(35 days)
Skintact® Cool Contact Electrosurgical Grounding Plates are designed for use with electrosurgical generators for cutting and coagulation of human tissue.
Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel (and as also to be offered for sale under various private label tradenames) are self-adhesive, nonsterile, single use disposable electrodes, available in a comprehensive range of shapes and sizes (adult and pediatric), standard and split, with or without lead wires.
The provided text is a 510(k) summary for a medical device. It describes the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical or diagnostic AI study would.
Instead, the "study" referred to here is a series of engineering and biocompatibility tests conducted to demonstrate that the device, which is an electrosurgical grounding plate with a new gel formulation, meets the safety and performance requirements of a recognized standard (ANSI/AAMI HF 18:2001) and is substantially equivalent to a previously cleared predicate device.
Therefore, I will extract information based on this context.
Here's an interpretation based on the provided text, recognizing its nature as a 510(k) summary rather than a standalone AI or clinical study:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter / Acceptance Criteria (from ANSI/AAMI HF 18:2001) | Reported Device Performance |
|---|---|
| Cytotoxicity (Biocompatibility) | No adverse results |
| Skin Irritation (Biocompatibility) | No adverse results |
| Sensitization (Biocompatibility) | No adverse results |
| Maximum safe temperature rise | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode contact impedance | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode adherence: Pull test | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode adherence: Conformability test | According to ANSI/AAMI HF 18:2001 (implied met) |
| Electrode adherence: Fluid tolerance test | According to ANSI/AAMI HF 18:2001 (implied met) |
Notes on Acceptance Criteria: The document states that "All performance and safety tests are according to ANSI/AAMI HF 18:2001." This implies that the acceptance criteria for each test are those set forth in that recognized standard. The summary does not provide specific numerical thresholds from the standard, but affirms that the device met them.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The testing involved "Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel" across a "range of electrodes with different geometry and area." The specific number of units tested per parameter is not provided.
- Data Provenance: The tests were conducted by Leonhard Lang GmbH, Austria, and Univ. Klinik für Radiodiagnostik, Innsbruck, Austria. This indicates the data is prospective, generated specifically for this submission. The country of origin is Austria.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Two experts are mentioned: Dr. Michael Verius and Dr. Ralf Huttary.
- Qualifications: Both are from the Univ. Klinik für Radiodiagnostik, Anichstraße 35, 6020 Innsbruck, Austria. Their specific specialties or years of experience are not listed, but their affiliation with a university radiology clinic suggests medical and perhaps technical expertise relevant to device performance evaluation. They acted as a testing facility rather than establishing a ground truth in a diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. This was not a study involving human interpretation of diagnostic data requiring adjudication of ground truth. The "adjudication" was effectively the testing against a standard and the determination of "no adverse results" or "according to standard."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not an MRMC study. It was a technical performance and biocompatibility study comparing the new device characteristics to those required by a recognized standard and demonstrating equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the performance tests outlined (Maximum safe temperature rise, Electrode contact impedance, etc.) represent a "standalone" evaluation of the device's physical and electrical properties without human intervention during the measurement process. However, this is not an "algorithm-only" performance in the context of AI.
7. Type of Ground Truth Used
The ground truth was based on:
- Recognized Standard: ANSI/AAMI HF 18:2001, which defines the safety and performance requirements for electrosurgical devices.
- Biocompatibility Standards: Implicitly, the biocompatibility tests (Cytotoxicity, Skin Irritation, Sensitization) follow established standards for evaluating material safety for medical devices.
- Predicate Device: The performance and materials were assessed for equivalence to the predicate device (K030362).
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning study.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set mentioned.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.