(151 days)
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids
- Non-invasive treatment of facial wrinkles and rhytids
The Thermage ThermaCool System consists of the following components:
- RF Generator .
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing .
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Cooling Module connect to the RF Generator.
This document is a 510(k) premarket notification for the Thermage ThermaCool System. It focuses on demonstrating substantial equivalence to a predicate device and safety aspects like sterilization and biocompatibility rather than demonstrating the performance of an AI/ML device against specific clinical acceptance criteria through a study.
Therefore, many of the requested sections about AI/ML device performance studies, such as sample sizes for test and training sets, ground truth establishment, MRMC studies, and stand-alone performance, are not applicable to the information provided.
However, I can extract information related to quality control and safety acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Compliance |
|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ SAL verified in accordance with EN 550, utilizing the half-cycle method of sterilization validation for the Thermage Treatment Tip. |
| Ethylene Oxide (EO) Residuals (Treatment Tip) | Acceptable EO residual levels in conformance with ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. Allowable limits for "limited exposure" devices (up to 24 hours): 20 mg EO and 12 mg ECH (average daily dose). Verification of being below allowable limits confirmed as part of EO cycle and product aeration validation. Manufactured product routinely monitored (minimum quarterly). |
| Ethylene Oxide (EO) Residuals (Skin Marking Paper) | Acceptable EO residual levels in conformance with ISO 10993-7. Allowable limits for "limited exposure" devices (up to 24 hours): 20 mg EO and 12 mg ECH (average daily dose). Verification of being below allowable limits confirmed as part of EO cycle and product aeration validation. Manufactured product routinely monitored (minimum quarterly). |
| Sterilization Contract | Sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. |
| Substantial Equivalence to Predicate Device | The technological characteristics and clinical use data of the ThermaCool System for the expanded indication are substantially equivalent to the previously cleared ThermaCool TC System (K021402). The device, by virtue of design, principle of operation, materials, and intended use, is substantially equivalent to devices currently cleared for marketing in the United States. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes compliance with sterilization and biocompatibility standards, and substantial equivalence, not a clinical efficacy or performance study with a test set of data in the context of AI/ML.
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)
Not applicable. Ground truth for clinical performance for an AI/ML device is not mentioned as this is a 510(k) for an electrosurgical unit.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of a test set.
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 not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an electrosurgical unit, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the compliance aspects (sterilization, residuals), the "ground truth" is defined by adherence to established international standards (EN 550, ISO 10993-7) and regulatory requirements (21 CFR 801.150). For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device (ThermaCool TC, K021402).
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.