MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB

• K Number: K022716
• Device Name: MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
• Manufacturer: MED-LOGICS, INC.
• Date Cleared: 2002-10-11 ( 57 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The Med-Logics 7020CLB microkeratome blades are to be used as replacement blades for the Moria C-B™ microkeratome.

Device Description

Microkeratome Blade

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a medical device (Med-Logics Model 7020CLB™ Microkeratome Blade). This type of document is an approval letter for a device that has demonstrated substantial equivalence to a predicate device, not typically a report of a new study designed to prove acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, especially with details like sample size, ground truth, and expert adjudication, is not present in this document.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

This means the approval is based on demonstrating equivalence, not on a new clinical study with acceptance criteria for device performance as a novel invention.

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

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.