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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:

1. A table of acceptance criteria and reported device performance in the context of AI/ML.
2. Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for AI/ML performance.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies.
4. Stand-alone AI algorithm performance.
5. Type of ground truth used for AI/ML.
6. 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.

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