(267 days)
The AccurECG Analysis System is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.
The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG Analysis System is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).
The AccurECG Analysis System is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.
The AccurECG Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.
The AccurECG Analysis System does not interface with data management systems or hardware and is device independent.
The AccurECG Analysis System ("AccurECG" or the "System") consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.
AccurECG is intended to analyze recordings performed on adults over the age of 22 and works in the following sequence:
- i. The web interface allows the user to select files and upload to the AccurECG secure database.
- ii. The proprietary AccurECG algorithm analyzes and labels the ECG:
- o Delineation detection of ORS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
- · Abnormality labels automated arrhythmia interpretation and statistical classification.
- iii. AccurECG Analysis System displays the resulting analysis and original ECG signal with reviewing tools in the web interface.
- iv. AccurECG Analysis System allows for preliminary comments summarizing the review before generating a report.
Here's a summary of the acceptance criteria and the study details for the AccurECG® Analysis System, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for specific metrics (e.g., sensitivity, specificity, accuracy). However, it indicates that performance tests were conducted in conformance with specific FDA-recognized consensus standards. The "Summary of Performance Data" section implies that the device met the requirements of these standards without detailing specific quantitative metrics.
The standards mentioned are:
- AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
- IEC 60601-2-47:2012 Medical Electrical Equipment, Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems (Section 201.12.1.101 -Algorithm Testing).
The "Conclusion" section states, "Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the AccurECG® Analysis System has been shown to be substantially equivalent to the cited predicate." This indicates that the device's performance, as evaluated against these standards, was deemed sufficient for substantial equivalence.
Without specific performance metrics from the document, a table of acceptance criteria and reported device performance cannot be fully constructed.
Study Details
The document provides limited information regarding the specifics of the performance study.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The document mentions "clinical input requirements were validated against a gold standard," which implies a dataset, but details on its origin (e.g., country, retrospective/prospective) are absent.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document refers to "gold standard" but doesn't specify how this was established or by whom.
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Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. The mention of "gold standard" suggests a defined ground truth, but the method (e.g., 2+1, 3+1 consensus) is not described.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any evaluation of human readers with vs. without AI assistance. The focus seems to be on the standalone performance of the algorithm against standards and a "gold standard."
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: Yes, a standalone performance evaluation of the algorithm was done. The "Summary of Performance Data" refers to performance tests "in conformance with the following FDA-recognized consensus standards" and "All clinical input requirements were validated against a gold standard." This indicates an assessment of the algorithm's capabilities without direct human-in-the-loop interaction for performance measurement. The "Software verification and validation" section also notes verification and validation tests.
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The Type of Ground Truth Used:
- Ground Truth Type: "Gold standard." The specific nature of this "gold standard" (e.g., expert consensus on ECGs, pathology, outcomes data) is not detailed. However, given the context of ECG analysis, it would typically involve expert-annotated ECG waveforms.
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The Sample Size for the Training Set:
- Training Set Sample Size: Not explicitly stated. The document focuses on the validation aspect and does not provide details about the training data used for the algorithm.
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How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth Establishment: Not explicitly stated. This information is typically proprietary to the developer's methodology and is often not fully disclosed in 510(k) summaries.
§ 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).