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The Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use indicated for measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It may be used for spot checking, intermittent monitoring, and/or data collection of patients 12 years and older in low acuity settings in facilities such as hospitals, clinics and doctor's offices. It can also be used in home healthcare settings under prescription use. It is not intended for continuous monitoring.

Oxxiom Pulse Oximetry System is a wireless, fully disposable, single-use device for measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). lt also measures Pulse Amplitude (PA). It is a prescription device for spot checking, intermittent monitoring, and data collection.

Oxxiom has two main components, the Oxxiom device (hardware device) and the Oxxiom Rx App. Oxxiom also provides tape to apply the device to the finger. Oxxiom also requires the use of an iOS display device, such as an iPhone, iPad, or iPod, that has iOS version 10.1 or later. The iOS device is not provided with the Oxxiom Pulse Oximetry System.

Oxxiom is small, lightweight, and has a 24-hour battery life. The device simultaneously, and wirelessly transfers all collected data through a Bluetooth connection to the Oxxiom App on the iOS device, which analyzes data, displays information, provides warnings as necessary, and stores the information.

Oxxiom has been tested on a subject population with devices placed on the finger. Monitoring at other sites of the body is not recommended. The principle of operation is based upon the noninvasive reflectance of red and infrared light.

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

1. A table of acceptance criteria and the reported device performance

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

• Sample Size (Clinical Evaluation): 10 subjects
• Data Provenance: The study was a "comparative, single-center, non-randomized study." While the country of origin isn't explicitly stated, it can be inferred that it likely occurred in the US given the FDA submission. The clinical evaluation describes a prospective study where arterial blood samples were taken to establish a ground truth.

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

The ground truth for the clinical evaluation was established using CO-Oximetry on arterial blood samples. This is an objective measurement from a medical device, rather than a subjective assessment by human experts. Therefore, no information is provided regarding the number or qualifications of experts for establishing ground truth in this specific context.

4. Adjudication method for the test set

Not applicable. The ground truth was established by CO-Oximetry, which is an objective measurement, not requiring an adjudication method like 2+1 or 3+1 by human experts.

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 document describes a clinical evaluation of a pulse oximetry system, not an AI-assisted diagnostic tool. No MRMC study was conducted, nor is there any mention of AI assistance for human readers.

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

Yes, the clinical evaluation described is a standalone performance test of the device (Oxxiom Pulse Oximetry System) against a reference standard (CO-Oximetry). It assesses the device's ability to accurately measure SpO2 without human intervention in the measurement process itself, beyond initial setup.

7. The type of ground truth used

The ground truth used for the clinical evaluation was arterial blood samples assessed by CO-Oximetry (SaO2). This is a highly accurate and objective method for determining arterial oxygen saturation.

8. The sample size for the training set

The document does not provide information about a "training set" in the context of machine learning or AI. The described studies are primarily for performance validation of the measurement technology itself, not for training a predictive model.

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

Not applicable, as no training set (for machine learning/AI) is described in the provided text.

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