The provided text does not contain information about acceptance criteria or a study proving that the Dura-Guard device meets acceptance criteria in the manner requested by the prompt. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance acceptance criteria and a study to meet them.

Specifically, the document states:

"Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles." This indicates that some testing was done and a comparison was made between treated and untreated samples of the device, but it does not specify quantitative acceptance criteria for these tests.
"Biocompatibility testing also showed no significant difference between the test and control articles." Again, testing was performed, but no acceptance criteria are provided.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies for a performance study.

Here's a summary of what is available regarding testing, and an explanation of why the requested information cannot be provided based on the input:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified (e.g., Specific burst strength in psi, specific tensile strength in N)	"No significant difference between the test and control articles" for burst strength, suture retention, ultimate tensile, and shrink temperature testing.
Not specified (e.g., Specific biocompatibility endpoints)	"No significant difference between the test and control articles" for biocompatibility testing.

Study Details (Information Not Available in the Provided Text)

Sample size used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device's "acceptance" is based on physical material properties and biocompatibility, not expert-adjudicated images or clinical outcomes in the way implied by "ground truth" for AI/human reader studies.
Adjudication method: Not applicable.
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: This device is a dural repair patch, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
The type of ground truth used: For material properties, the "ground truth" is measured physical properties. For biocompatibility, it's the results of standard biological tests. There's no "expert consensus" or "pathology" in the context of device performance in the way described for AI/diagnostic studies.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating that the device (Dura-Guard subjected to antibiotics) is substantially equivalent to an existing predicate device (Dura-Guard not subjected to antibiotics) by showing "no significant difference" in critical performance characteristics. It doesn't detail performance against specific, predefined acceptance thresholds which is often found in performance studies for novel devices or software.

Summary

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5973706

Bio-Vascular, Inc.

DEC 2 4 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name & Address:	Bio-Vascular, Inc., 2575 University Ave., St. Paul,MN 55114-1024
Contact:	Barbara Atzenhoefer, Regulatory Affairs Manager
Date Prepared:	September 26, 1997
Common or Usual Name:	Dura-Guard®
Device Classification Name:	Dural Repair Patch
Substantial Equivilance:	Dura-Guard K950956

Dura-Guard is a dural repair patch manufactured from bovine Device Description: pericardium cross-linked with glutaraldehyde.

Statement of Intended Use:

For use as a dural substitute for the closure of dura mater during neurosurgery.

Summary/Comparison of Technological Characteristics:

Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles. Biocompatibility testing also showed no significant difference between the test and control articles. BVI believes that product subjected to antibiotics perform in a manner substantially equivalent to product not subjected to antibiotics, and that the exposure to antibiotics poses no additional questions of safety or effectiveness.

F:\DATA\WP\REGAFF\SUBMISON\USA\DG\ANTIBIO.1

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 1997

Ms. Barbara Atzenhoefer Regulatory Affairs Manager Bio-Vascular, Inc. 2575 University Avenue Saint Paul, Minnesota 55114-1024

Re: K973706

Trade Name: Dura-Guard - Dura Repair Patch Regulatory Class: II Product Code: GXO Dated: September 26, 1997 Received: September 29, 1997

Dear Ms. Atzenhoefer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Barbara Atzenhoefer

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Willy Wold

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K97 3 J O _ 6

Device Name: Dura-Guard - Dural Repair Patch

Indications for Use:

For use as a dural substitute for the closure of dura mater during neurosurgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X Per 21 CFR 801.109

Over-The-Counter Use

Ulan will

(Division Sign-Off) Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).