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The ECG Electrodes Apron is a reusable electrode system intended for use in rest ECG recording. The ECG Electrodes Apron is compatible for use with most ECG instruments on the market.

ECG Electrodes Apron is a system of ECG electrodes cast in a The hyper-flexible silicone apron The electrodes are gold-plated and the conductors are made of copper. The entire apron, including the conductors, is flexible and can be stretched to fit all body shapes and sizes, men and women alike. The apron is connected by a standard cable and is compatible with almost any type of commonly used ECG instrument.

The provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria through specific performance metrics.

Instead, the document primarily focuses on regulatory approval (510(k) summary) for the ECG Electrodes Apron. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on safety (biocompatibility) and effective performance, but without providing quantifiable acceptance criteria or detailed study results.

The key statement regarding performance is: "The effective performance of the ECG Electrodes Apron has been established through comparative testing with market-cleared devices." However, no details about this comparative testing are provided.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

Here's a breakdown of what is available (or explicitly NOT available) based on your requested points:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not specified in quantifiable terms.
   • Reported Device Performance: Stated as "effective performance... established through comparative testing with market-cleared devices," but no specific metrics or results are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not mentioned. (Ground truth establishment is not relevant as no specific performance study with a test set is detailed.)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

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: Not applicable. This device is an ECG electrode apron, 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: Not applicable. This is a hardware medical device (electrodes), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no detailed performance study is presented. The "effective performance" likely refers to signal quality comparable to predicate devices, but the method for assessing this "effectiveness" or "ground truth" for signal quality is not described.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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