(463 days)
Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Therapy EC and Therapy XT are made up of ergonomic equipment that is easy to use and operate. They have one infrared laser diode (808nm). Two optical fibers conduct the laser light emitted by each emitter. The optical power emitted is controlled by the electrical current in the laser diodes. Therapy EC and Therapy XT are designed to emit infrared laser light. Additionally, they are intended to be used by health care professionals such as physicians, nurses, and physical therapists, for adjunctive use in the temporary relief of hand of wrist pain associated with Carpal Tunnel Syndrome. Therapy EC and Therapy XT are consisted of components including handpiece holder, battery charging cable, battery, spacer (3 units), safety glasses, eye protector, and transportation case. The only part that touches the patient is the spacer. This component is made of polycarbonate and has the function of creating a safe distance between the Therapy tip and the patient's skin.
The provided FDA 510(k) summary for the "Therapy EC and Therapy XT" infrared lamps does not contain information related to acceptance criteria, device performance, or human subject studies.
The document states that "Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing." This means that the FDA cleared the device based on engineering and safety tests, and a comparison to a previously cleared predicate device, rather than explicit clinical efficacy studies for the specific device being submitted.
Therefore, I cannot provide a response to your numbered questions regarding acceptance criteria, study details, human subject data, or ground truth, as this information is not present in the provided text.
The "Non-clinical Performance Testing" section lists various IEC and ISO standards that the device complied with, focusing on laser safety, electrical safety, and software lifecycle processes. These are engineering and quality standards, not clinical performance metrics.
§ 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.