(47 days)
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. Non-invasive treatment of periorbital wrinkles and rhytids.
The Thermage ThermaCool System consists of the following components: - ThermaCool System . - Handpiece Assembly (consisting of Handpiece and Treatment Tip) . - Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper - Accessory cables and tubing . - Optional footswitch component ●
The provided text is a 510(k) summary for the Thermage ThermaCool System. It explicitly states that the device is substantially equivalent to predicate devices based on design, principle of operation, materials, and intended use. However, it does not contain specific information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the available information, noting where details are missing:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Thermage ThermaCool System (K033942) does not include a table of acceptance criteria or a study demonstrating the device's performance against such criteria. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than reporting on specific performance outcomes from a dedicated study.
Missing Information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Explanation of document content:
The 510(k) summary (K033942) for the Thermage ThermaCool System asserts its substantial equivalence to previously cleared Thermage ThermaCool systems (e.g., K021402, K013639, K013034, K003183, K000944) and the ThermaCool Coupling Fluid TF-2 (K030142).
The key statement regarding its compliance is:
"By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently cleared for marketing in the United States."
This indicates that the device's technological characteristics, indications for use (Dermatologic and General Surgical procedures for electrocoagulation and hemostasis, and non-invasive treatment of periorbital wrinkles and rhytids), and safety profile are considered comparable to those of already approved devices, rather than being evaluated against new, specific performance acceptance criteria in a dedicated study documented here.
§ 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.