(151 days)
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) are fully compatible reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The DBI/P Sensors are also fully compatible for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-oximeter monitors. Additionally, the DBI Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.
Here's a breakdown of the acceptance criteria and study information for the Masimo SET Reusable Soft Oximetry Sensors, based on the provided text:
Acceptance Criteria and Device Performance
| Feature | Acceptance Criteria (Masimo SET & Rainbow SET Technology) | Reported Device Performance (with Masimo SET & Rainbow SET Technology) | Acceptance Criteria (Nellcor & Nellcor Compatible Technology) | Reported Device Performance (with Nellcor & Nellcor Compatible Technology) |
|---|---|---|---|---|
| Accuracy – SpO₂ During No Motion Conditions | ||||
| Adults, Pediatrics: 70% - 100% | ± 2% | ± 2% | ± 2% | ± 2% |
| Adults, Pediatrics: 0% - 69% | Unspecified | Unspecified | Unspecified | Unspecified |
| Accuracy – SpO₂ Low Perfusion | ||||
| Adults, Pediatrics: 70% - 100% | ± 2% | ± 2% | N/A | N/A |
| Adults, Pediatrics: 0% - 69% | Unspecified | Unspecified | N/A | N/A |
| Accuracy – Pulse Rate During No Motion Conditions | ||||
| Adults, Pediatrics: 25 - 240 bpm | ± 3 bpm | ± 3 bpm | ± 3 bpm | ± 3 bpm |
| Accuracy – Pulse Rate Low Perfusion | ||||
| Adults, Pediatrics: 25 - 240 bpm | ± 3 bpm | ± 3 bpm | N/A | N/A |
Note: The document explicitly states that "The DBI/P Sensor performance is equivalent to those of the LNCS Oximetry Sensor." The reported device performance in the table above is directly taken from the "SENSOR SPECIFICATIONS" provided in the 510(k) summary, which outlines the expected performance and thus serves as the acceptance criteria that the device is stated to meet.
Study Details:
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Sample size used for the test set and the data provenance:
- The provided document does not specify the sample size for the clinical testing.
- The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical Testing" as one of the quality assurance measures.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The provided document does not contain any information regarding the number of experts or their qualifications used to establish ground truth. For pulse oximeters, the reference standard (ground truth) is typically established by laboratory co-oximeters measuring arterial blood gas samples.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The provided document does not specify any adjudication method.
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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, a MRMC comparative effectiveness study was not done. This device is a pulse oximeter which directly measures physiological parameters and does not involve human interpretation or AI assistance in the way a diagnostic imaging device might.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance was done. The performance specifications listed in the table directly represent the standalone accuracy of the device. Pulse oximeters are designed to provide direct measurements without human-in-the-loop interaction for the core SpO2 and pulse rate readings. The term "algorithm only" isn't directly applicable in the same way as machine learning models, but the specifications are for the device's inherent measurement capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- While not explicitly stated in this summary, the standard practice for pulse oximeters involves using laboratory co-oximetry of arterial blood gas samples as the gold standard (ground truth) for oxygen saturation, and often an ECG for heart rate or specific reference pulse oximeters for pulse rate accuracy.
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The sample size for the training set:
- This document describes a medical device, not a machine learning algorithm in the typical sense of a "training set." Therefore, the concept of a "training set" with a specified sample size in the context of machine learning does not apply here. The device's design and parameters are established through engineering and physiological principles, not through a data-driven training process.
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How the ground truth for the training set was established:
- As explained above, the concept of a "training set" for a device like a pulse oximeter does not apply. The device is designed based on known physiological principles and validated through clinical testing 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).