(270 days)
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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).