(290 days)
The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.
The AUDICOR System employs the AUDICOR AM (Home) ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sound, sleep-disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician.
The AUDICOR System analyzes and reports the following parameters:
- Heart rate including bradycardia and tachycardia events .
- Atrial fibrillation .
- ECG beat classification and morphology grouping with user-editing .
- Heart rate variability .
- . Snoring detection
- . Sleep disordered breathing (apnea/hypopnea) events
- . Sleep disordered breathing score
- Activity level .
- Heart sound and combined ECG/heart sound measurements .
- Heart rate distributions of heart sound parameters .
The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.
Here's a breakdown of the acceptance criteria and study details for the AUDICOR System - CPAM with SDB (Accelerometer Based), based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary states that the study demonstrates the "substantial equivalence of the subject device's algorithm performance to that of the predicate device" regarding SDB detection. This implies that the acceptance criterion was likely to show a statistically equivalent or non-inferior performance compared to the previously cleared predicate device (K120462).
The exact performance metrics (e.g., sensitivity, specificity, accuracy) and specific thresholds for acceptance are not explicitly listed as quantitative acceptance criteria in the provided text. Instead, the focus is on a comparative statistical analysis.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| SDB detection performance is substantially equivalent to the predicate device (K120462). | "Substantial equivalence of the subject device's algorithm performance to that of the predicate device was demonstrated through this statistical comparison." The subject device's accelerometer-based SDB algorithm was found to be statistically equivalent in performance to the predicate device's ECG-based SDB algorithm. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 77 recordings
- Data Provenance: Prospective clinical testing conducted at Taipei Veterans General Hospital in Taipei, Taiwan.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. It mentions "Physician-overread results from concurrent polysomnography recordings" as the clinical gold standard. This implies that medical professionals (likely sleep physicians or trained polysomnography technologists) were involved in interpreting the PSG data to determine SDB positive and negative cohorts.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. It only mentions "Physician-overread results from concurrent polysomnography recordings" for establishing the clinical gold standard. It does not detail if multiple physicians reviewed, if there was a consensus process, or if a single reading was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on comparing the algorithm's performance (subject device vs. predicate device) against a clinical gold standard (physician-overread PSG), not on how human readers improve with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The study compared the "AUDICOR SDB detection performance of the predicate device (K120462) to that of the subject device" using their respective algorithms applied to concurrent data. This directly assesses the algorithm's performance without human intervention in the SDB detection process itself.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus / physician-overread polysomnography (PSG) results. Specifically, "Physician-overread results from concurrent polysomnography recordings on the test subjects was the clinical gold-standard used for establishing PSG-AHI positive and PSG-AHI negative cohorts."
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It only mentions the "test set of 77 recordings." The study appears to be an evaluation of an already developed algorithm, not the training process itself.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as it focuses on the evaluation (test) phase of the device's modification.
§ 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).