: 59 hospitalized subjects. Data provenance is not explicitly stated but implies a clinical setting, likely within the US.
3. Number and Qualifications of Experts for Ground Truth:
The document states that the RRp measurements were compared against "manual, clinician-scored capnograms." The number of clinicians and their specific qualifications (e.g., years of experience, specialty) are not provided in this document.
4. Adjudication Method for Test Set:
The adjudication method for establishing ground truth is not explicitly stated beyond "manual, clinician-scored capnograms." It does not mention whether multiple clinicians were used or if a specific adjudication process (e.g., 2+1, 3+1) was employed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned for the RRp measurement. The studies described are focused on the standalone performance of the device.
6. Standalone Performance Study:
Yes, a standalone performance study was done for the RRp measurement. Two clinical tests were performed to validate the accuracy:
- A prospective analysis on 28 healthy volunteers.
- A retrospective analysis on 59 hospitalized subjects with different clinical conditions.
7. Type of Ground Truth Used:
The ground truth used for the RRp measurement was "manual, clinician-scored capnograms" obtained from a Capnostream20 device (K060065). This indicates a form of expert consensus based on instrument readings.
8. Sample Size for Training Set:
The document does not explicitly state the sample size used for the training set for the RRp algorithm. It mentions that the technology change for RRp is a "software change which utilizes the same hardware as the secondary predicate," and that "the primary predicate and subject device both rely on the technological principle of respiration-induced variations in the photoplethysmogram." This suggests that the algorithm likely learned from data that exhibits these physiological variations, but the specific training dataset size is not provided.
9. How Ground Truth for Training Set was Established:
The document does not explicitly describe how the ground truth for the training set was established. It notes that "both devices rely on the technological principle of respiration-induced variations in the photoplethysmogram," and references a scientific paper on multiparameter respiratory rate estimation. This implies that the algorithm's development (and thus its training, if applicable) was based on established physiological principles and potentially data where these variations were known or measured by other validated methods. However, the exact method for establishing ground truth for any potential training set is not detailed.
§ 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).