(29 days)
UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
The Momentum is a self-contained compact laser light source that operates on standard AC supply power requiring no special power or cooling considerations. A protective interlocked housing encloses the laser source, electronics, and gas storage and distribution system. The XTRAC Momentum Model AL10000 comes in two spatial configurations: a horizontal (Velocity)configuration and a vertical (upright / Momentum) configuration.
A core element of both the Momentum excimer laser and the Velocity is a sealed chamber containing a mixture of pressurized Neon, Xenon, and HCl gases. High-voltage electrical discharges into the gas mixture create unstable XeCl molecules, which dissociate rapidly, creating monochromatic ultraviolet light at a wavelength of 308 nm. The electrical discharges are repeated in a fast sequence, producing a train of light pulses of a nominal duration of 30ns each. The timing of electrical discharges and energy of the produced light are constantly monitored by an on-board microprocessor to ensure safety.
Using a set of optical devices such as mirrors, shutters, lenses, and optic fibers, the produced light is focused and directed by the user to skin areas affected by disease. Each dose delivered by the system is composed of multiple laser pulses delivered at a preset repetition rate for a duration that is managed by the system processor.
The provided text does not describe acceptance criteria or a study proving that a device meets such criteria.
Instead, the document is an FDA 510(k) clearance letter for the XTRAC Momentum Excimer Laser System, Model AL10000. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (XTRAC Velocity Excimer Laser System, Model AL10000), rather than proving performance against specific acceptance criteria through a clinical study.
The document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- "No mechanical, animal or clinical testing was performed."
- "The performance testing has demonstrated that the subject devise met the applicable standard performance requirements. The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent."
Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, etc.) from this document, as the clearance was not based on a clinical study designed to prove the device met specific performance acceptance criteria. The clearance was based on demonstrating the new device is as safe and effective as an already cleared device through comparison of technological characteristics and non-clinical performance testing (biocompatibility, electrical safety, EMC, software verification/validation).
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.