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510(k) Data Aggregation
(106 days)
The vicardio is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.
The vicardio is a digital, PC-based electrocardiograph with a special isolation amplifier between the patient and the computer.
The provided documentation for the 'vicardio 12b' electrocardiograph does not include specific acceptance criteria or a detailed study proving the device meets performance criteria beyond non-clinical testing. It states that clinical tests were not required.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical tests: The device will have passed AAMI/ANSI EC11 tests. | The software has been extensively validated and tested. The device will have passed AAMI/ANSI EC11 tests. |
| Clinical tests: (Not explicitly stated, but the submission implies basic functionality and safety for intended use based on predicate device equivalence). | Clinical tests were not required. |
| Safety and Efficacy: Equivalent to legally marketed predicate devices. | The vicardio is equivalent in safety and efficacy to the legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No clinical test set or data from a clinical study is mentioned for evaluating performance against acceptance criteria.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is described.
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
- No. An MRMC comparative effectiveness study was not done. The device is a digital electrocardiograph for recording and measuring ECGs, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the device (vicardio 12b) itself is a standalone electrocardiograph without human-in-the-loop AI assistance for diagnostic interpretation. Its performance is related to its ability to accurately record and measure ECGs, for which non-clinical tests (AAMI/ANSI EC11) suffice. The concept of "algorithm only" or "standalone" performance for an AI model doesn't directly apply here, as it's a hardware/software system for data acquisition and basic measurement, not an AI-driven interpretive algorithm with a diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (AAMI/ANSI EC11), the ground truth would be established by the technical standards themselves, measured against known electrical signals and predefined performance benchmarks for ECG recording equipment. This is a technical, rather than a clinical or diagnostic, ground truth.
8. The sample size for the training set
- Not applicable. The document does not describe the development of an AI model that would require a "training set" in the context of machine learning. The "software ... extensively validated and tested" likely refers to traditional software engineering validation and verification processes.
9. How the ground truth for the training set was established
- Not applicable, as no training set for an AI model is described.
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