(232 days)
The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
The provided text does not describe a study involving acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it is an FDA 510(k) summary for a medical device called "AVACEN 100," which is a heat therapy system.
This document focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Anpan FIR Heat Therapy Systems) for regulatory clearance. It outlines the device description, indications for use, comparison with the predicate device, and compliance with nonclinical safety standards (electrical safety, electromagnetic compatibility, and biocompatibility).
Therefore, I cannot provide the requested information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, or multi-reader multi-case studies, as none of this pertains to the content of the provided document. The device in question is a physical heat therapy system, not an AI/ML algorithm.
§ 890.5740 Powered heating pad.
(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.