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The Finger Type Pulse Oximeter is indicated for use in measuring oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for patients during no-motion. The patients are limited to adults with weight above 40 kg. This device is indicated for non-invasive spot checking.

The main function of Finger Type Pulse Oximeter is same as the predicate's to monitor the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Except for the general feature, Finger Type Pulse Oximeter also has the wireless data transmission function which transmits the readings of SpO2 and pulse rate from the Finger Type Pulse Oximeter to the personnel device via Bluetooth pairing. The personnel device may include the smart phone, tablet PC and so on.

Here's an analysis 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

Note: The acceptance criteria for SpO2 accuracy are not explicitly stated for the proposed device in a single, clear row like the predicate. Instead, the reported performance is given as new ranges. The text indicates that the device met the criteria of ISO 80601-2-61:2011, which would define the specific accuracy requirements. The summarized performance in section 8 suggests the accuracy around 70-79% is ±3% and 80-100% is ±2%, with an Arms value of 2.0 (for 70-100%).

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

• Sample Size: 14 healthy adult male and female volunteers.
• Data Provenance: Prospective, clinical evaluation performed by the manufacturer, or a facility contracted by them (details about the specific country/location are not explicitly stated beyond "Taiwan" for the company but implies this clinical study was done for this submission). The study involved inducing desaturation in the volunteers.

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

The document does not mention experts being used to establish a ground truth. For pulse oximetry accuracy studies, the ground truth is typically established by directly sampling arterial blood and measuring the oxygen saturation using a co-oximeter (considered the gold standard). The text states "The clinical evaluation was conducted and the result of Finger Type Pulse Oximeter is in compliance with the criteria of ISO 9919 standard and FDA guidance - "Pulse Oximeter Premarket Notification Submissions"." This implies a standard methodology for comparing the device's readings against a reference method (likely arterial blood gas analysis), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy tests is typically objective measurements from co-oximetry, not subjective interpretations requiring adjudication.

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 standalone medical measurement device (pulse oximeter), not an AI-assisted diagnostic tool that would involve human readers or interpretation improvement.

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

Yes, a standalone performance study was done. The entire accuracy study described (clinical evaluation against ISO 9919 and FDA guidance) is a standalone performance assessment of the device's ability to measure SpO2 and pulse rate.

7. The Type of Ground Truth Used

The ground truth used for the SpO2 accuracy study is physiological measurement (likely arterial blood gas analysis/co-oximetry). This is implied by the adherence to ISO 9919 and FDA guidance for pulse oximeter submissions, which mandate comparison to a laboratory co-oximeter.

8. The Sample Size for the Training Set

Not applicable. This device does not appear to utilize machine learning or AI in a way that requires a separate "training set" for an algorithm. It measures physiological signals.

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

Not applicable, as there is no mention of a training set or a machine learning algorithm.

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