BAYERS BIMANUAL I/A HANDPIECES

• K Number: K971064
• Device Name: BAYERS BIMANUAL I/A HANDPIECES
• Manufacturer: VISION CARE DEVICES, INC.
• Date Cleared: 1997-06-09 ( 77 days)
• Product Code: HQC
• Regulation Number: 886.4670
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Anterior Phaco emulsification cortex clean up.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Bayers Bimanual I/A Handpieces." This document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria as one might find for a novel or higher-risk device requiring a PMA.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.