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K Number
K033523
Device Name
COLLAGEN-ORC ANTIMICROBIAL MATRIX
Manufacturer
JOHNSON & JOHNSON MEDICAL, LTD.
Date Cleared
2004-10-21

(349 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K014129,K013814
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Collagen-ORC Antimicrobial Matrix is intended for the management of exuding wounds.

Under the supervision of a health care professional, Collagen-ORC Antimicrobial Matrix may be used for the management of:

  • Diabetic ulcers
  • Venous ulcers
  • Pressure ulcers
  • Ulcers caused by mixed vascular etiologies
  • Full-thickness & partial thickness wounds
  • Donor sites and other bleeding surface wounds
  • Abrasions
  • Traumatic wounds healing by secondary intention
  • Dehisced surgical wounds

Collagen-ORC Antimicrobial Matrix may be used under compression therapy with healthcare professional supervision.

Device Description

Collagen-ORC Antimicrobial Matrix is a sterile primary dressing comprised of freeze-dried composite of 55 % collagen, 44 % ORC, 1 % silver-ORC. Silver-ORC contains 25 % w/w ionically bound silver.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria for the "Collagen-ORC Antimicrobial Matrix."

The document is a 510(k) summary for a medical device submitted to the FDA. It details the device name, submitter's information, classification, description, and indications for use. It also states that biocompatibility studies were conducted, demonstrating the device to be "non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." However, it does not provide specific acceptance criteria for these biocompatibility studies, nor does it present a detailed study comparing the device's performance against any set criteria.

The 510(k) process primarily determines substantial equivalence to a predicate device, rather than requiring extensive clinical trials with predefined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) application would.

Therefore, I cannot extract the requested information regarding:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method
  5. Multi-reader multi-case (MRMC) comparative effectiveness study
  6. Standalone (algorithm only) performance
  7. Type of ground truth used
  8. Sample size for the training set
  9. How the ground truth for the training set was established

N/A