(90 days)
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
- The 1064nm wavelength of the PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
- The 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick skin types I-III.
The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software.
The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser energy.
After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.
The provided text is a 510(k) summary for the PICOSECOND Nd:YAG Laser System (PICO PREMIUM). It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not describe a clinical study with human subjects, nor does it present acceptance criteria and performance metrics in the context of an AI/algorithm-based diagnostic or therapeutic device.
The "Performance Data (Non-clinical)" section (Page 6, Section 8) explicitly states that "All acceptance criteria were met," but these listed criteria are for engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993 for biocompatibility, and FDA guidance for software verification and validation). These are not performance metrics related to diagnostic accuracy, sensitivity, specificity, or the improvement of human reader performance, as would be expected for an AI-enabled device that requires such rigorous clinical validation.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based device and its clinical performance. The provided document concerns a laser system device that is evaluated against established safety, electrical, and biocompatibility standards, not an AI or algorithm that would undergo the type of performance evaluation you've outlined.
Based on the provided document, the following information is either not applicable or not available:
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A table of acceptance criteria and the reported device performance: The acceptance criteria mentioned are engineering standards (e.g., IEC, ISO) and the document states they "were met." No specific quantitative performance data for the device's clinical effectiveness (e.g., in terms of tattoo removal efficiency or safety in human subjects against specific metrics) is provided in a comparative table.
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Sample sizes used for the test set and the data provenance: No test set for clinical performance is described. The "test set" here refers to the engineering tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth establishment is described.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not mentioned. The device is a laser system, not a diagnostic AI that would typically undergo such a study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: Not applicable.
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The sample size for the training set: Not applicable, as there's no mention of an algorithm 'training set'.
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How the ground truth for the training set was established: Not applicable.
The document's purpose is to demonstrate substantial equivalence to a predicate laser device based on technical characteristics and compliance with safety and performance standards, not clinical efficacy measured through a study design typically associated with AI/ML products.
§ 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.