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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 healthcare environment. And it is not intended to be used under motion or low perfusion scenarios.

The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpQ2), The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. Bluetooth function is available for Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30B, Alpine30BA, Alpine30BH, Alpine20LB, Alpine20LB, Alpine20LBH, Alpine30LB and Alpine30LBH only.

Here's a breakdown of the acceptance criteria and study details for the Fingertip Pulse Oximeter, based on the provided document:

This document describes a 510(k) premarket notification for a medical device, which means the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy from scratch. Therefore, the "acceptance criteria" discussed here are primarily focused on meeting regulatory standards and demonstrating comparable performance to the predicate device, rather than establishing de novo clinical effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance claims for this pulse oximeter relate to SpO2 accuracy and Pulse Rate accuracy. The acceptance criteria are implicitly defined by the standard ISO 80601-2-61 and the device's stated accuracy, which is compared directly to the predicate device.

Note on SpO2 Range Difference: The document explicitly states and justifies the difference in SpO2 range. While the predicate measures 0-100%, the subject device measures 35-100%. The justification is that this difference is acceptable as it aligns with the verification per ISO 80601-2-61.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Test Set): 12 adult healthy volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It describes the study as "Clinical testing conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2017... and the FDA Guidance Document for Pulse Oximeters." This suggests it was a prospective study designed to meet these specific guidelines. The volunteers had varying skin tones (Fitzpatrick I-VI), indicating an effort for demographic representation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of device (pulse oximeter) does not typically involve expert readers for ground truth establishment. The ground truth for SpO2 accuracy is based on arterial blood CO-Oximetry, which is considered the gold standard for measuring blood oxygen saturation. This is a direct physiological measurement and does not require subjective expert interpretation in the same way imaging studies might.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by direct physiological measurement (CO-Oximetry), which does not involve subjective interpretation or a need for adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI algorithms where human readers interpret medical images, and the AI is used to assist or replace human interpretation. A pulse oximeter directly measures physiological parameters and does not involve human interpretation of complex medical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the core performance testing of the device for SpO2 and Pulse Rate accuracy is a standalone assessment of the algorithm's ability to measure these parameters against the gold standard (CO-Oximetry). The device operates independently to provide these measurements.

7. The Type of Ground Truth Used

The type of ground truth used was outcomes data / physiological measurement, specifically: arterial blood CO-Oximetry. This is the standard reference method for determining actual arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not provide information on the training set size. For a medical device like a pulse oximeter, "training" might refer to the development and calibration of the internal algorithms and hardware during the design phase, rather than a distinct "training set" of data in the common machine learning sense used for AI algorithms. The clinical study described served as the validation test set.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how a "training set" ground truth was established. The focus of this 510(k) submission is on validating the final device's performance against established standards (ISO 80601-2-61) and comparing it to a predicate device, using clinical data collection and CO-Oximetry as ground truth for that validation. If there were internal iterative development and calibration, the specifics of those processes are not detailed in this public regulatory summary.

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