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CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.

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The provided document is a 510(k) clearance letter from the FDA for a device called "ECG Minimonitor, Model CG-5000." This type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical trials or detailed performance studies that would be necessary to define acceptance criteria and prove adherence for an AI/ML medical device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not available.
4. Adjudication method: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available.
6. If a standalone performance (algorithm only) study was done: Not available.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications For Use": "CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis."

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