(204 days)
The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
The Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device.
The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).
The provided document is a 510(k) summary for a Picosecond Laser System, which is a medical device for dermatological and surgical applications. It is not an AI/ML-driven device, nor does it involve a study aimed at proving the device meets acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity).
Therefore, I cannot extract information related to:
- A table of acceptance criteria and reported device performance in the context of AI/ML.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for AI/ML performance.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Stand-alone AI algorithm performance.
- Type of ground truth used for AI/ML.
- Sample size for the training set or how ground truth for the training set was established for an AI/ML model.
The document focuses on demonstrating substantial equivalence to a predicate device (PicoSecond Nd: YAG Laser System, K200116) through non-clinical testing and comparison of technical specifications. It highlights:
- Identical Intended Use & Indications for Use between the subject device and the predicate device.
- Comparable technological parameters such as wavelength, pulse duration, pulse energy, repetition rate, and spot size.
- Compliance with recognized electrical safety, EMC, laser safety, and biocompatibility standards.
- Software validation according to FDA guidance for moderate level of concern.
- Bench testing to ensure the device delivers set energy parameters within specifications.
The document explicitly states:
"No clinical study is included in this submission." (Section 8.0 Clinical Test Conclusion)
Given this, I cannot answer the request in the context of an AI/ML-driven device or study. The information provided pertains to a traditional medical laser system undergoing a 510(k) clearance process based on substantial equivalence, not a performance study of an AI algorithm 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.