UNI-GRAFT K DV PATCH by ATRIUM MEDICAL CORP.

This is an FDA 510(k) clearance letter for the B.Braun Surgical GMBH Uni-Graft® KDV Patch. The letter itself does not contain the detailed study information, acceptance criteria, or performance data you are requesting. It only states that the device is substantially equivalent to legally marketed predicate devices.

To answer your questions, you would need to refer to the original 510(k) submission (K992776) made by Atrium Medical Corporation to the FDA. This submission would contain the details of any studies performed to demonstrate substantial equivalence, including:

A table of acceptance criteria and the reported device performance: This would be found in the performance testing section of the 510(k) submission, comparing the new device against the predicate device or a set of defined performance specifications.
Sample size used for the test set and the data provenance: Details on test articles, their quantity, and the conditions under which they were tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Less likely to be relevant for a medical device like a vascular patch, where "ground truth" might refer to engineering specifications or material properties rather than clinical expert consensus. This kind of detail is more common for diagnostic algorithms.
Adjudication method for the test set: Again, less likely to be relevant for this type of device.
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 is entirely irrelevant for a vascular patch. MRMC studies are for diagnostic imaging devices or AI-powered assistive technologies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Also irrelevant, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a vascular patch, ground truth would likely relate to material properties (e.g., tensile strength, porosity, biocompatibility), performance in in-vitro or in-vivo models (e.g., burst pressure, suture retention), and potentially animal or limited human clinical data demonstrating safety and efficacy comparable to a predicate.
The sample size for the training set: Irrelevant, as this is a physical device, not a machine learning model.
How the ground truth for the training set was established: Irrelevant.

In summary, this document (the 510(k) clearance letter) does not contain the information you are requesting. You would need to access the full 510(k) submission K992776, which is typically a much larger document outlining the device description, comparison to predicate devices, and performance data from engineering tests, biocompatibility studies, and potentially other non-clinical or clinical data as required for substantial equivalence. These submissions are generally not publicly available in their entirety in an easily searchable format, though summaries might be found on the FDA website.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Mr. Joseph P. De Paolo Director of Regulatory Affairs Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051

Re : K992776 K992770
Trade Name: B.Braun Surgical GMBH Uni-Graft® KDV Patch Requlatory Class: II Product Code: DXZ Dated: August 13, 1999 Received: August 18, 1999

Dear Mr. De Paolo:

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 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). 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 Title 21, Parts 800 to 895. A substantially Requlations, equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) 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 obliqation 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 - Mr. Joseph P. De Paolo

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

a é écripe le le le le le le le le le le le le le le le le le le le le la le la le la le la le la le la le la contra le la contra le la contra le la contra le la contra le la in chic. 1000 Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Device and Radioloqical Health

Enclosure

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Page 1 of 1 510(k) Number (if known): K 992776 Device Name: Uni-Graft® K DV Patch Indications for Use:

A vascular patch used for reconstructive interventions in the region of the carotid artery, profunda, femoral, arteria iliaca.

& prescription

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loree K. Sampeur

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

1690:27760 510(k) Number _

Atrium Medical Corporation

CONFIDENTIAL

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).