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Skintact ECG Electrodes are designed for use in general electrocardioaraphic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Skintact ECG Electrodes are single use, non-sterile and disposable and are to be used on intact (uninjured) skin.

All Skintact® ECG Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® Pre-wired ECG Electrodes with Conductive Adhesive are composed of the same materials as the predicate devices by Leonhard Lang except the pre-attached lead wire. The lead wires are similar to those in predicate devices.

This 510(k) submission is for a modification to an existing device, the Skintact® Pre-wired ECG Electrodes with Conductive Adhesive. The primary change is the addition of a pre-attached lead wire to an already cleared ECG electrode. As such, the submission focuses on demonstrating that this modification does not introduce new issues of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission (a modification to an existing device, primarily adding a pre-attached lead wire), the acceptance criteria generally revolve around demonstrating that the new feature (pre-attached lead wire) and the overall device performance meet established standards for ECG electrodes.

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

The provided document does not explicitly state specific sample sizes for the performance tests (biocompatibility, ANSI/AAMI EC12:2000, shelf life). It refers to the tests being conducted and meeting standards, implying that sufficient samples were used to generate statistically meaningful results in line with the standards' requirements.

The data provenance is not explicitly stated regarding country of origin or retrospective/prospective nature for these specific tests. However, given the submitting company (Leonhard Lang GmbH) is based in Austria, it's reasonable to infer that some testing might have been conducted in Europe. The reference to FDA-recognized standards (ANSI/AAMI EC12:2000 and ISO 10993) indicates adherence to internationally accepted methodologies.

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

This type of information is not applicable to this 510(k) submission. The device is a medical accessory (ECG electrode) and the performance testing described (biocompatibility, electrical/mechanical performance, shelf life) relies on objective measurements against established engineering and safety standards (ISO 10993, ANSI/AAMI EC12:2000). There is no "ground truth" in the clinical diagnostic sense that would require expert consensus for these particular tests.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable here. Adjudication methods are typically employed in clinical trials or studies where subjective assessments by multiple experts need to be resolved to establish a definitive "ground truth" (e.g., in image interpretation studies). The performance tests mentioned in this submission are objective laboratory tests against pre-defined specifications.

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 relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to assess improvements in reader performance with or without AI assistance. The Skintact® Pre-wired ECG Electrodes are not a diagnostic imaging device, nor do they involve AI assistance or human interpretation in their intended use.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This concept is specifically applicable to AI/ML software as a medical device (SaMD) where the algorithm's performance is assessed independently of human intervention. The Skintact® Pre-wired ECG Electrodes are a physical medical device (an electrode), not a software algorithm.

7. The Type of Ground Truth Used

For the performance tests mentioned:

• Biocompatibility: The "ground truth" is adherence to the criteria outlined in ISO 10993. This involves laboratory tests to detect potential cytotoxic, irritation, or sensitization effects.
• ECG Electrode Performance: The "ground truth" is meeting the technical specifications and criteria defined in the ANSI/AAMI EC12:2000 standard. This involves objective measurements of electrical and mechanical properties in a laboratory setting.
• Shelf Life: The "ground truth" is stability over time, demonstrated by maintaining performance (e.g., adhesion, electrical properties) after accelerated aging that simulates real-time aging, according to established test protocols.

These are all objective, laboratory-based performance benchmarks against recognized standards, rather than clinical outcomes or pathology data.

8. The Sample Size for the Training Set

Not applicable. This submission is for an ECG electrode, which is a hardware medical device. It does not involve any artificial intelligence (AI) or machine learning (ML) models that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment process for a training set.

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