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585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal.

1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).

The Cynergy is a user selectable, multi wavelength laser, having both an organic dye and an Nd:YAG rod lasing medium. It is a pulsed dye laser with wavelengths of 585, 590, 595,600nm and an Nd:YAG laser with a wavelength of 1,064nm.

Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD).

Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.

The provided document is a 510(k) summary for the Cynosure Cynergy Laser. It describes the device, its intended use, and its substantial equivalence to a predicate device (Cynosure TriStar laser). However, it explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

Therefore, based on the provided text, there is no acceptance criteria or study data presented that proves the device meets any specific performance criteria. The clearance is based on substantial equivalence to a predicate device, not on new performance data demonstrating efficacy against defined acceptance criteria.

Without clinical or nonclinical performance data, the following requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not applicable as no test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a laser device, not an AI diagnostic tool, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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