(81 days)
BTL 799-2T is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
· Strengthening, Toning and Firming of buttocks and thighs.
· Improvement of muscle tone and firmness, for strengthening muscles in arms.
The BTL 799-2T is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device two outputs enable simultaneous treatment by two applicators.
The BTL 799-2T is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
This document is a 510(k) Summary for the BTL 799-2T device, indicating that it is a powered muscle stimulator regulated under 21 CFR 890.5850. The summary primarily establishes substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/ML device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance study results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on the regulatory pathway of substantial equivalence, which primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing (e.g., electrical safety, electromagnetic compatibility, usability, risk management, biocompatibility) rather than a clinical performance study with specific quantitative performance metrics as would be expected for an AI/ML device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).