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The Oxitone Model 1000 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.

It is intended for spot-checking of adult patients with wrist between 13-22 cm circumferences in hospitals, clinics, long-term care, and home use.

The Oxitone 1000 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a part of the body, in this case the wrist.

This Oxitone 1000 contains the electronics, interface and sensor. The Oxitone pulse oximeter is mounted on a watch-like device and measures oxygen saturation at the wrist location. The Oxitone pulse oximeter exploits a reflectance sensor that includes the photodetector located at the wearer's Ulnar Bone near the Ulnar Bulge and a bi-color light source (LED's) that are located around the top of the wearer's Ulnar "Bulge", to align the light source properly to the Ulnar Bulge the LEDs surrounded by elastic concave shape surface. The Red and infrared light being transmitted through the tissue is partially absorbed by the blood oxyhemoglobin and is sensed by the photodetector. The blood oxygen saturation is measured using the well-established technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood that enables to calculate the blood functional pulse oximetry.

The Oxitone 1000 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the Oxitone 1000 displays digital values for both the SpO2 and Pulse.

Pulse amplitude is not displayed. The Oxitone 1000 is powered by an integral rechargeable Lithium Ion battery pack. The wavelength of red LED is 640nm and Infrared LED is 940 nm with maximum optical output power of less than 1 mW.

The device incorporates a battery state indicator and provides a visual indication of low battery.

Here's a breakdown of the acceptance criteria and study information for the Oxitone 1000, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to standards rather than directly listing acceptance criteria with detailed outcome metrics for each. The key performance metric explicitly stated is SpO2 accuracy.

Study Details

The document refers to clinical testing to ensure the clinical accuracy of the device.

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

   • Sample Size: 10 patients.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical testing... performed on 10 patients," suggesting a prospective study, likely conducted for this submission.

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

   • Not specified. The document states "Testing to insure clinical accuracy of the device in accordance with ISO 80601-2-61 was performed." ISO 80601-2-61 outlines methods for evaluating the accuracy of pulse oximeters, which typically involves comparing the device's readings to arterial blood gas measurements (co-oximetry) as the gold standard. It doesn't usually involve physician interpretation as ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. For pulse oximetry accuracy testing according to ISO standards, the "ground truth" is typically established by laboratory co-oximetry measurements, which are objective and do not require expert adjudication in the same way image-based diagnoses might.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Oxitone 1000 is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic.

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

   • Yes, the performance evaluation conducted (clinical accuracy testing, bench testing) represents the standalone performance of the Oxitone 1000 device algorithm in measuring SpO2 and pulse rate. There is no human-in-the-loop aspect for the core measurement functions.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical accuracy testing, the ground truth would typically be established by arterial blood gas measurements (specifically co-oximetry), which is an objective laboratory gold standard for oxygen saturation. This is implied by the reference to ISO 80601-2-61.

7. The sample size for the training set:

   • Not applicable/Not specified. The Oxitone 1000 is described as using "well-established technology" and "Photoplethysmography (PPG) signals." While algorithms are used to process these signals, the document does not suggest a machine learning model that would require a distinct "training set" in the modern AI sense. It's a measurement device based on established physiological principles and signal processing.

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

   • Not applicable, as there's no mention of a "training set" for a machine learning model in the context of this device's approval. The device's calibration and performance would be based on physiological models and established oximetry principles.

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