(458 days)
Shenzhen Med-link disposable probe, model S0136J-L, is indicated for single patient use when continuous, non-invasive arterial oxygen saturation and pulse rate monitoring are required for adult patients or pediatric patients weighing more than 30 kg. The S0136J-L is contraindicated for use with patients during motion condition.
Shenzhen Med-link Pulse Oximeter Probes are electro-optical probes which function without skin penetration, electrical contact, or heat transfer. The probes use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The probe contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in silicon rubber pads. These SpO2 probes not made with natural rubber latex.
The Shenzhen Med-Link Pulse Oximeter Probe, model S0136J-L, was tested to ensure its performance and safety, primarily focusing on SpO2 accuracy and pulse rate accuracy.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO 9919:2005) | Reported Device Performance (Shenzhen Med-Link S0136J-L) |
|---|---|
| SpO2 Accuracy (70-100%): | SpO2 Accuracy (70-100%): |
| 70-100%: ±2% (Predicate device standard) | 70-100%: ±3% |
| 70-80%: ±2% | 70-80%: ±3% |
| 80-90%: ±2% | 80-90%: ±2% |
| 90-100%: ±2% | 90-100%: ±2% |
| Pulse Rate Accuracy (20-250 bpm): | 20 to 250 bpm ±3 digits |
| 20 to 250 bpm ±3 digits | |
| Excessive Temperature: | |
| Does not exceed 41°C at probe-tissue interface at 35°C ambient temperature | Does not exceed 41°C at probe-tissue interface at 35°C ambient temperature |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "clinical testing to validate the performance and accuracy of the probes under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." However, it does not specify the exact sample size of subjects used for this clinical test set.
The data provenance is prospective, as indicated by the description of the clinical study, which involved "all testing performed under an institutionally approved protocol with subject informed consent." The country of origin of the data is not explicitly stated, but it can be inferred to be from the location where the clinical study was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth for SpO2 accuracy was determined by "arterial oxygen saturation as determined by co-oximetry." This implies instrumental measurement as the "ground truth" rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set, as the ground truth was established by co-oximetry, which is an objective measurement rather than a subjective interpretation requiring adjudication among experts.
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:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a pulse oximeter probe, not an AI-assisted diagnostic tool that requires human interpretation of images or data. Therefore, the concept of human reader improvement with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was conducted for the device. The clinical study evaluated the performance of the Shenzhen Med-link Probe itself in determining SpO2 accuracy under controlled hypoxia, compared to co-oximetry as the reference standard. This is a direct measure of the device's algorithmic performance.
7. The Type of Ground Truth Used:
The ground truth for SpO2 accuracy was arterial oxygen saturation as determined by co-oximetry. This is an objective, instrumental measurement of the true physiological value.
8. The Sample Size for the Training Set:
The document does not specify a separate training set or its sample size. For a medical device like a pulse oximeter, the "training" typically refers to the development and calibration of the internal algorithms based on physiological principles and empirical data, rather than a distinct machine learning training set in the conventional sense. The "clinical testing" described serves as the validation or test set against which the device's performance is measured.
9. How the Ground Truth for the Training Set Was Established:
As no distinct training set for an AI/ML algorithm is described in the context of this traditional medical device, the concept of establishing ground truth for a training set in that manner is not applicable. The device's internal algorithms would have been developed based on established physiological models of light absorption by oxygenated and deoxygenated hemoglobin, and calibrated using data that correlates pulse oximetry readings with gold standard co-oximetry measurements during the device's development process. Details of this development process are not provided in the summary.
§ 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).