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The Blade Works 7061 microkeratome blades are to be used as replacement blades for the Moria LSK-One microkeratome, to perform lamellar keratectomy procedures.

Blade Works Microkeratome Blade, Model 7061

This document is a 510(k) premarket notification approval letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement for a clinical study.

The letter explicitly states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was approved based on its similarity to an existing device, not on a new clinical study proving against acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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