Search Results

CollaGUARD may be used for the management of wounds such as:

• Pressure ulcers .
• . Venous stasis ulcers
• . Diabetic ulcers
• First and second degree burns .
• Partial and full thickness wounds .
• Superficial injuries .

CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.

The provided text is a 510(k) Summary for a medical device called CollaGUARD. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a performance study with acceptance criteria in the way a typical clinical trial or algorithm validation study would.

Therefore, the requested information elements related to specific acceptance criteria, device performance metrics, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's an explanation based on the provided text, highlighting what is and isn't available:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in this context. This document is a 510(k) summary demonstrating substantial equivalence, not a report of a performance study with specific acceptance criteria and outcome metrics. The "performance" being demonstrated here is primarily that the device is "substantially equivalent" to a predicate, not that it meets specific numeric clinical efficacy targets.
• The document implies that the device performs equivalently to its predicate by stating: "CollaGUARD™ is substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc." and "The collagen products have an extensive and established history of safety and effectiveness."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. No specific "test set" in the context of a performance study (e.g., patient data for algorithm validation) is mentioned. The submission relies on existing knowledge and biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. Ground truth establishment by experts for a test set is not part of this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No adjudication method is described for a test set.

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 / Not Provided. This device is a topical wound dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable / Not Provided. This is a physical medical device (wound dressing), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided for a "study ground truth." The "ground truth" for this 510(k) submission is the regulatory precedent set by the predicate device (K040558) and the established safety and effectiveness of collagen products, supported by biocompatibility testing against ISO standards.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided.

Summary of what the document does state regarding acceptance and evidence:

• Device Name: CollaGUARD™
• Intended Use: Management of wounds such as Pressure ulcers, Venous stasis ulcers, Diabetic ulcers, First and second-degree burns, Partial and full-thickness wounds, Superficial injuries.
• Acceptance Criteria (Implied by 510(k) Process): The core acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety and effectiveness.
• Study Proving Acceptance (Evidence Provided):
  • Biocompatibility Testing: CollaGUARD's biocompatibility testing was completed against the requirements of ISO 10993 -1:2003. The device "passed the requirements of all tests and has been shown to be a biocompatible topical wound dressing." This is a specific study mentioned.
  • Comparison to Predicate Device: CollaGUARD™ is stated to be "substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc."
  • Historical Data: "The collagen products have an extensive and established history of safety and effectiveness." This refers to a long-standing understanding of collagen's role in wound healing, not a specific new study for CollaGUARD.
• Conclusion: Based on the substantial equivalence to the predicate device and satisfactory biocompatibility testing, the FDA determined that the device could be marketed.

Ask a specific question about this device