(198 days)
The Bioptron Pro and Bioptron Compact III Light Therapy Systems is indicated for adjunctive use in providing temporary relief of is includied for dejaried shoulder pain of musculoskeletal origin.
Not Found
I am sorry, but based on the provided document, the information required to answer your request is not present. This document is a 510(k) clearance letter from the FDA for a light therapy system, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not contain details about:
- Specific acceptance criteria with numerical targets.
- A study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Standalone algorithm performance.
- The type of ground truth used.
- Training set details (sample size, ground truth establishment).
Therefore, I cannot fulfill your request for this specific input.
§ 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.