(129 days)
Unimed Disposable and Reusable 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 40kg, pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.
The Unimed Disposable and Reusable SpO2 Sensors are a family of oximeter sensors designed to function the same as the compatible Original Equipment Manufacturer (OEM) Pulse Oximeter Sensor.
The sensors contain two specific wavelength LEDs and a photo detector assembled into the sensor housing. The sensor cable terminates into an OEM compatible connector. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter.
Four types of sensor housings are described in this submission:
- Reusable soft tip sensor comprised of an integrated silicone rubber tip.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable non- adhesive sensor with sponge and velcro backing.
- Disposable adhesive sensors constructed of a medical tape laminate.
Each sensor has unique labeling and specifications designed for compatibility with the specific monitor (Nellcor, Nonin, BCI, Ohmeda).
The Unimed Disposable and Reusable SpO2 Sensors were evaluated through clinical testing, specifically a clinical hypoxia study, to establish their accuracy.
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the clinical test results but does not provide a table with specific numerical acceptance criteria or detailed performance metrics like accuracy range (e.g., A_rms value) against arterial oxygen saturation (SaO2). It broadly states that "Clinical test results support device accuracy claims for the specified saturation range."
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Clinical hypoxia test results were obtained in human adult volunteers."
- Sample Size: Not explicitly stated, though it refers to "human adult volunteers" (plural), indicating more than one.
- Data Provenance: The study was "prospective" as it involved "clinical hypoxia test results obtained in human adult volunteers" under an "approved protocol with subject informed consent." The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The ground truth (SaO2) was determined by co-oximetry, which is a laboratory measurement. While experts would be involved in performing and interpreting co-oximetry, the document doesn't detail their number or qualifications as it pertains to establishing the ground truth for the test set.
4. Adjudication Method for the Test Set:
This is not applicable as the ground truth was established by co-oximetry, which is a quantitative measurement, not a subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device itself against a clinical standard (co-oximetry), not on how human readers improve with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the clinical hypoxia test evaluated the standalone performance of the Unimed Disposable and Reusable SpO2 Sensors. The study assessed the device's accuracy in continuously monitoring SpO2 and pulse rate against arterial oxygen saturation (SaO2) determined by co-oximetry. There is no mention of a human-in-the-loop component in this specific clinical test.
7. The Type of Ground Truth Used:
The ground truth used was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective laboratory measurement from arterial blood samples.
8. The Sample Size for the Training Set:
This information is not provided. The document describes a clinical "validation" study (test set), not a study focused on training a model.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. As mentioned above, the document describes a validation study for the device, not a training study for an algorithm.
§ 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).