(255 days)
The Alma Lasers Harmony XL™ Multi-Application Platform is intended for use in dermatologic and general surgical procedures. The Harmony XL™ Multi-Application Platform is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
The Alma Lasers Harmony XL™ Multi-Application Platform is comprised of the following main components: The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer. Variety of handpieces and attachment accessories. Footswitch.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Harmony XL™ Multi-Application Platform, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and a study to meet them.
The text outlines:
- General information about the device and submitter.
- A list of predicate devices.
- A product description.
- Extensive indications for use for various modules and handpieces in dermatologic and general surgical procedures.
- A rationale for substantial equivalence.
- A conclusion of substantial equivalence.
It does not contain details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
This document is a regulatory submission for substantial equivalence, not a scientific publication detailing performance studies against specific acceptance criteria.
§ 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.