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Skintact® Multifunction Electrodes are for use on adults and children weighing more than 25 kg for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and single use only.

Skintact® Multifunction Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin. Skintact® Multifunction Electrodes are accessories to defibrillators. Skintact® Multifunction Electrodes are passive devices and do not contain active electronics, software or firmware.

Skintact® Multifunction Electrodes consist of a backing material, conductive layer and conductive adhesive gel. The Multifunction Electrodes are applied on a release liner. This is the same composition like used for devices approved in existing K072233.

The shape of the electrodes has been slightly modified in comparison with K072233. The difference in shape of electrodes is an enhanced total area, but the active area is equivalent like approved in existing K072233.

Also this submission adds additional models of multifunction electrodes compatible with additional models of defibrillators.

An additional type of packaging is offered. This type of packaging is substantially equivalent to reference device approved in existing 510(k) K082090 9131 Defibrillation Electrodes, Cardiac Science Corporation, decision date: 12/12/2008.

This document is a 510(k) summary for the Skintact® Multifunction Electrodes. It describes the device and its intended use, and argues for its substantial equivalence to previously cleared devices. It is a submission to the FDA, not a study report, and therefore does not contain the detailed study information requested in the prompt.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• This is a 510(k) submission, not a study report. A 510(k) demonstrates substantial equivalence to a predicate device, often through a combination of comparisons to existing devices, design verification, and some performance testing. It is not generally a study designed to "prove" a device meets acceptance criteria in the same way a clinical trial or a formal comparative effectiveness study would.
• The device is "passive" and an "accessory." The Skintact® Multifunction Electrodes are described as passive devices without active electronics, software, or firmware. This means the performance evaluation focuses on physical and electrical characteristics as an accessory, rather than complex algorithm performance.
• Focus on Substantial Equivalence: The primary objective of this document is to establish substantial equivalence to predicate devices (K072233 and K082090). Therefore, the "acceptance criteria" discussed are largely related to meeting the performance characteristics of those predicates and relevant safety standards.

Despite these limitations, I can extract and infer some information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. This document only states that "Performance testing was conducted" and "Biocompatibility testing has been performed." It does not provide details on the number of electrodes or test subjects used.
• Data Provenance: Not specified. The submission is from Leonhard Lang GmbH, based in Innsbruck, Austria. The testing would likely have been conducted in a laboratory setting, but specifics are not provided. It is not mentioned whether it was retrospective or prospective data.

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)

This information is not applicable and not provided. The testing described is for the physical and electrical performance and biocompatibility of a medical device accessory, not the interpretative accuracy of an AI or diagnostic tool. Ground truth in this context would be established by laboratory measurements against defined standards, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used when human interpretation or judgment is involved in establishing a ground truth (e.g., in reading medical images), which is not the case for the type of device testing described here.

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, an MRMC comparative effectiveness study was not done. This device is a passive accessory (electrodes) for a defibrillator, not an AI-powered diagnostic or interpretive tool that would assist human readers.

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

No, this question is not applicable. The device is a physical electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be:

• Physical measurements against established engineering standards: For electrical impedance, adhesion strength, and physical dimensions.
• Biocompatibility test results: Against ISO standards or other recognized guidelines for biological safety.
• Functional tests with compatible defibrillators: To ensure proper signal transmission and energy delivery.

This is fundamentally different from a clinical ground truth for a diagnostic device.

8. The sample size for the training set

Not applicable. This device is a passive medical accessory, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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