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.

Summary

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Image /page/0/Picture/1 description: The image shows the word "Innocoll" in a bold, sans-serif font. The word is underlined with a thick, black line. Below the line, the word "Pharmaceuticals" is written in a smaller, sans-serif font.

OCT - 2 2006

pass 1 g 2

IDA Business & Technology Park
Garrycaltie, Athlone
Co. Westmeath, Ireland
Tel: +353 (0)90 6486834
Fax: +353 (0)90 6486835
www.innocoll-pharma.com

510(k) Summary

1. Date Prepared: August 15, 2005

Submitter

Innocoll Pharmaceuticals IDA Business and Technology Park Garrycastle Athlone Co. Westmeath Ireland. Tel: +353 (0) 9064 86834 Fax: +353 (0) 9064 86835

Submission Correspondent: Aaron Wyse Director of Quality and Regulatory Affairs

CollaGUARD™ 3. Proprietary Name:
1. Common Name: Topical Wound Dressing
1. Device Classification: Product Code: KMF Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified

6. Statement of Substantial Equivalence:

CollaGUARD™ is substantially equivalent in materials of construction and intended use to Collagen Topical Wound Dressing (K040558) manufactured by Collagen Matrix Inc.

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K061746
Page 5 - 2

7. Intended Use

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

8. Description

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

9. Biocompatibility

CollaGUARD's biocompatibility testing has been completed against the requirements of ISO 10993 -1:2003. CollaGUARD has passed the requirements of all tests and has been shown to be a biocompatible topical wound dressing.

10.Conclusion

CollaGUARD™ is a member of a family of collagen products distributed by Innocoll Pharmaceuticals. The collagen products have an extensive and established history of safety and effectiveness. Collagen has a primary role in all phases of wound healing making it an effective agent for managing wound treatment.

CollaGUARD™ is substantially equivalent to the predicate device delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings, and a wavy line representing its legs. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innocoll Pharmaceuticals % Mr. Aaron Wyse Director of Quality and Regulatory Affairs IDA Business and Technology Park. Garrycastle, Athlone Co. Westmeath, Ireland

OCT - 2 2006

Re: K061746

Trade/Device Name: CollaGuard Regulation Name: Collagen Dressing Regulatory Class: Unclassified Product Code: KGN Dated: August 15, 2006 Received: August 31, 2006

Dear Mr. Wyse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Aaron Wyse

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours. Mark N. Melkerson Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: CollaGUARD

Indications For Use:

Indications:

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 .

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of General, Restorative,
	and Neurological Devices
510(k) Number	LC6-1746

Regulation Number and Section

N/A