(90 days)
The Reusable and Disposable 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. The sensors are intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.
The proposed device, Reusable and Disposable SpO2 sensors are the accessory of the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.
The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), and it is used to attach the patient's finger and measure oxygenation of blood from detecting the infrared-light and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation values and heart rate conditions.
The Reusable and Disposable SpO2 sensors consist of compatible connectors, cable, and patient sensor terminal. And the optical components of sensor are designed to a light emitting diode and a light detector. Red and Infrared lights are shone through the terminal tissues. Then parts of the emitting lights are absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. The light detector detects the light volume transmitted through the tissues on the basis of blood pulse, then the microprocessor calculates a value for the oxygen saturation by measuring the absorbance of the wave peak and the wave trough. The saturation values are determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
This document describes a 510(k) premarket notification for reusable and disposable SpO2 sensors. It details performance data, including biocompatibility, electrical safety, EMC, and clinical studies. However, the document does NOT contain information about AI/ML models or their performance, nor does it specify acceptance criteria for such models, or the details of ground truth establishment by experts for AI/ML development.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML, as the provided text pertains to a standard medical device (SpO2 sensor) without any indication of AI components.
To answer your question accurately, I would need a document that describes the performance of an AI-powered medical device.
§ 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).