(57 days)
The Thermi RF accessories used with the Thermi RF Generator System are indicated:
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- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
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- to create lesions in nervous tissue when used in combination with Thermi RF Generator.
The Thermi RF Accessories (electrodes, cannula, adapter cable) are designed to provide finely-controlled radiofrequency (RF) energy in combination with the predicate device Thermi RF Generator (K130689).
This document is a 510(k) premarket notification for Thermi RF Accessories (electrosurgical cutting and coagulation devices and accessories). It states that the accessories are substantially equivalent to previously cleared devices. It describes performance data related to electrical safety and bench testing, but these are general engineering qualifications for device function, not specific clinical performance metrics related to diagnostic accuracy or AI performance.
Therefore, the requested information specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device cannot be fully extracted as this is not an AI/ML device. The document does not describe studies with test sets, ground truth, expert consensus, or MRMC studies.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from this document) | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | |
| IEC 60601-1: 2006 | Compliance shown |
| IEC 60601-1-2: 2001 | Compliance shown |
| IEC 60601-1-4: 1996 | Compliance shown |
| IEC 60601-1-6: 2006 | Compliance shown |
| IEC 60601-2-2: 2009 | Compliance shown |
| Bench Testing (Design Specifications): | |
| Temperature measurement | Met all performance |
| Tensile strength | Met all performance |
| Functional testing | Met all performance |
| Design features | Met all performance |
| Heat shrink | Met all performance |
| Active tip length | Met all performance |
| Packaging | Met all performance |
| Shelf-life | Met all performance |
| Functional and Simulated Use Verification: | |
| Function as intended with Thermi RF Generator | Functioned as intended |
2. Sample sized used for the test set and the data provenance: Not applicable. The document describes engineering and bench testing, not clinical studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not mentioned as this is not an AI/ML device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set involving human interpretation/adjudication is described.
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 is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical electrosurgical accessory, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be engineering specifications and standards, not clinical ground truth.
8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set or its ground truth.
§ 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.