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The Auriga QI laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The Auriga QI is a holmium laser system, which emits laser radiation with a wavelenath of approximately 2,1 um. Optical laser power is transferred via an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of: laser system including control panel (user interface), foot switch, application fiber.

The provided 510(k) summary for the Auriga QI laser system does not include acceptance criteria or a study that evaluates the device's performance against such criteria. The document explicitly states:

"No clinical information is required."

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Auriga XL, K111475) through laboratory testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Here's a breakdown of why each specific point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions "all design specifications" were met through laboratory testing, but no specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not provided. Only "laboratory testing" is mentioned, without details on sample sizes or data origin.
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 clinical study requiring expert ground truth for a test set.
4. Adjudication method for the test set: Not applicable for the same reason as above.
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 system, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical data or ground truth establishment is described for performance evaluation.
8. The sample size for the training set: Not applicable for a traditional medical device submission that does not involve machine learning or AI.
9. How the ground truth for the training set was established: Not applicable.

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