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K Number
K973693
Device Name
AQUA PATCH
Manufacturer
PCI TECHNOLOGY
Date Cleared
1997-12-18

(83 days)

Product Code
MGQ,MGO
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Dermal ulcers, superficial wounds, 1st and 2nd degree burns, donor sites, skin tears, radiation reactions (burns), protection around tube sites.

Device Description

Aqua Patch Hydrogel Dressing

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Precision Converters, Inc. regarding their "Aqua Patch" hydrogel dressing. This type of document is an approval letter for a medical device based on substantial equivalence to a predicate device, not a study report demonstrating acceptance criteria for an AI/ML powered device.

Therefore, the requested information about acceptance criteria and a study proving a device meets those criteria, including details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, cannot be extracted from this document.

This document specifically is an approval for a physical medical device (hydrogel dressing) and not a software or AI/ML device, which would typically involve the kind of performance studies you are asking about.

N/A