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The Apnea Risk Evaluation System (ARES™), Model 610 is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES™ can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

The Apnea Risk Evaluation System (ARES™) includes a device called a Unicorder which records oxygen saturation, pulse rate, snoring level, head movement and head position, and airflow. Additionally, a physiological signal from the forehead used to stage sleep or respiratory effort signal obtained from an optional piezo respiratory effort belt can be acquired. The battery powered Unicorder provides sufficient capacity to record two nights of data. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required. A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger. Software, residing on a local PC or a physical or virtual server controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM. After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO2 and pulse rate. The actigraphy signals are transformed to obtain head movement and head position. A clinician can convert an auto-detected obstructive apnea to a central apnea based on visual inspection of the waveforms. ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES™ can also assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can help identify patients who would benefit from a laboratory PAP titration.

The provided FDA 510(k) summary for the Apnea Risk Evaluation System (ARES™), Model 610 (K112514) primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in a standalone performance evaluation. The changes in the modified device are related to software platform, improved filtering of the SpO2 signal, and new claims in the report messages.

Here's an attempt to extract and organize the information based on your request, with significant caveats that much of the requested detail is not explicitly provided in the document for the performance of the modified device in the way you've outlined:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily for the SpO2 accuracy after the filtering changes. The document explicitly states that the accuracy in all ranges is less than 3.5% as recommended by draft FDA guidance.

Note: The document states "The Arms has changed due to the filtering changes but labeling will reflect specification of < 3.0%. Accuracy in all ranges is less than 3.5% as recommended in Draft Guidance..." This implies < 3.0% is the target specification for labeling, and the performance meets the broader FDA guidance of < 3.5%.

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

The document mentions validation of the SpO2 filtering changes using "clinical data previously acquired in two clinical studies" but does not specify the sample size for these studies. The data provenance is described as "clinical data previously acquired," suggesting it was retrospective analysis of existing data. The country of origin is not specified.

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

This information is not provided in the document. For the new claims regarding treatment messages and PAP titration identification, it states these are "supported by published literature," but it doesn't detail the ground truth establishment process for this specific device's testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

A Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the document. The study described focuses on the device's SpO2 accuracy and the functionality of the new software platform and report messages.

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

A standalone performance evaluation of the algorithm's core diagnostic capabilities (e.g., apnea/hypopnea detection accuracy compared to PSG) is not detailed as a new clinical study for this 510(k) submission. The clinical tests mentioned specifically relate to the filtering changes to the SpO2 signal. The document states: "The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography," which implies standalone performance, but the K112514 document primarily refers back to the predicate device (K111194) for such claims and only describes validation of the SpO2 filtering for the current submission.

7. The Type of Ground Truth Used

For the SpO2 accuracy validation:

• Original breathe down data: This typically involves controlled desaturation events where arterial blood gas measurements or a highly accurate reference pulse oximeter serve as ground truth for SpO2.
• Breath hold data: This involves evaluating performance during dynamic SpO2 changes, again implying a reference standard for SpO2 measurements.
• For the new claims (treatment planning messages, PAP titration): The ground truth is cited as published literature.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "previously acquired clinical data" being used for validation, but not for training.

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

The document does not provide information on how ground truth was established for any training set for the modified device, as it primarily focuses on validating changes to an already cleared device.

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