(131 days)
The Muscle Stimulator Device 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, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
The Muscle Stimulator Device (model PZ-100) is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has four outputs, and two applicators perform simultaneous treatment.
The Muscle Stimulator Device 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 step-by-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.
The Muscle Stimulator Device is composed of control display panel module, main control module, temperature module, treatment handle module, and fan cooling module.
The proposed device can simultaneously apply multiple treatment handles to patients, and the handles are held in place by bandages.
This document is a 510(k) clearance letter for the Muscle Stimulator Device (PZ-100). It focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of specifications.
Crucially, there is ABSOLUTELY NO MENTION of acceptance criteria related to a study proving performance, sample sizes, expert involvement, ground truth, or MRMC studies.
The document explicitly states:
- "No clinical study is included in this submission." This means there was no study to prove the device met acceptance criteria in a clinical setting with human subjects.
- The clearance is based on "non clinical tests" to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These typically involve engineering tests, electrical safety, EMC, and biocompatibility, as listed in the "Non-Clinical Test Conclusion" section.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for proving the device meets those criteria because this information is not present in the provided document.
The document describes regulatory compliance and equivalency based on technical specifications and non-clinical testing, not on a clinical performance study with human subjects, which would typically involve the criteria you asked about (sample size, expert ground truth, MRMC, etc.).
In summary, based on the provided text, the device was NOT proven to meet acceptance criteria through a clinical performance study. Its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical testing.
§ 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).