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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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The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.

Bladeworks Microkeratome Blade

This letter is a 510(k) clearance letter from the FDA for a medical device (Bladeworks Microkeratome Blade). It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, or study design.
3. Information on experts, ground truth establishment, or adjudication methods.
4. Mention of any multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Details on standalone algorithm performance studies.
6. The type of ground truth used in such studies.
7. Sample size for a training set or how its ground truth was established, as these are typically relevant for AI/ML device studies, which this device pre-dates.

The letter focuses on regulatory clearance, not on a detailed scientific study. Its main purpose is to confirm substantial equivalence and allow the device to be marketed.

Ask a specific question about this device

Ask a specific question about this device