(160 days)
Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.
The subject devices, Unimed Reusable Finger Clip SpO2 Sensors, are fully compatible reusable sensors for use with monitors that incorporate Masimo technology. These sensors are supplied non-sterile. The subject sensors consist of a plug/connector (U403-125 and U103-125 with M8 sensor connector, and U403-254 and U103-254 with M10 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensors have identical material composition and performance characteristics to the predicate device.
Here's a breakdown of the acceptance criteria and study information for the Unimed Reusable Finger Clip SpO2 Sensors, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Comparison |
|---|---|---|---|
| Saturation Accuracy, No Motion (70-100%) | ± 3% | ± 3% | Identical |
| Pulse Rate Accuracy, No Motion (30-250 bpm) | ± 3 bpm (30-250 bpm) | ± 3 bpm (30-250 bpm) | Identical |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the clinical study was conducted with "human adult volunteers," including "sufficient darkly pigmented subjects." However, the exact number of subjects (the sample size) is not specified.
- Data Provenance: The data is prospective as it was collected in a "clinical study... under an approved protocol with subject informed consent." The country of origin is not explicitly stated, but the submission is from "Unimed Medical Supplies Inc." located in "Shenzhen, China." It's reasonable to infer the study was conducted there or arranged by their organization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document mentions that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used to establish the ground truth. This is a direct physiological measurement and does not involve human expert interpretation for ground truth establishment. Therefore, information about the number or qualifications of experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth was established by co-oximetry, which is an objective measurement, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an oximeter sensor, which directly measures physiological parameters (SpO2 and pulse rate). Its performance is evaluated against a gold standard method (co-oximetry), not by comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the clinical study performed appears to be a standalone (algorithm only) performance evaluation. The device, an SpO2 sensor, directly provides measurements. The study evaluated the accuracy of these measurements against a reference method (co-oximetry) without integrating a human in the loop for interpreting the device's output.
7. Type of Ground Truth Used
The ground truth used was outcomes data (physiological measurements), specifically "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is considered a clinical gold standard for measuring blood oxygen levels.
8. Sample Size for the Training Set
Not applicable. The document describes a medical device (SpO2 sensor), not an AI/machine learning algorithm that requires a training set. The device operates based on physical principles (two-wavelength relative optical absorption) and is validated through clinical performance against a reference standard.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/machine learning algorithm, there is no training set and therefore no ground truth established for a training set.
§ 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).