(239 days)
The Gladiator system contains three handpieces, each of which has its own indications for use.
The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:
- PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
- . BodySculp - a low level laser
- . BodyTone (previously called Futura Pro) – an electronic muscle stimulator
The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.
The provided text is a 510(k) premarket notification FDA review letter for the "Gladiator" device. It outlines the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not contain the kind of detailed information about acceptance criteria for an AI/ML diagnostic device, nor does it describe a study specifically proving that the device meets such criteria in terms of algorithm performance against a ground truth.
Specifically:
- There's no mention of an AI/ML component in the Gladiator device. The device is described as a multi-function system combining RF Microneedling, Low Level Laser, and Electronic Muscle Stimulation (EMS) technologies.
- The "Performance Testing" section focuses on electrical safety, EMC, software lifecycle processes, risk management, and thermal testing, which are standard for electrosurgical and laser devices. This is not performance testing for an AI algorithm's diagnostic accuracy.
- There is no ground truth establishment, multi-reader multi-case studies, or standalone algorithm performance data discussed.
- The testing described is primarily engineering and safety-related (e.g., thermal damage profiles in ex vivo tissues), not clinical diagnostic accuracy.
Therefore, I cannot provide the requested information as the input document does not describe a study involving performance assessment of an AI/ML algorithm against acceptance criteria for diagnostic accuracy. The document is for a physical medical device (Gladiator) that does not appear to have an AI/ML component requiring the type of performance evaluation outlined in your request.
§ 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.