(106 days)
The THL1 Laser is indicated for use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
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This document is a 510(k) clearance letter from the FDA for a medical device (Erchonia® THL1 Laser). It states that the device is substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving device performance.
A 510(k) submission typically includes a summary of performance data, but the full study details, acceptance criteria, sample sizes, ground truth establishment, and MRMC study results are not usually part of the public-facing clearance letter. These are found in the original 510(k) submission document itself, which is often much more extensive.
Therefore, based only on the provided text ({0}, {1}, {2}), I cannot provide a table of acceptance criteria, reported device performance, or details about the study. The document primarily focuses on the regulatory clearance and indications for use.
To answer your questions, I would need access to the actual 510(k) submission (K100509) or its summary, which would include the clinical or performance data that supported the substantial equivalence claim.
§ 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.