(83 days)
The Coated Electrosurgical Electrodes are intended for the following indications: Cutting of Soft Tissue, Coagulation of Soft Tissue.
Not Found
The provided 510(k) summary for K132224 describes the Unimed Surgical Coated Electrosurgical Electrodes. This document does not detail a study involving AI performance, human readers, or image analysis, as it pertains to a physical medical device (electrosurgical electrodes) rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance, expert adjudication, MRMC studies, and ground truth for AI models are not applicable.
Here's an analysis of the provided information based on the sections that are relevant to the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum Coating Adhesion ≥ 3.5 lbs. | Compliant (Implied by statement "Verification testing of the electrodes was performed sufficient to confirm that the products meet their specifications.") |
| Minimum 10-lbs Pull Force (Attachment to Pencil compliant with IEC 60601-2-2) | Compliant (Implied by statement "Verification testing of the electrodes was performed sufficient to confirm that the products meet their specifications.") |
| Coating Performance and integrity for aged devices at Normal and Extreme use conditions | Confirmed (Implied by statement "Performance and integrity of the coatings of aged devices were confirmed at Normal and Extreme use conditions.") |
| Dielectric Strength (per IEC 60601-2-2) | Compliant (Implied by statement "Verification testing of the electrodes was performed sufficient to confirm that the products meet their specifications.") |
| Hipot Testing (per IEC 60601-2-2) | Compliant (Implied by statement "Verification testing of the electrodes was performed sufficient to confirm that the products meet their specifications.") |
| Biocompatibility meets requirements of ISO 10993-1 | Meets requirements of ISO 10993-1 |
| Color Additives are GRAS and non-toxic (per Code of Federal Regulations) | Listed as GRAS and are non-toxic in the Code of Federal Regulations |
| Shelf Life established using Arrhenius Model | Established (Implied by statement "Shell Life date using the Arrhenius Model.") |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size in the way it might for an AI model. For physical testing of the electrodes, the sample sizes for each specific test (e.g., coating adhesion, pull force, electrical testing) are not provided in this summary. The data provenance is internal to Unimed Surgical Products, Inc. for the verification testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device, and the ground truth for its performance is established through engineering and biological testing against predefined specifications and standards (e.g., IEC 60601-2-2, ISO 10993-1). No human experts are described as "establishing ground truth" in the context of diagnostic performance for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this relates to human expert review for establishing ground truth in diagnostic studies, which is not relevant here.
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 electrosurgical electrode and does not involve AI assistance for human readers or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical electrode and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on established engineering specifications, international standards (e.g., IEC 60601-2-2 for electrical safety, ISO 10993-1 for biocompatibility), and regulatory requirements. For example:
- Physical Testing: Measured values (e.g., pull force, adhesion strength) compared against predefined minimums.
- Electrical Testing: Compliance with specified electrical characteristics according to industry standards.
- Biocompatibility: Adherence to the requirements of ISO 10993-1 for biological safety.
8. The sample size for the training set
Not applicable. This is a physical device, and the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this physical device.
§ 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.