(27 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 Electrodes (and as also to be offered for sale under various private label tradenames) will now also be offered with solid adhesive gel. Just like the liquid gel electrodes, solid adhesive gel electrodes are self-adhesive, non-sterile, single use disposable snap electrodes. The solid adhesive electrodes are identical in size, shape and configuration to the liquid gel Skintact ECG electrodes currently marketed by Leonhard Lang, GmbH. All electrode configurations include a stainless steel stud to guarantee an unimpaired performance during the shelf-life of the product. All electrodes include an ABS sensor element coated with silver. The silver layer is either completely or partially (in the areas in contact with the conductive gel) covered with a silver chloride layer. This is the same construction as the current Skintact® ECG electrode using liguid gel conducting media.
Here's a breakdown of the acceptance criteria and study information for the Skintact® ECG Electrode, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Materials are biocompatible. Testing showed no adverse results for Cytotoxicity, Skin Irritation, and Sensitization. |
| Electrical Performance (ANSI/AAMI EC 12:2000) | - AC Impedance: Met requirements of ANSI/AAMI EC 12:2000. |
- DC Offset Voltage: Met requirements of ANSI/AAMI EC 12:2000.
- Defibrillation Overload Recovery: Met requirements of ANSI/AAMI EC 12:2000.
- Combined Offset Instability and Internal Noise: Met requirements of ANSI/AAMI EC 12:2000.
- Bias Current Tolerance: Met requirements of ANSI/AAMI EC 12:2000. |
| Shelf Life (24 months) | The electrical performance of electrodes with solid adhesive gel stays within ANSI/AAMI EC12-2000 limits for 24 months, as confirmed by real-time and accelerated aging (3 months at 40°C). |
| Equivalence to Liquid Gel Electrodes (Electrical) | Electrical performance of solid adhesive gel electrodes is equivalent to liquid gel electrodes, with negligible differences compared to ANSI/AAMI EC12-2000 limits. |
| Clinical Performance (Signal Quality) | Clinical trace testing confirmed that the solid adhesive gel performs the same as liquid gel, demonstrating equivalence in ECG traces. |
| Clinical Performance (Wear Test - 48 hours) | - No deterioration of electrical performance. - Gel did not dry out.
- Electrodes were not replaced and showed no displacement, even with normal activities and sports.
- No skin problems/irritation for volunteers. |
Study Information
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size:
- For biocompatibility: Not specified in detail, but implied to be sufficient for cytotoxicity, skin irritation, and sensitization tests.
- For electrical testing: Not specified, but a "certification to conformance EC12:2000 with this standard has been provided." This implies sufficient devices were tested to meet the standard.
- For shelf-life: Electrodes were used for real-time and accelerated aging, but the specific number is not provided.
- For clinical trace testing: Not specified, but implied to be sufficient to evaluate the potential effect of material change.
- For wear tests: "Three wear test reports" were provided. The number of volunteers per report is not explicitly stated.
- Data Provenance: The document implies the testing was conducted by Leonhard Lang GmbH (based in Austria). The data is retrospective in the sense that it's reported after the testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
- Wear Tests: "A physician reviewed the performance of the wear tests and examined for skin irritation." The number of physicians is not specified (it states "a physician," implying one, but doesn't explicitly rule out more if separate reports were reviewed). Qualifications are stated as "physician."
4. Adjudication Method for the Test Set:
- Not applicable/Not specified as human "reader" adjudication in the typical sense for image-based diagnostics. The assessments were based on meeting objective electrical standards and physician review for wear tests.
5. 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:
- Not applicable. This device is an ECG electrode, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an ECG electrode; its performance is standalone in the sense that it collects the ECG signal itself, without an AI algorithm.
7. The Type of Ground Truth Used:
- Electrical Performance: Ground truth was defined by the requirements of the ANSI/AAMI EC 12:2000 "Disposable ECG electrodes" standard.
- Biocompatibility: Ground truth was based on established biocompatibility testing standards (cytotoxicity, skin irritation, sensitization).
- Clinical Performance (Wear Test): Ground truth was based on direct observation and clinical assessment by a physician regarding electrode performance (electrical stability, gel integrity, adhesion) and patient outcomes (skin irritation).
- Equivalence: Comparisons were made against performance data from the predicate liquid gel electrodes and against the ANSI/AAMI EC 12:2000 limits.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical device (electrode), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was established:
- Not applicable (as above).
§ 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.