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Skintact ECG electrodes are designed for use in general electrocardiographic 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 non-sterile and are to be used on intact (uninjured) skin.

Skintact® ECG Electrodes (and as also to be offered for sale under various private label tradenames) will be offered with KS 01 solid wet gel. Just like the OR liguid gel electrodes, KS 01 solid wet gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The KS 01 solid wet gel electrodes are identical in size, shape and configuration to the QR liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using OR liguid gel conducting media.

The provided text describes the acceptance criteria and the studies performed for the Skintact® ECG Electrodes with KS 01 solid wet gel.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for specific tests.
  • Biocompatibility tests: Implied N/A as these are material-level tests, likely conducted on samples of the material, not on human subjects.
  • Electrical tests: Also implied N/A as these are device performance tests under laboratory conditions.
  • Shelf-life tests: Implied N/A as these are laboratory aging tests.
  • Clinical trace testing: Not explicitly stated.
  • Wear test reports: "Three wear test reports" were provided, implying a small number of volunteers. The exact number of participants per report is not given.
• Data Provenance: Not explicitly stated. However, the manufacturer is Leonhard Lang GmbH, located in Innsbruck, Austria, suggesting the studies were likely conducted in Austria or Europe.
• Retrospective or Prospective: Not explicitly stated; however, clinical trace testing and wear tests are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Trace Testing and Wear Tests: "A physician" reviewed the performance of the wear tests and examined for skin irritation. No specific qualifications (e.g., years of experience, specialty) for this physician are provided.
• Other tests: Ground truth for electrical and biocompatibility tests is based on adherence to a recognized standard (ANSI/AAMI EC 12:2000) or laboratory protocols, not expert consensus in the form described for clinical data.

4. Adjudication Method

• For wear tests: A single physician reviewed the performance and examined for skin irritation. This implies a "none" or "single expert" adjudication method without consensus or independent review processes mentioned.
• For clinical trace testing: The comparison was made between the new and predicate electrodes, and it was "determined that the KS 01 solid wet gel performs the same." The method of this determination (e.g., visual inspection by an expert, quantitative comparison) is not elaborated, so no specific adjudication method is described beyond comparison.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study in this submission. The studies focus on demonstrating equivalence to a predicate device and adherence to a standard, not on comparing human reader performance with and without AI assistance. The device is an ECG electrode, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable. The device is an ECG electrode, which is a physical medical device for signal acquisition, not a software algorithm that performs diagnostics independently. Therefore, a "standalone algorithm performance" study as typically understood for AI/ML devices was not performed.

7. Type of Ground Truth Used

• Biocompatibility: Laboratory test results conforming to established protocols (cytotoxicity, skin irritation, sensitization).
• Electrical Performance: Measurements confirming adherence to ANSI/AAMI EC 12:2000 standard.
• Shelf-Life: Real-time aging test results validating electrical performance against the standard over time.
• Clinical Performance (Wear Tests): Physician review of clinical performance and skin condition, along with observation of electrical signal integrity, gel integrity, and adhesion.
• Clinical Performance (Trace Comparison): Comparison of ECG traces between the new and predicate devices. The implicit ground truth here is the established performance of the predicate device.

8. Sample Size for the Training Set

This question is not applicable. The device is an ECG electrode, not an AI/ML model that requires a training set.

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

This question is not applicable, as there is no training set for this device.

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

Skintact ECG electrodes are self-adhesive, non-sterile, single use disposable ECG electrodes. All include a silver/silver chloride sensing element, a stainless steel stud and a conductive gel. These conductive elements are held in place on the patient's skin by a carrier tape coated with a pressure sensitive medical qrade adhesive.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Skintact ECG Electrodes:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective or prospective) for the electrical performance, biocompatibility, or shelf-life studies. It only mentions that the studies were performed and that the device met the requirements.

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

This information is not provided in the document. The studies referenced are technical performance tests against a voluntary standard, not studies requiring expert interpretation of diagnostic output to establish ground truth in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of performance testing against a voluntary standard for electrical characteristics and biocompatibility, an adjudication method in the context of expert consensus on ground truth is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ECG electrode, a consumable medical device, not an AI-powered diagnostic tool that would typically involve human readers interpreting output with and without AI assistance.

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

This question is not applicable to the Skintact ECG Electrodes. This is a hardware medical device (an electrode), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established by voluntary standards (ANSI/AAMI EC12/1991 for electrical performance, labeling, shelf life, packaging, and safety) and international standards (ISO 10993-1 for biocompatibility). For shelf life, it was based on real-time shelf-life studies. In essence, the ground truth was defined by the specified technical and biological requirements of these standards.

8. Sample Size for the Training Set

This information is not applicable. The Skintact ECG Electrodes are a hardware device, not a machine learning model, and therefore do not have a "training set."

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

This information is not applicable for the same reason as point 8.

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