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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):

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.

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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). The Masimo MightySat Rx Fingertip Pulse Oximeter is indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and mobile environments.

The subject device, MightySat Rx, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen arterial hemoglobin (SpO2) and pulse rate in adults and pediatrics. 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 mobiles devices, such as a smartphone.

The mobile device functions as a secondary display and it is not required for the intended use of pulse oximetry measurements. After measurements are made by the subject device, the data can be transferred to the mobile device via Bluetooth for the display and/or storage of the data.

Here's a breakdown of the acceptance criteria and study information for the Masimo MightySat Rx Fingertip Pulse Oximeter, based on the provided document:

Acceptance Criteria and Device Performance

Note: The document also lists acceptance criteria for Pulse Rate (No motion, Motion, Low Perfusion) and SpO2 (Low Perfusion) in the "SPECIFICATION" table on page 5, but the reported clinical testing results only explicitly state the SpO2 accuracy under no motion and motion conditions. It does state that the device "meets the accuracy requirement" for SpO2, implying other parameters were also met (e.g., 2% Arms for SpO2 Low Perfusion), but specific values are not provided for those.

Study Information

2. Sample size used for the test set and the data provenance:

• Sample Size: 14 healthy adult male and female volunteers (with at least a total of 356 blood samples).
• Data Provenance: Not explicitly stated regarding country of origin, but it's a clinical study conducted. The study is prospective as it describes the validation of the SpO2 measurement "in accordance with ISO 80601-2-61" carried out on human volunteers.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The ground truth was established "against a laboratory CO-Oximeter." This implies the CO-Oximeter itself is the "expert" or standard, not human experts. Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically understood in image-based AI studies does not apply here.

4. Adjudication method for the test set:

• Not applicable/Not explicitly mentioned. The ground truth was established by a laboratory CO-Oximeter, which provides a direct measurement, not an interpretation requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone performance study was done. The clinical testing described validates the accuracy of the device's functional oxygen saturation and pulse rate measurements as performed by the device itself against a laboratory standard, without human intervention in the measurement process after initial placement.

7. The type of ground truth used:

• Ground Truth Type: Laboratory CO-Oximeter measurements of functional oxygen saturation.

8. The sample size for the training set:

• The document does not specify a separate "training set" sample size. This type of device relies on established physiological principles and signal processing, rather than machine learning models that require distinct training and test sets in the same way. The clinical testing described is primarily for validation (test set).

9. How the ground truth for the training set was established:

• Not applicable, as a distinct "training set" with established ground truth as commonly understood in AI/ML contexts is not described for this device. The device's operation is based on its integrated Masimo SET technology and established algorithms for pulse oximetry, which would have been developed and refined through engineering and earlier research, not necessarily through a formal "training set" in the context of this 510(k) submission.

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