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PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leg due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.

The Heating Lumbar Therapy Cushion is a portable TENS/PMS device is equipped with a remote control, an adapter, a pair of electrode pads and electrode wire. The electrode wire is used to connect the electrode pads to the main unit.

The device has 5 stimulate modes and one heating mode, through the stainless steel plate to provide users with lower back stimulation and heat generation to warm and comfortable lower back muscles. In addition, it is equipped with a pair of electrode pads, which can be used to stimulate different parts of the body (the shoulder, waist, back, arm and leg).

The principle of operation of the subject device is:

PMS: A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. This device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

TENS: The electrodes placed on the skin send small-scale, low-voltage electrical pulses to specific nerves. The purpose is to change the way neurons send signals and prevent pain signals from reaching the brain to relieve pain.

All the functions of the device can only be controlled by the remote control, which should connected to the main unit through a wire. The remote controller has the component of ON/OFF Key, Mode Selection key (left and right), Intensity Modification keys (increase and decrease) and an LCD screen. And the LCD screen can show stimulation mode, stimulation intensity, heating intensity and time remaining of an application mode. The device has 5 stimulation modes, each with 50 stimulation intensity and one heating Mode, heating mode has 3 levels, namely level 1 (37°C), level 2 (40°C), and level 3 (43°C).

The stainless steel plate provides users with lower back stimulation and heat to warm and comfort the muscles of the lower back. The stimulation function and heating function can be used separately or simultaneously. When used with a pair of electrode pads, it must be used simultaneously with the main unit stimulation mode, otherwise the electrode pads will be invalid.

The equipment has four models: AST-622, AST-622B, AST-623B, the four models differ only in appearance.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Heating Lumbar Therapy Cushion." It establishes substantial equivalence to predicate devices, thus allowing the device to be marketed. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through clinical trials or performance assessments that generate quantitative results against those criteria.

Instead, the document focuses on demonstrating that the device is "substantially equivalent" to existing, legally marketed predicate devices. This is achieved primarily through a comparison of technical specifications and performance characteristics, along with verification through non-clinical testing against relevant standards.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met in the format requested, as that type of information is not present in this document. The document confirms that non-clinical tests were performed to assure conformance with standards, but it does not report specific performance metrics or acceptance criteria for those tests in a table as requested.

The document explicitly states:

• "6.2 Discussion of Clinical Tests Performed: There were no Clinical Tests."

This means there's no clinical study described that would involve sample sizes, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of clinical outcomes or diagnostic accuracy.

The tables provided (Elements of Comparison) list various technical specifications and note whether they are "SE" (Substantially Equivalent) or provide a value for comparison. However, these are not pre-defined acceptance criteria in the sense of demonstrating a certain level of clinical performance or accuracy against a ground truth. They are comparisons to predicate devices to establish equivalence.

In summary, the provided document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets them, because it does not describe such a study.

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