(13 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 recording. Skintact ECG electrodes are non-sterile and are to be used on intact (uninjured) skin.
Skintact® ECG Tab Electrodes (and also to be sold under various private label tradenames) with KH 06 gel. Skintact® ECG Tab Electrodes with KH 06 gel are self-adhesive, non-sterile, single use disposable electrodes for diagnostic resting ECG. ECG Tab electrodes are composed of a PET tape, carbon ink and 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.
Here's an analysis of the provided text regarding the Skintact® ECG Tab Electrodes, focusing on the acceptance criteria and the study proving conformance:
This document is a 510(k) premarket notification for an ECG electrode, which means it describes the device's substantial equivalence to a predicate device rather than presenting novel clinical study results for a new AI medical device. Therefore, much of the requested information regarding AI device development and testing (like MRMC studies, training set details, and highly detailed ground truth establishment) is not applicable to this submission.
However, I can extract the acceptance criteria for the performance of the ECG electrodes and the studies conducted to show they meet those criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility | Confirmed by biocompatibility testing. |
| AC Impedance | Tested in accordance with ANSI/AAMI EC 12:2000. |
| DC Offset Voltage | Tested in accordance with ANSI/AAMI EC 12:2000. |
| Defibrillation Overload Recovery | Tested in accordance with ANSI/AAMI EC 12:2000. |
| Combined Offset Instability and Internal Noise | Tested in accordance with ANSI/AAMI EC 12:2000. |
| Bias Current Tolerance | Tested in accordance with ANSI/AAMI EC 12:2000. |
| Shelf Life (24 months) | Demonstrated by real-time aging and accelerated aging (3 months at 40°C). Manufacturer has 20 years of experience with current packaging. |
| Clinical ECG Signal Quality | Provides a reliable signal tracing of consistently high quality. |
Study Details (as much as applicable to this type of device submission)
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Sample Size used for the test set and the data provenance:
- Clinical Data: Three ECG tracings were made. The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified. Each tracing contained more than 10 seconds of data.
- Performance (ANSI/AAMI EC 12:2000) & Shelf Life Testing: The sample sizes for these tests are not explicitly stated in the provided text. These would typically involve a specific number of electrodes or batches tested according to the standard's protocols. The shelf-life testing involved "electrodes" in an incubator.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of device (ECG electrode), "ground truth" isn't established by expert consensus in the typical sense of diagnostic imaging or clinical decisions.
- For the clinical data, the assessment of "reliable signal tracing of consistently high quality" would likely be a qualitative assessment by an expert familiar with ECG waveform interpretation, but the number and qualifications of such experts are not mentioned.
- For the technical performance tests (ANSI/AAMI EC 12:2000), the "ground truth" is adherence to the specified technical parameters of the standard, measured by calibrated equipment. Experts in electrophysiology or biomedical engineering would interpret these results, but they aren't establishing a diagnostic ground truth.
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Adjudication method for the test set:
- Not applicable in the typical sense for this device. The technical tests are pass/fail against a standard. The clinical tracings would have a single "assessment" outcome for signal quality.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-powered diagnostic device; it is a passive ECG electrode. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant or performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device. The device's performance is inherently "standalone" in that its electrical characteristics are measured directly.
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The type of ground truth used:
- For technical performance: Adherence to the technical specifications outlined in the ANSI/AAMI EC 12:2000 standard.
- For clinical data: Qualitative assessment of ECG signal quality.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.