(153 days)
The Apnea Risk Evaluation System (ARES™) 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, airflow, respiratory effort, and a physiological signal from the forehead used to stage sleep. The battery-powered Unicorder provides sufficient capacity to record for 18-hours of continuous use. 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 controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. Algorithms are applied to the physiological data to automatically detect apneas and hypopneas, distinguish sleep from awake and rapid eye movement sleep from non-rapid eye movement sleep. A full disclosure recording is provided, allowing a clinician to edit any of the events detection algorithms. The software includes the capability to assign a pre-test probability of a patient having OSA based on questionnaire responses. Six disposable components must be replaced and the forehead sensor must be cleaned before reuse.
The provided text describes the Apnea Risk Evaluation System (ARES) Model 600. It details various performance tests conducted to establish substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or an explicit study that quantifies device performance against those criteria in a table format with numerical results.
However, based on the text, we can infer some aspects related to acceptance criteria and the nature of the validation.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of acceptance criteria with corresponding performance metrics. Instead, it indicates that "Design verification and validation tests were performed on the ARES Unicorder Model 600 to ensure it meets the specified product requirements," and states that the accuracy of automated detection was "assessed and compared to the predicate device." This phrasing suggests a comparative approach to acceptance rather than pre-defined numerical thresholds.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety | Conformity to IEC 60601-1 and related standards | Achieved (supported by "risk analysis" and "extensive testing") |
| Software | Conformity to FDA Guidance for Software in Medical Devices | Achieved (listed as a performance test item) |
| Head Position/Movement Measurement | Equivalence to ARES Model 500 (predicate) | Achieved ("bench comparison report") |
| Airflow, Respiratory Effort, Pulse Rate, SpO2 Measurement | Equivalence to ARES Model 500 (predicate) | Achieved ("channel/signal comparisons") |
| EEG, EOG, EMG Measurement | Equivalence to Sandman Digital (predicate) | Achieved ("channel/signal comparisons") |
| Accuracy of Automated Detection (Awake, Sleep, REM vs. non-REM) | Comparable to predicate device's performance against technician scoring (gold-standard) | "Accuracy... was assessed and compared to the predicate device." (No specific metrics provided in this document). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for performance evaluation of automated detection. It mentions "laboratory PSG" as the gold standard, suggesting the data originated from sleep lab studies. The provenance (country of origin) is not specified, but the submission is to the US FDA, so it's likely US data. The data appears to be retrospective, as it's used for comparison against technician scoring.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document states that "The technician scoring was considered the gold-standard for purposes of assessing accuracy."
- Number of experts: Not specified (implied to be one or more technicians per PSG).
- Qualifications of experts: "Technician scoring" implies trained polysomnography technicians. No specific experience level (e.g., "10 years of experience") is mentioned.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. The ground truth for automated detection was based on "technician scoring," which implies a single-reader assessment per PSG record, rather than a consensus or adjudicated reading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not described. The documentation focuses on the device's standalone performance compared to technician scoring and other predicate devices, not on human readers' improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The document states: "The accuracy of the automated detection of awake and sleep and REM vs. non-REM compared to technician scoring of laboratory PSG was assessed and compared to the predicate device." This directly refers to the algorithm's performance without human intervention.
7. The Type of Ground Truth Used
The ground truth used for assessing the automated detection of sleep stages (awake, sleep, REM vs. non-REM) was expert consensus / technician scoring (specifically stated as "technician scoring of laboratory PSG was considered the gold-standard").
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size of a training set for the algorithm. It focuses on the validation of the ARES Model 600, not its development.
9. How the Ground Truth for the Training Set Was Established
Since no information regarding a training set is provided, there is also no information on how its ground truth was established.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).