(410 days)
The MTX-C1 is intended for the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
The MTX-C1 main unit is a RF(Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch.
The main unit can be used with 3 different types of handpieces for treatment.
The system consists of ;
- Main unit
- 3 type treatment handpiece
- Footswitch
-
- Touch screen(User interface)
The three treatment handpieces differ in size and configuration and are indicated for the treatment of various size areas.
The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit.
The handpiece is applied with a rubbing/massaging technique and the applicator should be moved continuously on the skin.
- Touch screen(User interface)
This document is a 510(k) summary for the MTX-C1 device, seeking a substantial equivalence determination to a predicate device (Venus Legacy CX). It primarily focuses on demonstrating equivalence through comparison of technological characteristics and adherence to safety standards, rather than proving diagnostic performance against a specific set of acceptance criteria in a clinical study.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets) is not present in this document.
The document details the following about the device and its testing:
- Device Name: MTX-C1
- Intended Use: Relief of minor muscle aches and pain, relief of muscle spasm; temporary improvement of local blood circulation; temporary reduction in the appearance of cellulite.
- Predicate Device: Venus Legacy CX (K143554)
- Testing Performed:
- Biocompatibility testing: Patient contact components and materials tested and validated according to ISO10993-1.
- Non-Clinical testing (Safety Standards):
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories)
- Performance bench testing: The three handpieces of MTX-C1 were tested to achieve superficial skin temperature (40 - 45°C) and maintain it for the required therapy time. This demonstrated that the device "can achieve therapeutic parameters substantially equivalent to the currently cleared predicate device for the intended use."
The document states that "The technological differences... do not alter the device's core technology or performance and have been addressed by the manufacturer through the applicable safety standards... and through non-clinical performance bench testing (Skin temperature)." This strongly suggests that a clinical performance study with human subjects, as would be typical for an AI/CAD device, was not required or conducted for this 510(k) submission, as the substantial equivalence was established through technical and safety testing.
In summary, none of the specific criteria related to clinical study design, ground truth establishment, or human/AI performance metrics (points 1-9 in your request) can be extracted from this document, as it outlines a 510(k) submission primarily based on technological equivalence and adherence to safety standards for an electrosurgical device, not a diagnostic 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.