(300 days)
The SLP OxSAT 100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible PSG and/or HST device. It is not intended for use with low perfused patients.
The SLP OxSAT 100 is a pulse oximeter module that photoelectrically determines the oxygenation of blood in a part of the body, based upon the sensor placement.
The OxSAT 100 contains the electronics to interface to an attached sensor. The red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood.
The OxSAT 100 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), Pulse rate and plethysmographic data to compatible polysomnogram ("PSG") and/or home sleep testing ("HST") devices.
Pulse amplitude is not displayed. The OxSAT 100 is powered by the host monitor. The wavelength of red LED is 660nm and Infrared LED is 910 nm with maximum optical output power of less than 1 mW.
The OxSAT 100 Module is not intended for use with skin contact and, therefore, has not been tested for biocompatibility. The OxSAT 100 is either attached to the outside of a belt on the patient or is set off to the side of the bed. An extension cable might be used with the sensors to avoid skin contact.
The provide text describes the 510(k) premarket notification for the OxSAT 100 oximeter module and its substantial equivalence to a predicate device, the Nonin Model 4100. It focuses on the device's characteristics, intended use, and compliance with standards. It does not contain information about acceptance criteria, study methodologies for AI/ML performance, ground truth establishment for a test set, expert adjudication, or MRMC studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as it explicitly asks for details related to AI/ML device evaluation which are not present in the provided document. The document describes a traditional medical device (oximeter) and its performance testing against engineering and medical standards, not AI algorithm performance.
The document only states that "Testing to ensure clinical accuracy of the device in accordance with ISO 80601-2-61. This testing and results showed compliance to the standard." Without access to the specific details of the ISO 80601-2-61 standard and the test results, it is impossible to extract the requested information.
§ 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).