(512 days)
Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and accessories. The recorder is designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as well as the patient information will be displayed and stored in the memory of the recorder. The information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis software. The analysis results are only used as advisory basis. The accessories contain disposable electrodes, cables, USB connecting line.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list acceptance criteria as quantitative thresholds for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "Automatic analysis function verification per AAMI EC 57" was performed, and that "The test results complied with FDA recognized standards and be evaluated to determine it was acceptable." This implies that the device's performance was judged against the requirements of the AAMI EC 57 standard for automated ECG analysis.
Acceptance Criteria (Implied from text):
- Compliance with IEC 60601-1:1988+A1:1991+A2:1995 (Electrical Safety Test)
- Compliance with IEC 60601-1-2:2001+A1:2004 (EMC Test)
- Compliance with IEC 60601-2-47:2001 (Performance Test)
- Compliance with ISO 10993 series standards (Biocompatibility Test)
- Compliance with AAMI EC 57 (Automatic analysis function verification)
Reported Device Performance:
The document states: "The test results complied with FDA recognized standards and be evaluated to determine it was acceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to the predicate device."
Table format (best effort given limited data):
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Electrical Safety) | Complied |
| IEC 60601-1-2 (EMC) | Complied |
| IEC 60601-2-47 (Performance) | Complied |
| ISO 10993 (Biocompatibility) | Complied |
| AAMI EC 57 (Auto Analysis) | Complied |
It is important to note that the specific quantitative performance metrics (e.g., beat detection accuracy, arrhythmia classification accuracy) required by AAMI EC 57 and the device's actual performance against those metrics are not provided in this summary. The summary only states that the device "complied."
Study Information
The document describes several tests conducted to establish the safety and effectiveness of the device, ultimately concluding substantial equivalence to a predicate device. However, it does not describe a specific clinical study or an algorithm-specific performance study with detailed methodology, sample sizes, and ground truth establishment in the way typically expected for AI/ML device submissions today.
The "Automatic analysis function verification per AAMI EC 57" is the closest mention of a performance evaluation relevant to the analytical components of the ECG system.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not specified. The document only mentions that the analysis results are for review by a "trained physician in health facilities." It does not detail who established the ground truth for the verification testing.
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Adjudication Method for the Test Set:
- Not specified.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC study is not mentioned. The document describes tests primarily related to electrical safety, EMC, performance against a standard (IEC 60601-2-47), biocompatibility, and automatic analysis verification per AAMI EC 57. There is no information about human reader performance or the effect of AI assistance on human readers.
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Standalone Performance Study (Algorithm Only):
- Yes, implicitly. The "Automatic analysis function verification per AAMI EC 57" suggests a standalone evaluation of the algorithm's performance against a recognized standard. However, the details of this evaluation (e.g., specific metrics, dataset) are not provided beyond the statement of compliance.
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Type of Ground Truth Used:
- For "Automatic analysis function verification per AAMI EC 57," the ground truth would typically be established by expert review (e.g., cardiologists, electrophysiologists) of the ECG recordings, but this is not explicitly stated or detailed in the document. It is implied by the standard itself.
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Sample Size for the Training Set:
- Not specified. The document does not describe the development or training of an AI/ML algorithm, or any associated training data. It refers to an "analysis software" with "automatic analysis function."
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How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as information about a training set or algorithm development is not provided.
§ 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).