(31 days)
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, airflow, and a physiological signal from the forehead used to stage sleep. 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 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. 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. ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES can assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can also help identify patients who would benefit from a laboratory PAP titration.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (ARES™ Model 610) |
|---|---|
| Electrical and Biological Safety | Conforms to IEC 60601-1-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment – Part 1: General requirements for safety) |
| Electromagnetic Compatibility | Conforms to IEC 60601-1-2: 2007 (Medical Electrical Equipment Part 1–2: Collateral standard: Electromagnetic compatibility – requirements and tests) |
| Biocompatibility | Conforms to ISO 10993-1: 2009 (Biological evaluation of medical devices Part 1) |
| Cleaning Reusable Medical Devices | Conforms to ISO AAMI TIR 30: 2003 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) |
| Reprocessing in Healthcare Facilities | Conforms to ISO AAMI TIR 12: 2010 (Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical manufacturers) |
| Hardware and Firmware Functionality | Hardware and firmware met system requirements |
| System Level Requirements Compliance | All features of Model 610 were compliant with system level requirements |
| Equivalent Signal Quality (stabilizing strap and enclosure pad) compared to predicate device | Demonstrated equivalent performance to Model 600 in terms of comfort and pressure applied to the forehead sensor. |
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Tests: 14 subjects.
- Number of Overnight Sleep Studies: 20.
- Data Provenance: Not explicitly stated, but the study was conducted to compare the new model to the predicate, implying it was likely a prospective study undertaken specifically for this submission. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. The study focused on comparing the performance of the stabilizing strap and enclosure pad of the ARES™ Model 610 to the ARES™ Model 600 regarding signal quality, comfort, and pressure. It appears to be a technical comparison rather than a diagnostic accuracy study requiring expert-established ground truth for medical outcomes.
4. Adjudication method for the test set
Not applicable. The clinical study was a direct comparison of physical components (stabilizing strap and enclosure pad) between two device models, focusing on comfort and pressure applied, rather than a diagnostic accuracy study that would typically involve adjudication of diagnostic outcomes.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a modified version of an existing device (ARES™ Model 610 vs. ARES™ Model 600) and focused on demonstrating equivalent performance of physical components and compliance with safety and performance standards, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly state that a standalone (algorithm only) performance study was conducted. The main clinical study focused on the physical components of the device (stabilizing strap and enclosure pad) and ensuring equivalent signal quality and comfort compared to the predicate device. The ARES™ Insight software processes sleep study data and auto-detects events, which implies an algorithm, but a standalone performance study with metrics like sensitivity/specificity for these detections (separate from the physical modifications) is not detailed in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical study described, the "ground truth" was related to the equivalent signal quality, comfort, and pressure applied to the forehead sensor as compared to the predicate device. This was likely assessed via subjective feedback (comfort) and objective measurements of signal quality, with the predicate device (Model 600) serving as the reference for equivalence. It wasn't about diagnostic accuracy for sleep apnea via expert consensus, pathology, or outcomes data in this specific submission.
8. The sample size for the training set
The document does not mention the sample size for a training set. This submission is for a modification of an existing device, and the testing described is primarily for demonstrating equivalence and compliance with standards for the modified hardware, not for developing or training a new algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set or its ground truth establishment is described in this submission.
§ 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).