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The Tender Touch is intended to emit energy in the visible and infrared spectrum to provide heating for the purpose of elevating tissue temperature for the temporary relief of joint pain, muscle stiffness, minor arthritis pain or muscle spasm; the temporary increase in local blood circulation and the temporary relaxation of muscle.

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I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Sometech Corporation regarding the 510(k) premarket notification for their device, Tender Touch. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. It also includes the official indications for use for the Tender Touch device. This document does not provide details about acceptance criteria, study methodologies, or performance metrics.

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TENDER TOUCH™ Silicone Gel Pads are designed to be worn on the body to help reduce pressure and friction against bony prominences, and they can also be used as scar management. This is not a wound covering or dressing and is not sterile.

TENDER TOUCH™ Silicone Gel Pads are soft silicone gel sheets that are applied over bony prominences. The sheets are not made of medical grade silicone and are not sterile. The sheets are square and rectangular and come in three sizes, 9cm x 9 cm, 6 cm x 6 cm and 3.5 cm x 6 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. The pad helps reduce friction and pressure against the skin. They can also be used as scar management. The sheets are not for use on an open wound, are not sterile but can be washed. They can be used under casting and splints and can be cut to other shapes if necessary.

This 510(k) premarket notification for the K991478 "TENDER TOUCH™ Silicone Gel Pads" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The provided document is a 510(k) summary and the FDA's clearance letter, which focus on establishing "substantial equivalence" to a legally marketed predicate device, rather than detailed performance study results against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance metrics or studies.

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