(145 days)
The Tender-Trode® Prewired electrode is a disposable, noninvasive electrode that is intended to be used for resting ECG monitoring on neonatal and pediatric patients in a hospital setting. These electrodes can be used for short-term or long-term applications, up to 24 hours. The Tender-Trode of prewired electrodes are single-use, non-sterile, disposable and are to be used on intact (uninjured) skin.
A conductive solid gel electrode consisting of a conductive adhesive gel, a silver/silver chloride plated ABS eyelet, an adhesive cloth substrate, vinyl label, 24" wire w/.060 dia. female socket and polystyrene release liner.
Here's an analysis of the provided text regarding the Tender-Trode® Prewired ECG Electrodes, addressing your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Performance | EC12:2000 for Disposable ECG Electrodes | Meets or exceeds the performance specifications established in EC12:2000. Test results indicate conformance. |
| Labeling | EC12:2000 AAMI standard for labeling | Meets EC12:2000 AAMI standard for labeling. |
| Shelf Life | EC12:2000 AAMI standard for shelf life | Data obtained in accelerated shelf life studies substantiates claimed shelf life. |
| Packaging | EC12:2000 AAMI standard for packaging | Meets EC12:2000 AAMI standard for packaging. |
| Safety | EC12:2000 AAMI standard for safety | Meets EC12:2000 AAMI standard for safety. |
| Biocompatibility | Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact (Cytotoxicity, Sensitization, Primary Skin Irritation) | Materials were found to be non-irritating, non-cytotoxic, and non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size used for the test set (i.e., the number of electrodes tested for performance, shelf life, or biocompatibility). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests, beyond indicating that accelerated shelf life studies were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" concept, especially involving expert consensus, is typically relevant for interpretative devices like those using AI in medical imaging. For a physical device like an ECG electrode, ground truth is established through adherence to engineering standards and validated laboratory testing, not expert interpretation of results.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple human readers or algorithms interpret data to reach a consensus, often in diagnostic imaging. For a physical device demonstrating adherence to standards, the "adjudication" is inherent in the standardized testing methodologies themselves and the objective measurements obtained.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not described in this document. This type of study is specifically designed to compare the diagnostic performance of human readers, often with and without AI assistance, across multiple cases. The Tender-Trode® is a physical medical device (an ECG electrode), not a diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms. The device being reviewed is a physical electrode. Its performance is assessed through its physical and electrical characteristics as determined by standardized tests, not by an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Tender-Trode® Prewired ECG Electrodes is established by adherence to internationally recognized consensus standards, specifically EC12:2000 for Disposable ECG Electrodes and ISO 10993-1 for Biocompatibility. For biocompatibility, this ground truth is further supported by specific biological tests (Cytotoxicity, Sensitization, and Primary Skin Irritation) with objective endpoints.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The concept of a "training set" refers to data used to train machine learning models. The Tender-Trode® is a physical medical device, not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As stated above, there is no training set for this device.
§ 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.