(193 days)
The radiofrequency-energy only delivery components of the Thermage FLX System are indicated for use in:
· Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
· Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
· Non-invasive treatment of wrinkles and rhytids.
The simultaneous application of radio frequency energy and skin vibration by the Thermage FLX System is indicated for use in:
· Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
· Non-invasive treatment of periorbital wrinkles and rhytids;
· Non-invasive treatment of wrinkles and rhytids;
· Temporary improvement in the appearance of cellulite;
· Relief of minor muscle aches and pains;
· Relief of muscle spasms;
· Temporary improvement of local circulation (i.e., blood circulation).
The Thermage FLX System is based on the technology and the performance of the existing Thermage CPT System and includes a similar RF (RF) Generator and Accessories.
The Thermage FLX System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage FLX System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.
The Thermage FLX System is comprised of three sub-systems: (1) the Console, (2) Handpiece and (3) Treatment Tip. Accessories used during each individual treatment included the Return Pad, Skin Marking Grid Paper, Coupling Media, Cryogen and an optional Footswitch.
The provided document, a 510(k) summary for the Thermage FLX System, describes the device, its intended use, and a comparison to predicate devices, but does not contain information about specific acceptance criteria, a clinical study proving the device meets those criteria, or the details typically associated with clinical trial reporting (sample size, data provenance, expert adjudication, MRMC studies, ground truth establishment, or training set details).
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with electrical and safety standards.
Therefore, the requested information based solely on the provided text is largely unavailable.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that the device passes various electrical and safety standards, but it doesn't present specific performance metrics or acceptance criteria for clinical effectiveness (e.g., wrinkle reduction percentage, cellulite improvement rate, etc.) that would typically be associated with an "acceptance criteria" table for device performance.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document details non-clinical tests (electrical safety, EMC, software, biocompatibility) but does not mention any clinical test set, subjects, or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. As no clinical test set is described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This information is not provided. The document does not mention any MRMC studies or human reader improvement with or without AI assistance, as the device itself is not described as an AI or diagnostic tool requiring such studies. It's an energy-based therapeutic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided. This question is not applicable as the device is not an algorithm acting in a standalone capacity; it's a physical medical device.
7. The Type of Ground Truth Used
This information is not provided as no clinical study or test set requiring ground truth is described. For the non-clinical tests, compliance with specified standards (e.g., IEC 60601-1) serves as the "ground truth" for safety and electrical performance.
8. The Sample Size for the Training Set
This information is not provided. The device is an energy-based system, not an AI or machine learning algorithm, so the concept of a "training set" in this context is not applicable.
9. How the Ground Truth for the Training Set was Established
This information is not provided, as there is no training set mentioned.
Summary based on the document:
The Thermage FLX System's "study" in this 510(k) context primarily refers to non-clinical testing to demonstrate compliance with relevant electrical, safety, and software standards, as well as functional, simulated use, environmental, and transport testing. The acceptance criteria for these tests are typically defined by the requirements of the standards themselves (e.g., passing specific electrical safety limits, meeting EMC requirements). The document asserts that the device passed all applicable standards testing, thereby demonstrating its safety and functional equivalence to predicate devices. It relies on a demonstration of substantial equivalence to previously cleared devices (Thermage ThermaCool CPT cleared under K090580 and K132431) rather than a de novo clinical trial with specific clinical performance acceptance criteria.
§ 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.