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The Smart 2940 D laser is indicated for intraoral soft tissue surgery including dental soft tissue.

Smart 2940 D is an Er:YAG laser, having a flashlamp pumped, Erbium rod as the lasing medium. It is a laser with a wavelength of 2,940 nm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.

The provided text is a 510(k) summary for the Cynosure Smart 2940 D laser. It directly states that no nonclinical or clinical performance data was provided. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them from the given document.

The submission relies on substantial equivalence to a predicate device (PhotoDent laser) for its market clearance, rather than presenting new performance data.

Here's a breakdown of why I cannot fulfill your request based on the provided input:

1. A table of acceptance criteria and the reported device performance: Not available. The document states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no test set data was provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set data was provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data was provided.
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: Not applicable. This device is a laser for surgery, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser for surgery, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for performance data in this submission.
8. The sample size for the training set: Not applicable, as no training set data was used for performance evaluation in this submission.
9. How the ground truth for the training set was established: Not applicable, as no training set data was used for performance evaluation in this submission.

In summary, the provided document explicitly states that no performance data (nonclinical or clinical) was submitted. The clearance was based on substantial equivalence to a predicate device, meaning the new device shares fundamental technological characteristics and intended uses with an already legally marketed device.

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