(286 days)
The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.
The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way described in the prompt's request. The document is a 510(k) summary for a 12-Lead Simultaneous Cable, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed metrics against pre-defined acceptance criteria.
However, I can extract the available information and highlight what is missing based on your request.
Missing Information:
The provided text does not include the following details that are typically found in a detailed performance study:
- A table of specific acceptance criteria (e.g., signal-to-noise ratio, frequency response, accuracy of parameter measurements).
- Reported device performance against those specific criteria.
- Sample size used for a test set (beyond "non-clinical testing").
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of AI assistance on human readers.
- Specific details of a standalone (algorithm only) performance study.
- The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Based on the available text, here's what can be inferred/extracted:
1. A table of acceptance criteria and the reported device performance:
The document states: "Non-clinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device."
- Acceptance Criteria (Inferred): Substantial equivalence to the predicate device (MAX 1 Exercise Testing System) regarding its function of acquiring and transmitting ECG signals. The specific quantitative criteria for this equivalence are not detailed.
- Reported Device Performance: The device was found to be "substantially equivalent" to the predicate device. No specific numerical performance metrics are provided.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document only mentions "Non-clinical testing."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific human expert review for establishing ground truth is mentioned for performance evaluation. The comparison is against a predicate device's expected performance.
4. Adjudication method for the test set:
- Not applicable/Not specified, as no human expert review process 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, this type of study was not mentioned. The device is a cable for acquiring and transmitting ECG signals, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a physical cable. Its "performance" would be related to signal integrity and transmission accuracy, which were presumably assessed in non-clinical standalone tests, but details are not provided. There's no AI algorithm involved.
7. The type of ground truth used:
- The ground truth implicitly used is the performance of the legally marketed predicate device (MAX 1 Exercise Testing System), against which the new device demonstrated "substantial equivalence." The specific metrics from the predicate device that served as ground truth are not detailed.
8. The sample size for the training set:
- Not applicable. The device is a physical cable, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).