(23 days)
ECG Skintact 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 single use, non-sterile and disposable and are to be used on intact (uninjured) skin.
All Skintact® ECG Tab Electrodes are self-adhesive, non-sterile, single use disposable electrodes. The Skintact® ECG Tab Electrodes with KH06D Gel are composed of the same materials as the predicate devices by Leonhard Lang except the modified gel.
Here's an analysis of the provided 510(k) summary regarding the Skintact® ECG Tab Electrodes with KH06D Gel, focusing on acceptance criteria and the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993 for intact skin | Cleared and passed ISO 10993; materials confirmed biocompatible; change does not introduce new risks. |
| Electrical Performance: ANSI/AAMI EC12:2000/(R)2005 | Met specifications as established in the standard. Additionally, the predicate device (K030509) also met this standard. |
| Shelf Life: Tested in accelerated aging | Tested in the same manner as the predicate device (K030509). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for the test set.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance testing against established standards (biocompatibility, electrical performance, shelf life), it's highly likely this was prospective testing conducted by the manufacturer to verify compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For this specific device (ECG electrodes), the "ground truth" is typically established by objective measurements and standardized tests rather than expert interpretation of images or patient data. The provided documentation does not mention using experts to establish ground truth for the performance testing. Instead, the ground truth is defined by the requirements of the standards (ISO 10993, ANSI/AAMI EC12).
4. Adjudication Method for the Test Set
As the "ground truth" is based on objective measurements against industry standards, an adjudication method like "2+1" or "3+1" (which typically applies to human interpretation tasks) is not applicable here and is not mentioned in the document.
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 type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical accessory (ECG electrode), and its performance is evaluated through technical standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance assessments of the device itself (the ECG electrode). The biocompatibility, electrical performance, and shelf-life tests involve the device operating on its own or in a controlled environment, without a human-in-the-loop for its basic function.
7. The Type of Ground Truth Used
The ground truth used for the performance testing is based on objective technical standards and material properties:
- Biocompatibility: Conformance to ISO 10993 standards.
- Electrical Performance: Conformance to ANSI/AAMI EC12:2000/(R)2005 specifications.
- Shelf Life: Results of accelerated aging tests, compared to the predicate device's established shelf life.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning or AI algorithms. As this device is an ECG electrode and not an AI/ML diagnostic tool, there is no training set in the conventional sense mentioned or implied for its development or testing.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, the question of how its ground truth was established is not applicable.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.