(35 days)
The Erchonia PL5000 laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them.
The document is an FDA 510(k) clearance letter for the Erchonia PL5000 device, indicating that the device has been found substantially equivalent to a predicate device. It specifies the "Indications for Use" for the device (temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin).
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study proving the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- How ground truth for training data was established.
This document is a regulatory approval notice, not the detailed study report or clinical trial results that would contain the information you are seeking.
§ 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.