BLADEWORKS MICROKERATOME BLADE

• K Number: K993225
• Device Name: BLADEWORKS MICROKERATOME BLADE
• Manufacturer: BLADE WORKS, INC.
• Date Cleared: 2000-03-20 ( 175 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K000000

Intended Use

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.

Device Description

Bladeworks Microkeratome Blade

AI/ML Overview

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.

Regulation Number and Section

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.