(255 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2, No Motion (70-100% range) | 1.66% Arms (Accuracy meets requirement of ≤ 2%) |
| SpO2, Motion (70-100% range) | 2.30% Arms (Accuracy meets requirement of ≤ 3%) |
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.
§ 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).