(293 days)
The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.
The DermaSCULPT Er:YAG Laser System [DermaSCULPT] unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The laser energy produced within the device is delivered to the tissue by means of Fiber Delivery System and specially designed Scanner, Handpieces, Tips and Adaptors. The user activates laser emission by means of a footswitch. The lamp power supply causes the flash lamp to light, causing the emission of an invisible infrared Er:YAG laser beam (2.94 microns). A visible white light pulsed beam from the flashlamp is used as an aiming beam. The laser beam passes through a partially reflecting mirror and then passes through the energy monitor, after which its power is measured. When all the pre-conditions have been satisfied and the READY button is pressed and the foot switch is depressed, the safety shutter opens and the laser beam is allowed into the delivery unit coupler. The electrical system is comprised of the laser power supply, the control unit, calibrator, control panel, key switch, emergency stop switch, and foot switch. The components of the laser power supply include a high voltage power supply and a high voltage trigger control board. The high voltage power supply uses the high voltage to illuminate the flashlamp. The control unit comprises a microprocessor board, accessory board and other components that it controls. The calibrator measures the transmittance of the fiber delivery unit. The handheld scanner module is an attachment to the fiber.
The provided text describes the DermaSCULPT Er:YAG Laser System, its intended use, and its comparison to predicate devices, but it does not contain details about a study that establishes acceptance criteria or proves the device meets those criteria with specific performance metrics.
The document is a 510(k) summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the way you've described for AI/algorithm performance.
Therefore, I cannot provide the information requested in your bullet points as the provided document does not contain it. The "Nonclinical Performance Data" section states: "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the DermaSculpt is substantially equivalent to its predicate device." and "Clinical Performance Data" states: "HOYA ConBio has established that the DermaSculpt performs as clinically intended and that no new issues of safety and effectiveness are introduced." These statements indicate that performance was reviewed for substantial equivalence, but they do not provide specific acceptance criteria or study results in the format you've requested.
If you have a document that describes specific studies with acceptance criteria for an AI/algorithm-based device, please provide that text.
§ 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.