(261 days)
The Aklarus Blue (420nm +/-10nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Aklarus combination of Red (628nm +/-10nm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
The Aklarus Anti-Aging Red (628nm +/-10nm) and Anti-Aging Infrared (880nm +/- 10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
The Alarus Infrared (880nm +/-10nm) is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
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The provided text is a 510(k) summary for the Aklarus Phototherapy System. It outlines the device's details, indications for use, and a comparison to predicate devices, concluding that it is substantially equivalent. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with defined acceptance criteria for novel performance claims. While the Indications for Use mention treating conditions like acne vulgaris, periorbital wrinkles, and pain relief, the document explicitly states: "The proposed Aklarus Phototherapy System when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the predicate devices listed in this section." This suggests that the substantial equivalence was likely based on comparison of technological characteristics and intended use to existing devices, rather than a new standalone clinical study with acceptance criteria.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided 510(k) summary.
If such a study had been conducted and included in the submission, significant details on its methodology, results against acceptance criteria, and statistical analysis would typically be found in a separate section of the 510(k) submission, often titled "Clinical Studies" or "Performance Data." This document only provides a summary demonstrating substantial equivalence based on predicates.
§ 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.