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The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO₂), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.

Here's an analysis of the acceptance criteria and study details for the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories, based on the provided text:

Acceptance Criteria and Device Performance

Note: The reported device performance (clinical results) are presented as "rms" (root mean square) values, which indicate the standard deviation of the accuracy, implying that a smaller RMS value is better and meets the stated ± X% or ± X bpm/g/dl criteria. The document states "The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population."

Study Details

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • SpO2: Not explicitly stated, but "human blood studies on healthy adult male and female volunteers... with light to dark skin pigmentation." The studies involved inducing hypoxia.
  • SpHb: Not explicitly stated, but "blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation."
  • Pulse Rate: Not explicitly stated, but "healthy adult male volunteers and on patients with light to dark skin pigmentation."
• Data Provenance: The studies were conducted on "healthy adult male and female volunteers" and "patients," suggesting prospective clinical studies. The country of origin is not specified, but the submission is to the U.S. FDA, implying the studies were likely conducted to meet U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Not Applicable. This device measures physiological parameters directly. The "ground truth" was established using established reference methods, not expert consensus.

4. Adjudication Method (Test Set)

• Not Applicable. As the ground truth was established by direct reference measurements, there was no adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a medical device for direct measurement of physiological parameters, not an imaging or diagnostic algorithm that assists human readers. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance

• Yes. The reported "Clinical Results" directly reflect the performance of the device (algorithm and hardware) in measuring SpO2, Pulse Rate, and SpHb against reference standards. This is a standalone performance assessment.

7. Type of Ground Truth Used (Test Set)

• Reference Measurements:
  • SpO2: Compared against a "laboratory CO-oximeter and ECG monitor."
  • SpHb: Compared against a "laboratory CO-oximeter."
  • Pulse Rate: Compared against an unspecified reference in the range of 40-110 bpm, likely an ECG or other validated heart rate monitor.
• Compliance: The clinical studies were performed in accordance with ISO 9919:2005, which specifies requirements for pulse oximeters.

8. Sample Size for the Training Set

• Not explicitly stated in the provided text. The document describes clinical validation studies but does not detail the size of any potential dataset used for training the device's algorithms.

9. How the Ground Truth for the Training Set Was Established

• Not explicitly stated in the provided text. Assuming there was a training phase for the device's algorithms, the ground truth would likely have been established using similar reference methods (laboratory CO-oximeters, ECG monitors) as for the test set, but details are not provided.

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