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The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy .
• Urology
• Lithotripsy
• Pulmonology
• Gastroenterology
• Gynecology
• ENT .
• General Surgery

The Solvo is a modification to Dornier's Medilas H20 Laser K061455.

The provided text describes a 510(k) summary for the Medilas H Solvo Holmium Laser, which is a modification of an existing device. This document is a regulatory submission for substantial equivalence and does not contain any information regarding clinical studies or device performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device.
• Identifying the predicate device.
• Stating the intended use and indications for use.
• Asserting substantial equivalence to the predicate device based on design specifications and technological characteristics, without presenting any new performance data.

The FDA's letter (Sections 2 and 3) acknowledges the 510(k) submission and confirms that the device is substantially equivalent for the stated indications for use, subject to general controls. It does not refer to any performance data or clinical studies in this context.

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