(233 days)
The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.
The InMode RF System including the InMode RF Hand piece (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.
The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF Hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes.
Following are the InMode RF System specifications: RF Max Output Power: 20 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 35cm W x 46cm D x 100cm H (14.2'' W x 18.2'' D x 40'' H) Weight: 15 Kg (33 lbs) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC
The provided document is a 510(k) Premarket Notification from the FDA for the InMode RF System. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device (ThermiGen Symphony RF System, K130689).
However, this document does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. Instead, it focuses on the performance of a radiofrequency medical device for electrocoagulation and hemostasis through bench testing and ex-vivo studies, comparing it to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details for an AI/ML powered device, ground truth establishment, or multi-reader multi-case studies from this document. The document describes a traditional medical device clearance process, not one for an AI/ML based diagnostic or treatment device.
To answer your request, if this were an AI/ML powered device, the information would typically be found in detailed clinical study reports or regulatory submissions specifically addressing the performance of the AI algorithm.
§ 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.