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510(k) Data Aggregation
(168 days)
Powered Muscle Stimulator (Model name:MagGraver F200)
Powered Muscle Stimulator (Model name:MagGraver F200) 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.
Powered Muscle Stimulator (Model name:MagGraver F200) is a non-invasive therapeutic device. The device produces electromagnetic field that stimulates the tissues of the human body, the device helps to strengthen, tone, and firm the abdomen and buttocks by stimulating muscle.
The device has two output channels and two applicators, one applicator (Form A) is applicable for abdomen and another (Form B) is applicable for buttocks. The applicator can plug in either output channels. The two outputs of device enable simultaneous treatment by two applicators.
The Form A applicator consists of round coil and cooling system. The Form B applicator consists of figure-of-eight coil and cooling system.
There is a pressure kit is used to monitor abdomen muscle contraction by monitor the pressure between applicator and abdomen, the pressure kit is only used with Form A applicator.
The device is equipped with a color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The screen angle can be adjusted.
I'm sorry, but this document does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter and summary for a Powered Muscle Stimulator (MagGraver F200). While it addresses device safety and effectiveness in comparison to a predicate device, it does not describe:
- Acceptance criteria for an AI/algorithm-based device and reported performance against those criteria. This device is a physical electromedical device, not an AI/algorithm-based diagnostic or therapeutic tool.
- Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the validation of AI/ML models, which is not the subject of this document.
- Ground truth establishment or training set details. Again, these relate to AI/ML model development and validation.
The primary performance data presented relates to non-clinical bench testing of the magnetic field intensity and pulse characteristics, and compliance with general medical device standards (e.g., IEC 60601-1 for safety). There is no mention of a performance study proving the device meets acceptance criteria related to AI/ML.
Therefore, I cannot extract the requested information from the provided text.
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