(89 days)
10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
The 10THERMA is comprised of a main body with a touch LCD monitor, a handpiece, nonsterile mono-polar electrodes (handpiece tips), return pad connector, coupling fluid, cooling gas (cryogen), a power cable, and a foot switch. Among the consisting items, the mono-polar electrodes, return pads, and coupling fluid are single-use and disposable.
The provided text describes a 510(k) premarket notification for the 10THERMA device, which is an Electrosurgical Cutting And Coagulation Device And Accessories.
However, the document states:
"No clinical studies were considered necessary and performed."
Therefore, I cannot provide information on acceptance criteria based on clinical performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sample sizes and ground truth establishment, as these types of studies were explicitly stated as not being performed or necessary for this submission.
The document primarily focuses on non-clinical test summaries to demonstrate substantial equivalence to a predicate device, as detailed below.
1. A table of acceptance criteria and the reported device performance:
Since no clinical studies were performed, there are no reported clinical performance metrics directly tied to specific acceptance criteria for device efficacy in human subjects. The acceptance criteria described are primarily against recognized electrical safety, software validation, biocompatibility, and risk management standards.
| Acceptance Criteria Category | Standard(s) Met / Compliance |
|---|---|
| Electrical Safety | IEC 60601-1 |
| IEC 60601-1-2 | |
| IEC 60601-1-6 | |
| IEC 60601-2-2 | |
| IEC 62366-1 | |
| Software Validation | IEC 62304 |
| Biocompatibility | ISO 10993-1 |
| ISO 10993-5 | |
| ISO 10993-10 | |
| ISO 10993-23 | |
| Risk Analysis | ISO 14971 |
The document states, "The safety and performance of the product were performed. Thus, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices." This implies that the device successfully met the requirements of the listed standards, thereby demonstrating its safety and performance equivalently to the predicate.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies were performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies were performed.
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, as this device is an electrosurgical unit and not an AI-assisted diagnostic tool. No clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is an electrosurgical unit and does not involve an algorithm for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies were performed. The "ground truth" for the device's functional integrity was established through compliance with recognized performance and safety standards.
8. The sample size for the training set: Not applicable, as no clinical studies or machine learning components were described.
9. How the ground truth for the training set was established: Not applicable, as no clinical studies or machine learning components were described.
§ 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.