(87 days)
The Audicor 200 System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated report for consideration by physicians. In addition, the Audicor 200 System can be used with an add-on laptop computer that allows data to be presented in the format of real-time and trended display of advanced parameters derived from simultaneous ECG data and heart sounds data.
The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device is intended for use only under the direct supervision of a physician, and is for use on adults (>= 18 years).
The Audicor 200 is a stand-alone device that can be used to capture 10-second evaluations of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome. In addition the system can be connected to a compatible laptop computer and used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.
The provided text is a 510(k) summary for the "SDI Modification to AUDICOR 200 System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance metrics for a novel algorithm.
Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is largely not present within the provided document. The submission references compliance with performance standards for medical electrical equipment (AAMI EC-11, EN 60601-1, etc.), which are general safety and performance standards for electrocardiographs, not specific performance metrics for the SDI algorithm or its interpretive statements.
However, I can extract and infer some related information:
Description of the Device and its New Features
The "SDI Modification to AUDICOR 200 System" adds a new parameter, the Systolic Dysfunction Index (SDI), and associated interpretive statements. These statements are:
- "Prolonged EMAT, consider LV systolic dysfunction"
- "Consider LV systolic dysfunction [reason block]"
- "Consider severe LV systolic dysfunction with diastolic dysfunction [reason block]"
- "Consider elevated LV filling pressure"
- "S3 detected -consider acute heart failure in presence of dyspnea"
These statements are only for patients over 40 years of age.
The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (AUDICOR® 200 system K043074, with Audicor Advanced Parameters K051450). It states that the new device and the predicate are "technologically equivalent" in their ability to acquire and display ECG and heart sound data, and analyze "Advanced Parameters."
Addressing Your Specific Questions based on the Provided Text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics for the SDI modification. The document indicates compliance with general medical device standards (AAMI EC-11, EN 60601-1, IEC 60601-2-25) related to electrocardiograph safety and performance, which are not specific to the diagnostic accuracy of the new SDI parameter or interpretive statements.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, AUC) for the SDI or its interpretive statements are provided. The only "performance" discussed is compliance with the aforementioned general safety and device standards.
Table (Based on Inference - No Specific AI Performance Metrics Found):
| Acceptance Criterion (Inferred from 510(k) focus) | Reported Device Performance |
|---|---|
| Compliance with AAMI EC-11 (Diagnostic Electrocardiographic Devices) | The Audicor 200 System has been tested and shown to comply. |
| Compliance with EN 60601-1 (Medical Electrical Equipment: General Requirements for Safety) | The Audicor 200 System has been tested and shown to comply. |
| Compliance with EN 60601-1-2 (EMC Requirements) | The Audicor 200 System has been tested and shown to comply. |
| Compliance with IEC 60601-2-25 (Particular requirement for safety of electrocardiographs) | The Audicor 200 System has been tested and shown to comply. |
| Substantial Equivalence to Predicate Device (AUDICOR® 200 system K043074, with K051450 Advanced Parameters) | Device determined to be substantially equivalent based on technological characteristics and intended use. |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. 510(k) summaries for modifications of existing devices often rely on the predicate device's data or general engineering tests rather than new clinical trials with specified test sets for performance of new algorithms.
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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):
- This information is not provided. As no specific clinical test set for the SDI algorithm's performance is detailed, the method of establishing ground truth is not described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided.
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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 MRMC comparative effectiveness study is mentioned. The device's interpretive statements are "for consideration by physicians" and "are only significant when used in conjunction with physician over read," indicating the device is intended as an aid, but no study on physician improvement with this aid is presented.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance study for the SDI or its interpretive statements is not described. The document explicitly states the interpretations "are only significant when used in conjunction with physician over read."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not provided.
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The sample size for the training set:
- This information is not provided. The document describes a "modification" to an existing system, implying the underlying algorithms were likely developed and validated prior to this specific submission, or that the new SDI parameter was developed based on existing clinical understanding rather than a large-scale machine learning training effort documented here.
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How the ground truth for the training set was established:
- This information is not provided.
In conclusion, this 510(k) summary focuses on demonstrating the safety and technological equivalence of a device modification (adding an SDI parameter and interpretive statements) to a previously cleared predicate device, rather than providing detailed clinical performance data for a new AI algorithm. It adheres to general device standards but does not offer specific acceptance criteria or study results for the diagnostic accuracy of the new features.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).