MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB

• K Number: K022982
• Device Name: MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
• Manufacturer: MED-LOGICS, INC.
• Date Cleared: 2002-11-15 ( 67 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The Med-Logics 7050CLB microkeratome blades are to be used, as replacement blades for the Moria M2™ microkeratome, to perform lamellar keratectomy procedures.

Device Description

Microkeratome Blade

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Med-Logics Microkeratome Blade, Model 7050CLB." This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm performance evaluation.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and may be marketed. It discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot provide the requested information such as:

• A table of acceptance criteria and reported device performance
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth for test sets
• Information on MRMC studies or standalone algorithm performance
• Training set details

This type of information would typically be found in the supporting documentation submitted with the 510(k) application, not in the FDA's decision letter itself.

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.