ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

• K Number: K994015
• Device Name: ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
• Manufacturer: SURGIN SURGICAL INSTRUMENTATION, INC.
• Date Cleared: 2000-03-15 ( 110 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the Surgin AccuBlade™ Microkeratome Blade, which primarily focuses on regulatory approval based on substantial equivalence to existing devices. It does not contain information about specific acceptance criteria for device performance, the details of a study that proves the device meets those criteria, or any of the other requested information regarding sample sizes, ground truth establishment, or clinical study methodologies.

Therefore, I cannot provide the requested table and study details from the given text. The document is a regulatory approval notice, not a clinical study report.

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.