(225 days)
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, and ambulatory surgery centers).
The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories include the noninvasive technology spot check 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. This submission introduces two new sensor sizes (medium and small) and an optional Maximum Sensitivity Mode that extends the detection range for SpHb.
Here's analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Accuracy | 70-100% ± 2% | SpO2 accuracy (rms) of ± 2% |
| Pulse Rate Accuracy | 30-250 bpm ± 3 bpm | Pulse rate accuracy (rms) of ± 3bpm |
| SpHb Accuracy (Normal Sensitivity Mode) | 6-18 g/dl ± 1 g/dL | SpHb accuracy (rms) of ± 1g/dl |
| SpHb Accuracy (Maximum Sensitivity Mode) | Not applicable (New mode for subject device) | SpHb accuracy (rms) of ± 1.1g/dl (for 4.5-20 g/dl range) |
Study Information
The provided text details multiple performance validations for SpO2, SpHb, and Pulse Rate accuracy.
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Sample Size used for the test set and the data provenance:
- SpO2 Accuracy: "human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation." No specific number of volunteers given. The study involved inducing hypoxia.
- SpHb Accuracy: "with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation." No specific number of volunteers/patients given.
- Pulse Rate Accuracy: "on healthy adult male and female volunteers and on patients with light to dark skin pigmentation." No specific number of volunteers/patients given.
- Data Provenance: The studies were conducted with "human blood" and "volunteers/patients," suggesting prospective clinical studies. The country of origin is not explicitly stated, but it's likely the US given the FDA submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- SpO2: Ground truth was established by "a laboratory CO-Oximeter and ECG monitor." No human experts are mentioned for ground truth establishment; instrumentation provided the reference.
- SpHb: Ground truth was established by "a laboratory CO-Oximeter." No human experts are mentioned for ground truth establishment; instrumentation provided the reference.
- Pulse Rate: Ground truth was established by an unspecified method; often this is also derived from ECG or another reference monitor. No human experts are mentioned.
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Adjudication method for the test set:
- Not applicable. The ground truth was established by reference devices (laboratory CO-Oximeter, ECG monitor), not through human expert adjudication.
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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 MRMC comparative effectiveness study was conducted. This device is an oximeter, which provides direct measurements (SpO2, SpHb, Pulse Rate) and does not involve human "readers" interpreting images or data that an AI might assist with.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented is for the device (algorithm and sensor) operating in a standalone capacity. The accuracy metrics (rms of SpO2, Pulse Rate, SpHb) are direct measurements of the device's performance against reference standards. It's a "spot check" device, meaning it provides a reading without continuous human interaction for interpretation beyond reading the display.
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The type of ground truth used:
- Instrumentation-based ground truth:
- For SpO2, a "laboratory CO-Oximeter and ECG monitor" served as the reference.
- For SpHb, a "laboratory CO-Oximeter" served as the reference.
- For Pulse Rate, accuracy was validated, but the specific reference ground truth instrument is not explicitly named, though usually, an ECG monitor would be used.
- Instrumentation-based ground truth:
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The sample size for the training set:
- The document does not explicitly mention a "training set" or its sample size. Oximeters typically use empirical models and calibrations developed from extensive physiological data, rather than a distinct "training set" in the machine learning sense for each submission. This submission focuses on validation of the device's accuracy.
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How the ground truth for the training set was established:
- As no specific "training set" is described, the method for establishing its ground truth is not provided. The device's underlying technology is stated to be the "same" as the predicate device, implying that the foundational calibration and algorithms were likely established in prior, more extensive studies. The current submission focuses on validating the performance of new sensor sizes and an extended sensitivity mode against established reference methods.
§ 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).