(283 days)
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in home and healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
The Pulse Oximeter is a battery powered device in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 m, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, Bluetooth® module and plastic shell. There are five models AOJ-70A, AOJ-70C, AOJ-70E. Only AOJ-70E. Only AOJ-70D have wireless connection function via Bluetooth®. The device is a spot-check pulse oximeter and does not intended for life-supporting or life-sustaining.
The provided text is a 510(k) summary for a Pulse Oximeter (AOJ-70A-E). It describes the device, its intended use, and comparative testing to show substantial equivalence to a predicate device. However, it does not provide a table of acceptance criteria with reported device performance or information regarding a typical "AI/algorithm" study (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, types of ground truth, etc.). This document primarily focuses on regulatory compliance for a medical device (pulse oximeter), not an AI/ML-based diagnostic or assistive technology.
Therefore, I cannot fulfill the request as the necessary information (acceptance criteria table, detailed study design for an AI/ML model, expert data, ground truth establishment for AI/ML) is not present in the provided text. The text only mentions "software verification and validation testing" and "clinical data is referenced to K221039" for SpO2 accuracy, which refers to a standard medical device clinical trial for a pulse oximeter, not an AI/ML performance study.
The closest information found is the clinical study for SpO2 accuracy performance of the pulse oximeter itself, not an AI/ML component. Here's what is available regarding that:
Study on SpO2 Accuracy Performance (Not an AI/ML study):
- Study Name/Reference: Referenced to K221039.
- Location: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.
- Methodology: Conducted in accordance with ISO 14155-1, ISO 80601-2-61:2017, and FDA Guidance Document for Pulse Oximeters. Evaluated SpO2 accuracy performance during stationary (non-motion) conditions over a wide range of arterial blood oxygen saturation levels compared to arterial blood CO-Oximetry (which served as ground truth).
- Sample Size: 11 healthy adult volunteer subjects (ages 21-47yr, with skin tones varying from Fitzpatrick 2-6) were included.
- Ground Truth: Arterial blood CO-Oximetry.
- Reported Performance: The SpO2 accuracy performance results showed that the subject device had an ARMS (Accuracy Root Mean Square)
§ 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).