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The Oculase MD is indicated for use in general ophthalmic soft tissue surgical indications such as: incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

The Oculase MD Er,Cr:YSGG (Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet) tissue cutting system is a unique device with diverse ophthalmic tissue applications. A flexible fiber optic with handpiece delivers the laser wavelength to the target tissue. A red light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output may be adjusted to specific user requirements for tissue applications. Laser radiation is delivered from the laser unit to the handpiece through the optical fiber. A sterile water spray is emitted at the same time laser radiation is delivered to the tissue site. The handpiece is rotatable and detachable from the optical shaft. The tip is detachable from the handpiece and serves as the optical power conduit to the target tissue.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Oculase MD, dated July 5, 2006. It describes the device, its indications for use, and its substantial equivalence to predicate devices. Crucially, the document explicitly states under the section "6. Performance Data": "None presented."

Therefore, based on the provided text, there is no information regarding acceptance criteria or a study proving the device meets acceptance criteria. The device's clearance was based on substantial equivalence to predicate devices, not on performance data from a specific study.

As such, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as this information is not present in the given text.

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