(70 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, 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 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 (SpQ2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO- 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 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.
Here's an analysis of the provided text regarding the ARES device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Study 1: Equivalence of ARES™ chest belt signals to predicate device (Compumedics Somté) in response to breathing events. | The ARES™ chest signal and Somté chest signal were equivalent in their response to three types of breathing events. The acceptance criteria of at least 95% waveforms being equivalent was met. The study result is Pass. |
| Clinical Study 2: Ability for users to properly apply the ARES™ with chest belt such that signals are useful for interpretation. | At least 95% of signals from the ARES effort belt recorded during overnight studies are interpretable and behave consistently based on the airflow signal. Based on subject feedback from a Usability survey, the Unicorder with effort belt can be easily used by patients. |
| Non-Clinical Testing: Compliance with system-level requirements. | All features of the ARES™ Model 610 were compliant with the system level requirements. |
| Non-Clinical Testing: Correct acquisition and storage of signals from a cleared respiratory effort belt. | The ARES Unicorder correctly acquires and stores the signal from a cleared respiratory effort belt. |
| Non-Clinical Testing: Signals acquired provide similar information for physician interpretation compared to the predicate device. | Signals acquired with the ARES™ Model 610 provide similar information as compared to the predicate device that would allow a physician, trained in sleep medicine to interpret the signals. Snapshots acquired from the new and predicate device provide similar information that would allow a physician, trained in sleep medicine, to interpret the signals. |
| Non-Clinical Testing: Conformity to electrical safety and electromagnetic compatibility standards. | Conformity to FDA recognized consensus standards and voluntary standards, including IEC 60601-1-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment - Part 1: General requirements for safety) and IEC 60601-1-2: 2007 (Electromagnetic compatibility - requirements and tests), was demonstrated. (No specific performance values for these are given, but compliance implies meeting the criteria within the standards). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Two clinical studies were conducted," but does not explicitly state the sample size for either clinical study.
The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). However, the description of clinical studies implies prospective data collection for the purpose of validating the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used to establish ground truth for the clinical studies.
It notes that the "signals acquired... would allow a physician, trained in sleep medicine to interpret the signals." This implies that the interpretation of signals for the "ground truth" or comparison in the equivalence study would be done by physicians trained in sleep medicine, but their specific qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For the first clinical study, it states the ARES chest signal and Somté chest signal were "equivalent in their response," implying a direct comparison rather than a consensus among multiple human readers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in this 510(k) summary. The clinical studies focused on signal equivalence and interpretability, not on the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document mentions that the ARES™ can "auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography" and that "A clinician can convert an auto-detected obstructive apnea to a central apnea based on visual inspection of the waveforms."
However, beyond these functional descriptions, the reported clinical studies primarily focus on signal acquisition, equivalence, and interpretability by a physician, rather than a standalone performance evaluation of the scoring algorithm's accuracy against a gold standard without human intervention. The statement "at least 95% of signals from the ARES effort belt recorded during overnight studies are interpretable and behave consistently based on the airflow signal" suggests a focus on the quality of the raw data for human interpretation, not the autonomous performance of an algorithm.
7. The Type of Ground Truth Used:
For the first clinical study (signal equivalence), the "ground truth" appears to be the signals simultaneously acquired using the predicate device, Compumedics Somté System. This functions as a form of comparative ground truth against an established device.
For the second clinical study (usability/interpretability), the ground truth for "interpretable and behave consistently" is implied to be expert visual assessment based on consistency with airflow signals by a physician trained in sleep medicine. Additionally, subject feedback from a Usability survey served as a form of ground truth for ease of use.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. This 510(k) summary focuses on the validation of modifications to an existing device (adding a respiratory effort belt) and demonstrating substantial equivalence, rather than the initial development and training of the core algorithmic components for apnea detection.
9. How the Ground Truth for the Training Set Was Established:
Since no training set information is provided, the method for establishing its ground truth is also not described.
§ 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).