(70 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 (and as also to be offered for sale under various private label tradenames) are self-adhesive, non-sterile, 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 describes the 510(k) premarket notification for the Skintact® Cool Contact Electrosurgical Grounding Plates. This documentation primarily focuses on establishing substantial equivalence to existing predicate devices and demonstrating compliance with safety and performance standards for electrosurgical grounding plates. It does not describe a device that uses AI, nor does it involve a test set with expert adjudication for AI performance evaluation. Therefore, many of the requested fields are not applicable to the information contained within this document.
Here's an analysis based on the provided text, addressing the applicable criteria for this type of medical device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by ANSI/AAMI HF 18:2001) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | No adverse results reported |
| Skin Irritation | No adverse results reported |
| Sensitization | No adverse results reported |
| Performance & Safety (according to ANSI/AAMI HF 18:2001): | |
| Maximum safe temperature rise | Conforms to standard |
| Electrode contact impedance | Conforms to standard |
| Electrode adherence (Pull test) | Conforms to standard |
| Conformability test | Conforms to standard |
| Fluid tolerance test | Conforms to standard |
| Shelf-life: | |
| 24 months | Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state specific sample sizes for the individual tests (biocompatibility, temperature rise, impedance, etc.). It generally refers to "the following testing." The testing was conducted by TÜV Product Service GmbH in Munich, Germany, indicating the country of origin for the data is Germany. The nature of these engineering and materials tests (e.g., maximum safe temperature rise, pull test) is typically prospective as they are performed in a controlled laboratory setting to evaluate the device's characteristics against predefined standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. This is a submission for an electrosurgical grounding plate, not an AI-powered device that requires expert-established ground truth for a test set. The "ground truth" here is defined by established engineering standards and validated laboratory test methodologies referenced in ANSI/AAMI HF 18:2001.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. This type of device does not involve human adjudication of a test set in the way AI performance is evaluated. Compliance is determined by objective measurements against a standard.
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
This is not applicable. This device is an electrosurgical grounding plate, not an AI diagnostic or assistive tool. No human readers or AI assistance are involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcome data, etc.)
The "ground truth" for the performance and safety tests is defined by recognized international standards and validated test methodologies, specifically ANSI/AAMI HF 18:2001 "Electrosurgical devices." For biocompatibility, it's based on established biological evaluation standards.
8. The sample size for the training set
This is not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established
This is not applicable. This device does not use machine learning or require a training set.
§ 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.