(25 days)
LiteCure Therapy Compact (Model LTC-900 and LTC-1200) is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
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The provided text is a 510(k) summary from the FDA for a medical device called "Litecure Therapy Compact." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about AI algorithms, sample sizes for training/test sets, expert involvement, or adjudication methods.
The document is a letter confirming the substantial equivalence of the Litecure Therapy Compact (Models LTC-900 and LTC-1200) to legally marketed predicate devices, a necessary step for FDA clearance. It lists the indications for use, which are to provide topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. That information is not present in the provided document.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.