(26 days)
The Thermi Reusable Non-Invasive RF Electrodes used with the Thermi RF Generator System are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
The Thermi Reusable Non-Invasive RF Electrode is a transcutaneous thermal/coagulation electrode designed to provide finely-controlled radiofrequency (RF) energy in combination with Thermi RF Generator. They are not intended to function with non-Thermi branded products.
The electrode connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit. The Electrode delivers the RF signal from the generator to the electrode active tip. From the active tip, the RF signal triggers the tissue molecules to vibrate resulting in the formation of heat.
The provided text describes a 510(k) summary for the Thermi Reusable Non-Invasive RF Electrode. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria in the context of diagnostic performance (like sensitivity/specificity) for an AI/CAD device.
Based on the information provided, it's not possible to extract the acceptance criteria and study details as typically defined for AI/CAD devices. The document outlines bench testing to verify design specifications and ensure the modified device (an electrode for an electrosurgical system) performs as intended and is as safe and effective as the predicate device.
Here's an attempt to answer your questions based on the available information, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria (e.g., minimum accuracy, sensitivity) and device performance statistics as would be expected for an AI/CAD system. Instead, it refers to general compliance with standards and successful completion of bench tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Specifications | Met all design specifications |
| Functional Testing | Functioned as intended |
| Dimensional Testing | Successful |
| Tensile Strength | Successful |
| Electromagnetic Compatibility (EMC) | Demonstrated compliance to IEC 60601-1-2 |
| Electrical Safety | Demonstrated compliance to IEC 60601-1, IEC 60601-1-4, IEC 60601-1-6, and IEC 60601-2-2 |
| Safety and Efficacy (Overall) | As safe and effective as the legally marketed predicate device; no new safety or performance questions raised. |
2. Sample size used for the test set and the data provenance
The document refers to "a series of bench testing" performed on modified electrodes. It does not specify a "test set" in the context of patient data or clinical images, nor does it mention a specific sample size of electrodes tested. No provenance information (country of origin, retrospective/prospective) is applicable as it's bench testing, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device and testing. The "ground truth" here would be the engineering specifications and performance standards established by Thermi and relevant regulatory bodies.
4. Adjudication method for the test set
Not applicable, as there is no diagnostic test set or expert review process 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 device is an electrosurgical electrode, not an AI/CAD system for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The device, an RF electrode, functions as a tool for a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device (an RF electrode), the "ground truth" for the bench testing would be:
- Engineering Specifications: Adherence to design parameters (dimensions, materials).
- Performance Standards: Meeting predefined functional outputs (e.g., specific RF energy delivery, temperature profiles, tensile strength).
- Compliance with International Standards: Adherence to standards like IEC 60601 series for electrical safety and electromagnetic compatibility.
There is no mention of expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.