(126 days)
The DioBeam 830™ is for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome
Not Found
The provided text is a 510(k) clearance letter for a medical device called DioBeam 830, which is a "Lamp, non-heating, for adjunctive use in pain therapy." This document primarily focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study demonstrating quantitative acceptance criteria and performance of the device itself.
Therefore, the input document does not contain the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on equivalence to existing devices, not necessarily on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for the DioBeam 830.
To provide the requested information, a clinical study report or a more detailed technical submission from the manufacturer would be required. The 510(k) clearance letter itself does not contain this level of detail about device performance studies.
§ 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.