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The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

The Pulse Oximeter is intended for use 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 nm, 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 and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by smart phone and the measurement result will display on an Apple iPhone and Android phone. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

The provided text describes a 510(k) premarket notification for a Pulse Oximeter (LYOX01, K201294). The document outlines the device's intended use, its comparison to a predicate device, and the performance data submitted to support its substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for the clinical test set. It mentions "human adult volunteers" for the clinical hypoxia test.
The data provenance is implied to be prospective clinical studies as it refers to "Clinical testing has been performed under an approved protocol with subject informed consent." The document does not specify the country of origin, but given the manufacturer (Guangdong Long Yao Electronic Technology Co., Ltd. in China) and correspondent (Chonconn Medical Device Consulting Co., Ltd. in China), it is highly probable the clinical studies were conducted in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. However, it indicates that the ground truth for SpO2 was determined by "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is an objective measurement from a laboratory instrument and does not typically involve subjective expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. The ground truth for SpO2 was established by co-oximetry, which is an objective measurement and does not require an adjudication method among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a Pulse Oximeter, which directly measures physiological parameters (SpO2 and PR). It is not an AI-assisted diagnostic imaging or classification tool that would involve human readers or comparative effectiveness studies with human-in-the-loop AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation of the device was conducted. The clinical studies were performed to validate the accuracy of the Pulse Oximeter's measurements (SpO2 versus arterial oxygen saturation by co-oximetry and PR through validated methods, although PR method is less detailed in the summary). This implies evaluating the device's direct measurement capabilities, which is its standalone performance.

7. The type of ground truth used

The ground truth used for the clinical accuracy study was arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective, laboratory-based measurement considered the gold standard for oxygen saturation.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. Pulse oximeters are typically developed and validated based on biophysical principles and empirical calibration, not through machine learning models that require distinct training sets in the same sense as AI algorithms. The performance data presented refers to clinical validation.

9. How the ground truth for the training set was established

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this type of medical device validation.

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