(88 days)
The device is intended for treatment of benign vascular and benign pigmented lesions.
585 is a diode laser device used mainly for dermatology. It includes a main panel with the touch screen display, the optical fiber connector (SMA 905) and the status LEDs. On the rear panel the connectors for footswitch, remote interlock and power supply cable are located. The key switch and the emergency knob are located on the upper part of the device. The laser system is composed of an opto-mechanical block containing the laser source and heat dissipation system, aiming beam, control system and power electronics. The power electrical system is composed of a power supply. The control electronics, based on a microcontroller, manages power electronics, thermalization of the laser source and controls the user interface. Emission is triggered by means of a footswitch.
This FDA 510(k) summary provides information for a laser surgical instrument (585) for dermatological use. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met, especially in the context of an AI/algorithm-based device.
The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device. This means the performance data supplied is primarily related to the physical and electrical safety and characteristics of the laser, not the analytical or clinical performance of an AI model.
Here's a breakdown of why and what information is missing:
- No AI/Algorithm Component: The device described (Quanta System S.p.A. 585) is a physical laser surgical instrument. There is no mention of it containing any AI, algorithm, or software that performs diagnostic, prognostic, or treatment planning functions requiring a "test set," "ground truth," "experts," or "MRMC studies." The "Software Verification and Validation Testing" mentioned refers to the control software for the laser device itself, not an AI component analyzing images or data.
- Performance Data Type: The "Performance data" section refers to:
- Safety and electromagnetic compatibility (EMC): Compliance with IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-2-22, and IEC 60825-1). This is about the electrical and physical safety of the laser, not its analytical performance in identifying lesions.
- Software Verification and Validation Testing: This pertains to the internal control software of the laser device, ensuring it operates correctly, not an AI model.
- Biocompatibility: Established based on predicate devices, ensuring materials are safe for biological contact. This is also not related to AI performance.
- Substantial Equivalence: The primary argument for approval is "substantial equivalence" to existing laser devices, meaning it has similar intended use, indications for use, and technological characteristics (laser type, wavelength, pulse width, frequency, spot size). This comparison doesn't involve AI performance metrics.
Therefore, I cannot populate the table or answer the specific questions you've asked because the provided document does not describe an AI or algorithm-based device, nor does it contain the type of performance study details requested.
To answer your questions, I would need a 510(k) summary or an FDA approval document for a medical device that incorporates an AI or algorithm component for which clinical performance data, ground truth establishment, and expert review are relevant.
§ 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.