(167 days)
The PTG-05 is intended for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Strengthening, toning and firming of buttocks & thighs.
- Strengthening, toning and firming of arms
The PTG-05 is a non-invasive therapeutic device. The device produces an electrical current that interacts with the tissues of the human body. The PTG-05 is intended to increase the musculature of the abdominals, buttocks, arms and thighs. The device is intended to be used with single-use electrodes from Zimmer MedizinSysteme GmbH (K140340) or equivalent. The output of biphasic and middle frequency currents for muscle stimulation with maximum 8 channels at a time allows to treat several treatment areas simultaneously.
For an efficient treatment the user is guided via user interface throughout the whole treatment. First, the user can select the treatment area with the device illustrating where to place the electrodes. The modules are automatically matched to the specific treatment area while highlighted in the color of the matching trunk cable of the module.
In the therapy screen, the user can select one of the 5 pre-set treatment protocols for each treatment region based on the training level of the patient.
During the treatment, an animation of the electrodes is shown in the screen that outlines if the protocol is in a "work-phase" which means a contraction phase or if the protocol is in a "relax-phase" which refers to a muscle relax phase.
Expert mode
In addition, all 4 modules can be split into 8 channels using "Expert mode" for a precise adjustment of the individual channels. This is ideal to set different intensities for the inner musculature than for the outer musculature of a specific treatment area, for example.
Link-mode
All of the modules can be linked together which enables the use of the remote control where the patient by itself can set the intensity and stop the therapy at any time.
The provided text is a 510(k) summary for the PTG-05 device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a clinical study proving device performance against such criteria. The "Performance data" section only mentions that testing for electrical safety, performance testing, biocompatibility, and usability were conducted satisfactorily, along with specific waveform measurements and adherence to consensus standards. It explicitly states: "All required performance tests were conducted and show substantial equivalence with the predicate device." This indicates technical performance testing, not clinical performance against acceptance criteria for the indicated uses (strengthening, toning, firming of muscles).
Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them in the way requested. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to safety and performance standards, rather than presenting a clinical study with acceptance criteria for the stated indications.
If this were a document providing clinical study results, the requested information would typically be found in sections describing clinical trials, performance goals, statistical analysis, and outcomes related to the stated indications for use (muscle tone improvement, strengthening, toning, firming).
§ 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).