(60 days)
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fingertip Pulse Oximeter, structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily refers to the tolerance as the key performance metric.
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Tolerance smaller than ±2% | Tolerance smaller than ±2% |
| Range: 70% to 99% SpO2 | Range: 70% to 99% SpO2 |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%." However, it does not provide specific details on the sample size used for this clinical practice data nor explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature).
It does mention that the subject device (CMS-50D, CMS-50L, and CMS-50DL) is a modification to a previously cleared device (CMS-50C) and that "we believe the clinical test per ISO 9919 Annex EE.4 is not required to be conducted on the modified device." This implies that the performance data might be largely based on the predicate device or general clinical understanding rather than a dedicated new clinical trial for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The text refers to "clinical practice" for the tolerance, but it doesn't detail how ground truth for SpO2 was established in that context (e.g., comparison to arterial blood gas analysis performed by qualified personnel).
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in the provided document. The focus is on the device's standalone performance rather than comparing human readers with and without AI assistance. The device is a pulse oximeter, not an AI-assisted diagnostic tool for image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance evaluation was done for the device. The document states: "In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%." This refers to the device's ability to measure SpO2 independently. The specific details of the study (e.g., methods, number of subjects) are not explicitly outlined, but the statement indicates a standalone performance assessment.
7. Type of Ground Truth Used
The document implicitly refers to clinical practice measurements as the ground truth. For SpO2 measurements, the gold standard typically involves arterial blood gas analysis. While the document states "In the clinical practice, the tolerance is smaller than ±2%", it does not explicitly state that arterial blood gas analysis was used as the ground truth; however, this is a standard method for validating pulse oximeter accuracy in clinical settings.
8. Sample Size for the Training Set
This information is not applicable as the device described is a pulse oximeter, which is a sensor-based medical device, not an AI/algorithm that requires a training set in the typical machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (no training set for this type of device).
§ 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).