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Intended for use in defibrillation procedures, cardioversion and pacing. This device is intended for use on adults and pediatric patients weighing over 10kg.

A pre-gelled conductive electrode consisting of a pre-attached leadwire, an insulating layer of a vinyl substrate, a layer of metal foil, a conductive adhesive hydrogel, a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch; 10 pouches are packaged into one shelf box shipper.

The provided text describes the 510(k) summary for the Medi-Trace® 1310P Combination Defibrillation, Monitoring and Pacing Electrode. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "the device and the predicate were subject to AAMI electrical tests" and "the device was subjected to simulated use testing." However, it does not specify the sample size for the test set used in any of these tests.

The data provenance is not explicitly stated, but the tests appear to be conducted by the manufacturer, Graphic Controls Corporation, in their facility (189 Van Rensselaer Street, Buffalo, NY). These are likely prospective tests conducted during the development and validation of the device. There is no information provided about countries of origin if external data were used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The performance evaluation relies on meeting specifications established in AAMI DF-39 and ISO-10993, which are standards-based, rather than relying on expert ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. The testing described is against established technical standards (DF-39) and biocompatibility standards (ISO-10993), not against adjudicated clinical observations or diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative AI systems where human readers evaluate cases. The Medi-Trace® 1310P is an electrode, and its performance is evaluated against physical and electrical standards, not human diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This concept is not applicable to this device. The Medi-Trace® 1310P is a medical device (electrode), not an algorithm or AI system. Its performance is inherent to its physical and electrical properties.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on pre-established engineering and biological standards:

• AAMI DF-39: This standard defines performance requirements for self-adhesive defibrillation and pacing electrodes.
• ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing: This standard provides guidelines for biocompatibility testing.
• Manufacturer-established specifications: Implicitly, the manufacturer sets internal specifications based on these standards.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided in the document. As this is not an AI/ML device, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable and therefore not provided in the document, as there is no training set for this device.

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