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The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for wind regally subsequent ophthalmic surgical manipulation.

OptiPoint Corneal Template

This document is a 510(k) clearance letter from the FDA for the OptiPoint Corneal Template, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have described above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means that the device was cleared based on its substantial equivalence to a predicate device, rather than a clinical study proving its performance against specific acceptance criteria in the way you've outlined.

To answer your questions, I would need access to the actual 510(k) premarket notification document or a clinical study report for the OptiPoint Corneal Template, which is not provided in the given text.

Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies based solely on this FDA clearance letter.

Ask a specific question about this device