PRIZM KERATOME BLADE, MODEL MK8512M2

• K Number: K033236
• Device Name: PRIZM KERATOME BLADE, MODEL MK8512M2
• Manufacturer: SURGIN SURGICAL INSTRUMENTATION, INC.
• Date Cleared: 2004-03-26 ( 172 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The Prizm Keratome Blade VII is to be used as a replacement blade for the blade in the non-disposable Moria M2 keratome for lamellar resection of the corner.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a medical device called "Prizm Keratome Blade VII," indicating that the device has been found substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about any specific study (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

The letter primarily focuses on the regulatory clearance process and states the device's indications for use based on its substantial equivalence to an existing product. It does not elaborate on the specific performance metrics or studies conducted to demonstrate that equivalence or to establish performance against acceptance criteria.

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.