(269 days)
The BTL-754 device with BTL-754-4 handpiece has the following indications for use:
The 2940nm Fractional handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540nm Fractional handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The combined 1540mm and 2940mm Fractional handpiece is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The BTL-754 is a medical device containing two laser wavelengths. A laser is a device that can generate light in the visible or invisible part of the electromagnetic spectrum. The generation of radiation occurs by means of so-called stimulated emission, thanks to which its beam has specific properties - the laser beam is well directed and can propagate over long distances without much divergence. It can also be focused into a very small spot where a very high intensity is achieved.
The BTL-754 consists of a main unit, articulated mirror arm and applicator. The main unit is equipped with a color touch screen with a wide that makes the device easy to use. The onscreen information informs the operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about therapy parameters. The device is equipped with the Emergency laser stop button for immediate termination of the laser emission.
The provided FDA 510(k) summary for the BTL-754 device does not describe a study involving an AI/Machine Learning component, nor does it specify acceptance criteria for such a system.
Instead, the document details a medical device (a laser surgical instrument) and its substantial equivalence to a predicate device. The "Non-clinical Testing" section refers to compliance with applicable medical device safety standards and basic device performance verification, typical for hardware medical devices, not AI/ML performance. The "Clinical Testing" section explicitly states "Not applicable to this submission".
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them, as the provided text does not contain any reference to AI/ML device performance or associated studies.
The information provided is geared towards demonstrating the BTL-754 is substantially equivalent to a legally marketed predicate device (Palomar Icon Aesthetic System, K142376) based on intended use, technological characteristics, and safety standards for laser surgical instruments.
§ 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.