GAUZE, SPONGES, CAT # 11-003

• K Number: K983016
• Device Name: GAUZE, SPONGES, CAT # 11-003
• Manufacturer: VITALCARE GROUP, INC.
• Date Cleared: 1999-02-12 ( 168 days)
• Product Code: EFQ
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Wound cover for patient care.

Device Description

Gauze, Sponges Various Sizes, Non-Sterile and Sterile

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding "Gauze Sponges." This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific information regarding a study, as this information is not present in the provided text. The document is simply an FDA clearance for a medical device (gauze sponges) that was deemed substantially equivalent to existing devices, without the need for the types of performance studies you are asking about for AI/ML products.

Regulation Number and Section

N/A