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The MegaBeam Endocular Probe and Aspirating Endocular Probe are intended for intraocular photocoagulation with or without simultaneous aspiration/ irrigation as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, tractional retinal detachments, proliferative diabetic retinopathy, and various retinal vascular tumors.

The MegaBeam Endocular Probe and Aspirating Endocular Probe for Biolitec Medical Devices. Inc. contains the same components and design as the devices cleared under K935747 and K952340 for Biolitec Inc. except for a small change in tip size. (19 gauge to 25 gauge).

The provided text explicitly states that no performance testing was included in the submission for the MegaBeam Endocular Probe and Aspirating Endocular Probe. The submission relies on the established and documented performance of its predicate devices due to similar components, design, and only a small change in tip size (19 gauge to 25 gauge).

Therefore, there is no information available in the provided document to answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment for this particular device submission.

The relevant sentence is: "Since the performance of the MegaBeam Endocular Probe and Aspirating Endocular Probe is well established and documented no performance testing is being specifically included in this submission."

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