(30 days)
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation.
Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated for temporary reduction in circumference of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
The modified truSculpt RF device consists of a console; one 16 cm² RF handpiece; up to six 40 cm² puck-style RF handpieces that can attach to belts configured for hands-free abdominal and flank treatments for circumferential reduction; adjustable patient belts; a patient comfort switch; and a truGlide massage roller. All system functions are controlled through the console. The handpieces deliver RF energy to generate a heating profile that produces a moderate temperature rise in the subcutaneous tissue, while monitoring epidermal temperature. In addition, there is a separate mechanical roller that can be used as a massager.
The provided document K172004 is a 510(k) premarket notification for a medical device called "truSculpt". It primarily focuses on demonstrating substantial equivalence to predicate devices and describes modifications to the existing truSculpt RF device. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered diagnostic device, which is what the prompt is implicitly asking for (e.g., using terms like "human readers improve with AI vs without AI assistance", "standalone (i.e. algorithm only without human-in-the-loop performance)", "ground truth").
The truSculpt device is an electrosurgical cutting and coagulation device, specifically an RF energy device for topical heating, temporary reduction in circumference of the abdomen, and temporary reduction in the appearance of cellulite, and a massage device. This is a physical device used for treatment, not an AI-powered diagnostic tool.
Therefore, I cannot provide the requested information from this document. The document describes:
- Device: truSculpt (RF energy device and massage device).
- Modifications: Addition of a multiplexor board to power up to six treatment handpieces sequentially, a patient-activated treatment termination switch, and belts for hands-free operation of 40 cm² handpieces for circumferential reduction.
- Safety and Performance Data: Reference to compliance with IEC 60601-1 standards (general safety, usability, electromagnetic disturbances, high-frequency surgical equipment) and AAMI/ANSI ES60601-1. It also mentions software verification and validation (V&V) for the patient comfort switch and multiplexor board.
- Clinical Trial Mention: States that "the identical treatment parameters are available for selection as used in the clinical trial to gain this indication for use, including area treated and RF dose (time and temperature)" for abdominal circumferential reduction treatments. However, it does not provide details of this clinical trial or specific performance metrics from it in a way that relates to the prompt's request for AI acceptance criteria.
Based on the provided document, I cannot fill out the requested table or answer the specific questions related to AI device performance and ground truth establishment. The document is about a physical device's electrical safety and functional equivalence, not an AI model's diagnostic performance.
§ 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.