(463 days)
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
| Acceptance Criteria (Set by Voluntary Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC12/1991 for Electrical Performance | Meets requirements |
| ANSI/AAMI EC12/1991 for Labeling | Meets requirements |
| ANSI/AAMI EC12/1991 for Shelf Life | Meets requirements |
| ANSI/AAMI EC12/1991 for Packaging | Meets requirements |
| ANSI/AAMI EC12/1991 for Safety | Meets requirements |
| ISO 10993-1 for Biocompatibility (material selection) | Appropriate levels of biocompatibility demonstrated |
| Shelf Life substantiation | Data obtained in real-time shelf life studies substantiate claimed shelf life |
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.
§ 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.