(173 days)
This SpO2 Sensor is intended for the continuous nonitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.
The SpO2 Sensor consists of compatible connectors, cable, patient side sensor. And one side of sensor is designed to locate light emitting diodes (LEDs) and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2).
The U401 series SpO2 Sensor acts as re-usable accessory of Mindray PM-8000 Express Patient Monitor, which has been cleared by K070791. And the function alarms and interface accessories are controlled by the monitor, and such information is not available in this submission.
Here's a breakdown of the acceptance criteria and study information for the SpO2 Sensor U401-A, U401-B, U401-C, U401-D, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SpO2 Accuracy | +/- 2% |
| Pulse Rate Range | 20 bpm - 250 bpm |
| Pulse Rate Accuracy | +/- 2 bpm |
| SpO2 Range | 70% - 100% |
Note: The document explicitly states the SpO2 accuracy of the subject device is ±2%, which is better than the predicate's ±3%. This suggests the acceptance criterion for SpO2 accuracy would have been ≤ ±3% (or a target of ±2% as achieved). The Pulse Rate Accuracy is also better than the predicate's ±3 bpm.
Study Details
2. Sample size used for the test set and the data provenance
- Sample Size: The document states "The volunteer population in the studies composed of local healthy men and women from age 18 to 55, with variations of skin pigmentations." It also specifies that "darkly pigmented subjects are included in the desaturation study is three." However, the exact total number of human subjects (the sample size) is not explicitly stated in the provided text, beyond mentioning the composition of the volunteer population.
- Data Provenance: The study was conducted with "local healthy men and women," implying it was conducted domestically where the manufacturer is located (Shenzhen, P.R. China), or where the clinical study site was. The study involved human subjects undergoing desaturation, which is a prospective clinical study methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: This information is not provided in the text.
- Qualifications of Experts: This information is not provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document references the "Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment." This guideline details methods for determining accuracy against a reference, but it does not specify an adjudication method in the context of expert review for a test set. The ground truth method described (CO-oximeter) is a direct physiological measurement, not an interpretative expert 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
- Not applicable. This device is an SpO2 sensor, which provides direct physiological measurements (SpO2 and pulse rate). It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or an MRMC study.
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 data section describes the device's accuracy being validated against arterial blood samples measured with a CO-oximeter. This directly assesses the algorithm's (or the device's) performance in determining SpO2 and pulse rate without human interpretation as part of the measurement process. The device's specified SpO2 Accuracy of +/- 2% and Pulse Rate Accuracy of +/- 2 bpm are results of this standalone testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: For the clinical study, the ground truth for SpO2 accuracy was established using arterial blood sample reference measured with a CO-oximeter.
8. The sample size for the training set
- Not applicable. This device is a sensor that directly measures physiological parameters. The provided documentation does not describe a machine learning algorithm that requires a separate "training set" in the context of AI. The "clinical data" section pertains to the validation of the device's accuracy.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated in point 8.
§ 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).