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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.

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TENS(Transcutaneous Electric Nerve Stimulation):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(Powered Muscle Stimulation):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.

Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electrodes to be used with the device have already been cleared under K182111.

The electronic stimulatory module has the operating elements of an On/Off Switch, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging.

The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity, etc.

The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

This document is a 510(k) Premarket Notification from the FDA regarding a Muscle Stimulator device. It does not contain information about an AI/ML device or a study involving acceptance criteria for such a device against ground truth.

The document primarily focuses on demonstrating substantial equivalence of the new Muscle Stimulator device (YR-U80-PRO-MAX, YR-U80-PRO, YR-U8-PRO, YR-U8) to existing predicate devices (K143268 and K121719). The document details:

• Device Description: A portable, DC 3.7V battery-powered multifunction device offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS).
• Indications for Use: Temporary pain relief (TENS) and stimulating healthy muscles to improve/facilitate performance (PMS).
• Comparison to Predicate Devices: A detailed table comparing various technical parameters (e.g., power source, output modes, waveforms, electrical characteristics) of the new device with the predicate and reference devices.
• Non-Clinical Testing: Conformance to various electrical safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133-2, IEC 60601-1-11).
• Clinical Testing: Explicitly states, "No clinical testing was performed on the device."

Therefore, based on the provided text, I cannot extract the information required to answer your questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes, or expert adjudication, as these topics are not discussed in the context of this device's submission.

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Ask a specific question about this device