(213 days)
The AUDICOR System when used with an AUDICOR Sensor 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, body position, 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 Hemo ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sounds, body position, 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 l
- . Heart rate variability
- Snoring detection .
- Sleep disordered breathing (apnealhypopnea) events
- . Sleep disordered breathing score
- Activity level .
- . Body position
- 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.
The AUDICOR System has two primary components for which clinical performance testing was conducted: "Body Position" and "Single Sensor Heart Sound."
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for either the Body Position or Single Sensor Heart Sound studies. Instead, it relies on demonstrating substantial equivalence to predicate devices.
Body Position:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy equivalent to limits achievable by predicate technology. | "The results of this study conclusively shows AUDICOR performance to be equivalent to the limits achievable using the same technology employed by the predicate device." |
| Performance substantially equivalent to the predicate device. | "Evaluation of performance metrics effectively demonstrates performance that is substantially equivalent to the predicate device." (Predicate: VivoMetrics LifeShirt with VivoLogic Analysis Software) |
Single Sensor Heart Sound:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Statistically equivalent performance to the two-sensor system. | "The results of the study show that AUDICOR heart sound algorithms modified for use with a single sensor have statistically equivalent performance as that of the two-sensor system." (Predicate: AUDICOR two-sensor system, the previously cleared AUDICOR CPAM) |
2. Sample Size and Data Provenance
- Body Position: "a group of subjects representative of those intended to use the device." No specific number is provided. The study was retrospective. No country of origin is explicitly stated, but given the FDA submission, it's likely US-based or compliant with US standards.
- Single Sensor Heart Sound: "reemployed datasets initially used for obtaining FDA clearance for the two-sensor system on a group of patients representative of those the device is intended for." No specific number is provided. The study was retrospective. No country of origin is explicitly stated, but similar to the Body Position study, likely US-based.
3. Number and Qualifications of Experts for Ground Truth
The document does not provide information on the number or qualifications of experts used to establish ground truth for either the Body Position or Single Sensor Heart Sound studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for establishing ground truth in the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The studies focus on device performance against a "gold standard" or a predicate device, not on how human readers improve with AI assistance.
6. Standalone (Algorithm Only) Performance
The studies described are standalone (algorithm only) performance evaluations.
- For Body Position, the AUDICOR "automated signal processing algorithm" processes accelerometer signals to determine body position, which is then compared to a "gold-standard performance."
- For Single Sensor Heart Sound, the "AUDICOR heart sound algorithms modified for use with a single sensor" are evaluated for their performance compared to the two-sensor system.
7. Type of Ground Truth Used
- Body Position: The document mentions "idealized gold-standard performance" for body position accuracy, but it doesn't specify how this gold standard was established (e.g., manual observation, another validated device, expert annotation). Given the reliance on accelerometer signals, it's likely a comparison to a highly accurate reference system for body position.
- Single Sensor Heart Sound: The ground truth for the comparison was the performance of the predicate two-sensor AUDICOR system. The study aimed to show "statistical equivalency" to this established system.
8. Sample Size for the Training Set
The document does not provide specific sample sizes for the training sets for either the Body Position algorithm or the Single Sensor Heart Sound algorithm. It mentions "retrospective clinical tests" were performed and "reemployed datasets" for the heart sound study, which implies existing data was used, potentially for training and/or testing.
9. How the Ground Truth for the Training Set was Established
The document does not explicitly describe how the ground truth for any training set was established. Given the retrospective nature of the studies and the comparison to a predicate device, it's plausible that the ground truth for training (if separate from testing) would have also been derived from established clinical data or the performance of the prior AUDICOR system.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).