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Med-link Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals, physician's office, clinical settings and home care environment. It's a reusable device intended for adults and pediatrics who are well or poorly perfused.

Device Description

Med-Link Pulse Oximeter is to spot-check oxygen saturation in blood (SpO2) and pulse oximeter is used on adults and pediatrics at hospital, clinics, and/or home. The device mainly consists of power supply module, detector and emitter LED, signal collection and processor module, user interface and button control. There is no visual or audio alarm. The device is reusable and non-sterile. The device has AM801. The device contains a dual light source (Red LED and Infrared red LED) and a photo detector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed in an oxygen saturation measurement (SpO2). Because a measurement of SpO2 is dependent on light from the device, excessive ambient light can interfere with this measurement. The wavelength of red LED is 660mm and infrated LED is 905nm with maximum optical output power of 15mW.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Std. ISO 80601-2-61)	Reported Device Performance (Med-link Pulse Oximeter)	Pass/Fail
SpO2 Accuracy	ARMS value ≤ 3% within the range of 70-100% SaO2 (per ISO 80601-2-61)	Overall ARMS value ≤ 3% within the range of 70-100% SaO2	Pass
SpO2 Range	(Implied by accuracy testing range) 70-100%	70% to 100%	Pass
SpO2 Resolution	Not explicitly stated as acceptance criteria, but common for pulse oximeters is 1%	1%	Pass
SpO2 Accuracy (good perfusion)	90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified.	90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified.	Pass
SpO2 Accuracy (low perfusion)	90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified.	90% to 100% range: ±2%; 70% to 89% range: ±3%; <70%: unspecified.	Pass
Pulse Rate Accuracy	(Implied by general performance standards)	±3 bpm (good perfusion), ±3 bpm (low perfusion)	Pass
Operating Principle	Meets the requirements of ISO 80601-2-61	Uses dual light sources (Red LED 660nm, Infrared LED 905nm) and photodetector.	Pass
Biocompatibility	Meets ISO 10993-5 and ISO 10993-10	No cytotoxicity, significant irritation, or evidence of sensitization.	Pass
Electrical Safety	Compliance with IEC 60601-1	Complies with IEC 60601-1	Pass
EMC	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2	Pass
Performance	Compliance with ISO 80601-2-61	Complies with ISO 80601-2-61	Pass
Software V&V	Complies with FDA Guidance, "moderate" level of concern	Successfully passed Function Module Test, Main Performance Test, System Integrated Test.	Pass

Note: The specific acceptance criteria for SpO2 and Pulse Rate accuracy are directly stated in the comparison table within the 510(k) summary as the device's specifications, and the clinical study confirms the SpO2 accuracy "pass[es] a SpO2 accuracy specification of 3%".

Study Details:

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

Sample Size: 12 healthy adult volunteer subjects.
Data Provenance: Prospective clinical study conducted in China (Yue Bei People's Hospital).

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

The document does not specify the number of experts.
The ground truth was established by Reference CO-Oximetry, a standard laboratory method for measuring functional SaO2 from arterial blood samples. The expertise required would be in performing and interpreting these laboratory tests, but specific qualifications are not mentioned.

4. Adjudication method for the test set:

Adjudication method is not applicable in this context as the ground truth was derived from objective laboratory measurements (CO-Oximetry) rather than expert review of images or clinical assessments requiring adjudication. The comparison was directly between the device's reading and the CO-Oximetry result.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of the device against a gold standard (CO-Oximetry) rather than comparing human reader performance with and without AI assistance.

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

Yes, the clinical study evaluated the "Shenzhen Med-link Pulse oximeter" directly, measuring its SpO2 accuracy performance compared to arterial blood CO-Oximetry. This represents the standalone performance of the device's measurement algorithm.

7. The type of ground truth used:

Outcomes Data / Laboratory Gold Standard: The ground truth for SpO2 accuracy was established using arterial blood CO-Oximetry, which is considered the gold standard for directly measuring arterial oxygen saturation (SaO2).

8. The sample size for the training set:

The document does not mention a separate training set or its sample size. Pulse oximeters typically rely on physical principles and calibration, not machine learning models that require a distinct training set in the same manner as AI algorithms for image classification, for example. The clinical study described is for validation.

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

As no separate training set is mentioned in the context of machine learning, this question is not applicable based on the provided information. The device's underlying principles are based on established spectroscopy and signal processing for pulse oximetry.

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