(218 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 and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing 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.
Subjects screened for sleep disordered breathing 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 CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide 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.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. It primarily describes the device, its intended use, and states that it complies with certain standards. There is no information on sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Here's a breakdown of what could be extracted and what is missing, based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in measurable terms (e.g., sensitivity, specificity thresholds). The document mentions compliance with standards (EN 60601-1, EN 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57) which likely contain performance requirements, but these are not detailed here. For the sleep disordered breathing analysis, it states it's intended "as a screening device...to determine the need for evaluation by polysomnography based on the patient's score," which implies a screening performance standard, but none is provided.
- Reported Device Performance: Not reported in quantitative terms (e.g., specific sensitivity, specificity, accuracy values for any of the detected parameters).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
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
- MRMC Study: Not mentioned. The document primarily focuses on the device's technical specifications and equivalency to predicates, not its impact on human reader performance.
- Effect Size: Not applicable as no MRMC study is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies a standalone algorithm performance for features like sleep disordered breathing detection as it mentions "analysis and reporting" and "interpretation of the data in an integrated report for consideration by physicians," suggesting the algorithm generates an interpretation before physician review. However, specific performance metrics for this standalone functionality are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For sleep disordered breathing, it implies comparison to polysomnography ("screening device to determine the need for evaluation by polysomnography"), which would likely be the ground truth for that specific function, but this is not confirmed.
8. The sample size for the training set
- Sample Size: Not mentioned.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not mentioned.
In summary, the provided text from the 510(k) K120462 document is a submission for a medical device modification (AUDICOR System - CPAM with SDB). It details the device's capabilities, intended use, and declares substantial equivalence to predicate devices, along with compliance with relevant safety and performance standards. However, it does not include the detailed study design, acceptance criteria, test set specifics, or performance metrics that would be necessary to populate the requested table and answer the study-related questions. Such information would typically be found in more detailed technical reports or clinical study summaries, which are not part of this "Summary of Safety and Effectiveness."
§ 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).