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The Vari-Lase® 90W laser console is indicated for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) and in contact mode, for the vaporization, ablation, incision, and excision of soft tissue.

The Vari-Lase® procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

The Vari-Lase 90 Watt Endovenous Laser Console (Vari-Lase Console) is a software controlled diode laser that provides an output wavelength of 810mm. It may be used in conjunction with a cooling system in certain surface treatment applications.

The provided text is a 510(k) summary for the Vari-Lase® 90 Watt Endovenous Laser Console. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states:

"No additional testing was completed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study or testing was conducted or reported in this document. The device's approval seems to be based on its substantial equivalence to previously cleared devices and compliance with relevant medical electrical equipment standards.

Here's a breakdown of why each requested point cannot be addressed from the given input:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided for this specific device. The summary only lists standards with which predicate devices (and by extension, this device through equivalence) are compliant.
2. Sample size used for the test set and the data provenance: No test set or associated data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set or ground truth established for this device.
4. Adjudication method 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: Not applicable. This device is a laser console, not an AI diagnostic tool involving human readers.
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 as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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