Search Results

The Vermed A10021, is designed to be a single use disposable electrode for resting EKG cardiac evaluation procedures. This electrode is designed for infant, pediatric, and adult use. The maximum duration of use is 1 hour. These electrodes should be discarded after one use on the skin.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device (Vermed A10021 "Resting EKG Tab Electrode"). This document does NOT contain information about acceptance criteria, device performance studies, or details regarding the development and validation of an AI algorithm.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory requirements but provides no technical details about how the device's performance was evaluated or what specific criteria it met.

Therefore, I cannot fulfill your request for the following reasons:

1. Table of acceptance criteria and reported device performance: This information is not present in the document.
2. Sample size and data provenance for the test set: Not available.
3. Number and qualifications of experts for ground truth: Not available.
4. Adjudication method for the test set: Not applicable as no such study is described.
5. MRMC comparative effectiveness study: Not applicable, as this is a physical electrode, not an AI system.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 can be used for Sleep Studies, surface EMG, NCS and EP.

The Vermed A10005 electrode is designed to measure muscle activity from the surface of the skin. The A10005 electrode is provided in a NON-STERILE format only, and should be used on the surface of the skin.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Vermont Medical, Inc. for their "Multipurpose Neuroplus Electrode, Model A10005". This document primarily discusses the regulatory approval of the device and its intended use.

It does not contain any information about acceptance criteria for a study, nor does it describe a study that proves the device meets specific performance criteria. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed performance study report.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.

Ask a specific question about this device

Ask a specific question about this device