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The Dornier Medilas H/2 Laser is intended to be used in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparascopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non-contact open surgery (with or without hand piece).

The Dornier Medilas H/2 Laser is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Lithotripsy, Gastroenterology, Gynecology, ENT, and General Surgery.

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I am sorry, but the provided text is a 510(k) summary for a medical device (Dornier Medilas H/2 Laser) and does not contain the kind of study information (acceptance criteria, sample sizes, expert qualifications, ground truth, etc.) that you are asking for.

The 510(k) summary focuses on establishing "substantial equivalence" of the new device to a predicate device already on the market, rather than presenting a performance study with detailed acceptance criteria and study data. It primarily discusses:

• Device Name, Submitter, and Contact Information: Basic identification details.
• Classification Name and Predicate Devices: How the device is categorized and which existing device(s) it is compared to for regulatory purposes.
• Intended Use and Indications for Use: What the device is designed to do and for which medical conditions/procedures. In this case, it's for cutting, vaporization, ablation, and coagulation of soft tissue in various surgical specialties.
• Technological Characteristics and Substantial Equivalence: The core of a 510(k), where the manufacturer argues that their new device is similar enough to an already legally marketed device (the predicate) that it does not raise new questions of safety or effectiveness. The key point here is that the only minor difference mentioned is the replacement of a contraindication with a precaution statement regarding kidney and bladder stone fragmentation.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a clinical study report or a pre-market approval (PMA) application summary, which typically include detailed performance data, acceptance criteria, and study methodologies.

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