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The VTRUST Finger Type Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.

This device is indicated for non-invasive spot checking.

The proposed device is a finger type device which is designed for non-invasive spot checking of functional arterial oxygen saturation (SpO2) and pulse rate for adults based on the principle of spectrophotometry.

The proposed device utilizes the conventional oximetry technology. The sensor contains a dual light source (red and infrared light-emitting diodes) and photo-detector (photodiode). The photo-detector senses the light signal and the sensor converts this electrical information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude.

The proposed device has approved under water resistant and dust resistant level IPS6.

The provided text describes a 510(k) submission for the VTRUST Finger Type Pulse Oximeter, but it does not contain specific acceptance criteria, detailed study results, or the other requested information for a comprehensive study description.

However, based on the information provided, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text. For pulse oximeters, acceptance criteria typically involve accuracy (Root Mean Square - RMS, or bias and precision) for SpO2 and pulse rate against a co-oximeter reference, often across a range of saturations. These are usually defined based on international standards like ISO 80601-2-61.
• Reported Device Performance: The text generally states that a "Clinical study" (Attachment 4.5) confirmed the "performance, safety and effectiveness of the proposed device are equivalent to the predicate device." However, no specific performance metrics (e.g., accuracy, bias, precision values for SpO2 or pulse rate) are provided in the main summary.

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

• Sample Size for Test Set: Not specified. The document only mentions a "Clinical study" was performed.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Clinical studies for pulse oximeters are typically prospective and conducted by inducing controlled hypoxia in healthy volunteers.

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

• For pulse oximetry, "ground truth" for SpO2 is typically established using a co-oximeter measurement of arterial blood samples. This does not involve human experts in the same way an imaging study would. Therefore, this question is not directly applicable in the context of pulse oximeter accuracy testing.

4. Adjudication Method for the Test Set:

• Not applicable as the ground truth is established by a co-oximeter, not by expert consensus requiring adjudication.

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

• No. An MRMC study is relevant for diagnostic imaging or interpretation tasks involving human readers. For a pulse oximeter, the device directly measures physiological parameters. There's no "human reader" interpreting cases in the context of device accuracy, only the device's measurement against a reference standard.

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

• Yes, implicitly. The "Clinical study" would evaluate the device's (algorithm's) performance in measuring SpO2 and pulse rate directly against a reference standard (co-oximeter) without human intervention in the measurement process itself, beyond operating the device.

7. The Type of Ground Truth Used:

• Co-oximetry. For pulse oximeters, the gold standard for measuring arterial oxygen saturation (SaO2) is typically a laboratory co-oximeter analysis of simultaneously drawn arterial blood samples. The device's SpO2 readings are then compared to these SaO2 values.

8. The Sample Size for the Training Set:

• Not applicable / Not specified. Pulse oximeters typically use established physics-based algorithms (spectrophotometry) rather than machine learning models that require distinct "training sets" and "test sets" in the same way. While the algorithm may have been developed and refined using data, it's not a "training set" in the common machine learning sense for a clinical validation study. The document focuses on the validation of the final device.

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

• Not applicable. As above, the concept of a "training set" for ground truth establishment isn't directly relevant in the device's described operating principle. Algorithm development would rely on accurate physiological models and data, likely using co-oximetry as the reference, but this isn't a separate "training set" in the context of this 510(k) submission.

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