(222 days)
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment. The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
I am unable to answer this question. The provided text does not contain detailed information about the acceptance criteria for the Oxiband (Checkme) O2 Pulse Oximeter, nor does it describe a specific study proving the device meets these criteria in the structured format requested (e.g., test set sample size, expert qualifications, adjudication method, MRMC study, standalone performance, training set details).
While the document mentions non-clinical and clinical tests were performed and standards were met (e.g., ISO 80601-2-61 for SpO2 accuracy), it does not provide the granular details necessary to fill out all the requested fields. For example, it states "The SpO2 accuracy performance results showed the Checkme Pro Health Monitor with external SpO2 sensor to have an ARMS of 1.88 during steady state conditions over the range of 70%-100%", but it does not specify the sample size of subjects in this study, the provenance of the data, the methodology for establishing ground truth, or details about any human-in-the-loop studies.
Therefore, I cannot extract the requested information from the provided text.
§ 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).