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K Number
K973688
Device Name
DUODERM CONTROL GEL FORMULA BORDER DRESSING
Manufacturer
CONVATEC LTD.
Date Cleared
1997-12-23

(88 days)

Product Code
FRO,MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K901155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue,

Device Description

The concept of DuoDERM CGF Control Gel Formula Border Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a wound dressing (DuoDERM CGF Control Gel Formula Border Dressing). This document details regulatory classification, indications for use, and substantial equivalence to a predicate device. However, it does not contain the type of performance study data and acceptance criteria typically found for diagnostic or AI-powered devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because the document does not describe such a study for this type of medical device (wound dressing).

Specifically, the document states:

  • "Data/information supporting the safety of DuoDERM CGF Control Gel Formula Border Dressing was presented in Premarket Notifications K901155. All testing was performed in accordance with Good Laboratory Practice Regulations." - This refers to safety testing, not a performance study against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI algorithm would be evaluated.
  • The 510(k) summary emphasizes substantial equivalence to a predicate device (SignaDRESS Hydrocolloid Dressing) based on intended use and dressing characteristics, rather than a quantifiable performance study with acceptance criteria.

Without a detailed performance study described in the provided text, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert adjudication, or MRMC studies.

N/A