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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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