(194 days)
The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.
The Axiom Bio Laser LLT Series - 1 is a single diode laser which produces an Output power of no more than 5 mW of energy with a 660 nm wavelength.
The provided 510(k) summary for the Axiom BioLaser LLLT Series-1 details regulatory information and declares substantial equivalence to a predicate device, the Erchonia PL2000. It does not contain information about acceptance criteria, device performance, clinical study design, or ground truth establishment.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
- The sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) summary explicitly states that the substantial equivalence is due to the technical aspects of both devices (Axiom BioLaser LLLT Series-1 and Erchonia PL2000) being "Significantly equivalent," leading to the "same treatment For the intended use of providing temporary relief of minor chronic neck And shoulder pain of musculoskeletal origins." This suggests FDA clearance was based on equivalence to a legally marketed predicate device rather than a new clinical study demonstrating specific performance metrics against acceptance criteria.
§ 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.