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The SmartLite D is indicated for ablation, incision, excision, coagulation and vaporization of tissue in ophthalmology, dermatology, ENT & dentistry.

The SmartLite D laser device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue, in ophthalmology, ENT, and dermatology. In addition, the laser is intended for application in dentistry including:

• Frenectomy .
• Treatment of Oral Mucous Cysts .
• Treatment of Benign Vascular Lesions .
• Photocoagulation of Superficial Vessels .
• Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels ●
• Treatment of Superficial Tongue Lesions .
• Tissue Management and Hemostasis for Crown and Bridge Impressions ◆
• Incision and Drainage for Abscess .
• Gingivoplasty / Gingivectomy .
• Hemostasis during Dental Procedurcs .
• Operculectomy (Operculotomy) .
• Excisional Biopsy .
• Free Gingival Graft (Adjunct) .
• Vestibuloplasty .
• Soft Gutta Percha .
• Treatment of Canker sores, Herpetic Lesions, and Aphthous Ulcers
• Laser-assisted Bleaching / Whitening of the Teeth .

SmartLite D is a frequency doubled Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 532 nm. Laser activation is by footswitch. Overall weight of the laser is 10 Kg and the size is 27x26x36 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

This 510(k) premarket notification for the Cynosure SmartLite D Laser does not include acceptance criteria or a study demonstrating the device meets such criteria because it is a traditional medical device (a laser system), not an AI/ML-powered device.

The provided document is a 510(k) summary for a medical laser system. For traditional medical devices like this, the demonstration of safety and effectiveness typically relies on substantial equivalence to a predicate device, as opposed to performance metrics against acceptance criteria derived from clinical studies or AI algorithm evaluation.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. Performance is assessed by demonstrating equivalence to a predicate.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm here.
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 for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
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 consensus, 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.

Instead, the relevant information for this 510(k) submission is:

• Nonclinical Performance Data: "none"
• Clinical Performance Data: "none"
• Comparison: "The SmartLite D laser has an equivalent indication for uses, the same principle of operation, the same wavelength and essentially the same pulse energy range as the predicate devices."
• Predicate Device: Fisma Elite Family of Lasers (frequency doubled Nd:YAG), Fisma Dental 200, Dental 300, Dental 400.

The FDA's decision to clear this device (K040289) was based on its determination of "substantial equivalence" to a legally marketed predicate device, as stated in the letter from the FDA. This means the device was found to be as safe and effective as the predicate device already on the market, based on similar indications for use, principle of operation, wavelength, and pulse energy range, rather than a specific performance study against defined acceptance criteria.

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