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K Number
K030921
Device Name
COLLAGEN TOPICAL WOUND DRESSING
Manufacturer
COLLAGEN MATRIX, INC.
Date Cleared
2003-05-15

(52 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K910944,K012990,K990086,K955506,K925548
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:

  • Pressure ulccrs
  • . V cnous stasis ulcers
  • Diabetic ulcers .
  • Acute wounds, for cxample trauma and surgical wounds ●
  • Partial-thickness burns
Device Description

The Collagen Topical Wound Dressing is a white to off-white, absorbent, microfibrillar particulate collagen matrix intended for topical use. The product is supplied sterile and for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Collagen Topical Wound Dressing." It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on "similar technological characteristics" and safety/biocompatibility testing. It states:

  • "The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate devices."
  • "The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices."

Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance from this document. The document confirms the device passed biocompatibility tests per ISO 10993-1, but doesn't specify quantitative "performance" criteria beyond "safe and substantially equivalent" for its intended use of managing exudating wounds and controlling minor bleeding.

Here's why the other requested information cannot be extracted from this document:

  1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on biocompatibility and substantial equivalence, not measurable performance against specific criteria for wound management efficacy.
  2. Sample size used for the test set and the data provenance: Not present. The document only mentions "in vitro product characterization studies and biocompatibility studies" without details on sample sizes or data origin. This likely refers to lab-based tests, not clinical studies.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. "Ground truth" is typically associated with diagnostic or classification performance, which isn't the focus here. The "test set" described are likely laboratory samples for biocompatibility and characterization.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not present.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a topical wound dressing, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of device performance. For biocompatibility, the "ground truth" would be the established ISO 10993-1 standards for biological response.
  8. The sample size for the training set: Not applicable. This document describes material characterization and biocompatibility testing, not a machine learning model.
  9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) summary demonstrates substantial equivalence through material characterization and biocompatibility testing, but it does not provide the kind of performance data (acceptance criteria, clinical study results, expert evaluations, etc.) that would be associated with a device needing such specific "acceptance criteria" for efficacy beyond safety and general function, particularly in the context of diagnostic or interpretive devices.

N/A