(9 days)
PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician.
Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are non-sterile and are to be used on intact (uninjured) skin.
ECG Tab electrodes are composed of a PET tape, Ag/AgCl ink and a conductive gel. These are configured as 10 (ten) electrodes applied to a siliconized transparent PET card, ten cards per pouch.
The provided document describes the 510(k) summary for the PROTAB ECG TAB ELECTRODE. Here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Performance | Conforms to ANSI/AAMI EC12:2000 (ECG Electrodes) | "PROTAB ECG Tab Electrodes have been tested and conforms to ANSI/AAMI EC12:2000" |
| Biocompatibility | Selection of materials demonstrating appropriate levels of biocompatibility based on ISO 10993-1 | "assured through the selection of materials which demonstrate appropriate levels of biocompatibility" |
| Shelf Life | Substantiated for an expiration of 24 months | "Accelerated aging testing was performed to substantiate an expiration of 24 months." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance or shelf-life testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the document. The device is an ECG electrode, and grounding truth in this context would refer to the performance standards it meets, not clinical interpretations by experts. The relevant "ground truth" is the ANSI/AAMI EC12:2000 standard itself.
4. Adjudication Method for the Test Set
This is not applicable and not provided. Performance testing against standards like ANSI/AAMI EC12:2000 typically involves objective measurements and comparisons, not expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done, as it is not relevant for an ECG electrode. This type of study investigates how human readers (e.g., radiologists) perform with and without AI assistance in diagnostic tasks. The PROTAB ECG TAB ELECTRODE is a physical medical device, not an AI-based diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done as the device is not an algorithm.
7. Type of Ground Truth Used
The primary "ground truth" used for demonstrating performance is adherence to the ANSI/AAMI EC12:2000 standard for ECG Electrodes. This standard defines the requirements for performance, safety, and labeling of disposable electrodes for electrocardiography. For biocompatibility, the ground truth is adherence to ISO 10993-1.
8. Sample Size for the Training Set
This product is an ECG electrode, not a machine learning model, so there is no training set and therefore no specified sample size for it.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question 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.