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The Domier Lasertrode fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes, or for open surgery for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Dornier Lasetrode is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT and General Surgery.

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The provided text is a 510(k) summary for the Dornier Lasertrode Fiber, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with acceptance criteria, test sets, or expert evaluations. Therefore, the document does not contain information regarding acceptance criteria, device performance from a new study, sample sizes, ground truth establishment, or clinical effectiveness studies in the way you've described.

Instead, the submission argues for substantial equivalence based on technological characteristics and intended use being the same as the predicate device (Dornier Light Guide with Bare Fiber Tip, K982629).

Here's why the requested information cannot be extracted from this document:

• No new clinical study: The document explicitly states, "The safety and effectiveness of the Dornier Lasertrode is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices..." This means no new clinical trials were conducted to establish performance against acceptance criteria for this specific 510(k) submission.
• Focus on substantial equivalence: The core of a 510(k) is to show that a new device is "substantially equivalent" to one already on the market. This often involves comparing design, materials, intended use, and performance data from previous studies on the predicate device, or bench testing to show similar performance, but not typically a new, large-scale clinical trial with acceptance criteria for the new device itself.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and expert opinions because the provided 510(k) summary does not contain this information for the Dornier Lasertrode Fiber.

The document's statement: "Dornier Surgical Products, Inc. believes the minor differences of the Dornier Lasertrode fiber and its predicate laser accessories should not raise any concerns regarding the overall safety or effectiveness" further supports this, indicating a comparison rather than a de novo performance evaluation.

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