The provided document is a 510(k) summary for the Aesculap Absorbable CranioFix, a medical device for cranial bone flap fixation. This document is a regulatory submission, not a study report, and therefore does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical or technical study.

Here's a breakdown of why the requested information is not present in this document:

Acceptance Criteria and Reported Device Performance (Table): This type of information is typically found in a detailed performance study report. The 510(k) summary declares the device's intended use and describes its components, but it doesn't provide quantifiable performance metrics or pre-defined acceptance criteria that would be used in a study to "prove" the device meets them.
Sample size, data provenance (test set): Not applicable as no performance study is detailed.
Number of experts and qualifications, adjudication method (test set): Not applicable as no performance study with expert review is detailed.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable as no such study is mentioned or summarized.
Standalone (algorithm only) performance study: Not applicable as this is a medical device, not an AI algorithm.
Type of ground truth used: Not applicable as no performance study is detailed.
Sample size for the training set: Not applicable as this is a medical device, not an AI algorithm.
How the ground truth for the training set was established: Not applicable as this is a medical device, not an AI algorithm.

What the document does provide is:

Intended Use: Fixation of cranial bone flaps.
Device Description: Two absorbable discs connected by a suture loop.
Substantial Equivalence: The primary method for clearance, indicating the device is equivalent to existing, legally marketed devices (Synthes Resorbable Cranial Clamp, MacroPore CraniLoc NS). This means the device relies on the established safety and effectiveness of its predicates rather than new, independent performance studies against specific acceptance criteria.
Regulatory Information: Product code, regulation number, device class, and review panel.

To find the kind of information requested, one would typically need to refer to detailed design control documents, validation reports, or clinical trial summaries, which are usually not included in the public 510(k) summary but are part of the full 510(k) submission reviewed by the FDA.

Summary

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MAR 3 1 2004

K040080 Paige
Absorbable CranioFix

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Matthew M. Hull, Regulatory Affairs Manager800-258-1946 (phone)610-791-6882 (fax)matt.hull@aesculap.com (email)
TRADE NAME:	Aesculap Absorbable CranioFix
COMMON NAME:	Cranioplasty plate fastener
DEVICE CLASS:	CLASS II
PRODUCT CODE:REGULATION:	HBW882 5360

REVIEW PANEL: Neurology

INTENDED USE

Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.

DEVICE DESCRIPTION

Aesculap's Absorbable CranioFix consists of two absorbable discs connected by a suture loop.

PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for the Aesculap Absorbable CranioFix.

PERFORMANCE STANDARDS

No performance standards have been promulgated under Section 514 of the Food, Druq and Cosmetic Act for these devices.

SUBSTANTIAL EQUIVALENCE

The Aesculap Absorbable CranioFix as described in this premarket notification is substantially equivalent to these predicate devices:

Synthes Resorbable Cranial Clamp (modified) (K031654) .
Synthes Resorbable Cranial Clamp (K021408 and K031654) .
MacroPore CraniLoc NS (K002334) ◆

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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 eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2004

Mr. Matthew M. Hull Regulatory Affairs Manager Aesculap. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K040080

Trade/Device Name: Aesculap Absorbable CranioFix Regulation Number: 21 CFR 882.5250 Regulation Name: Burr hole cover Regulatory Class: II Product Code: GXR Dated: January 14, 2004 Received: January 15, 2004

Dear Mr. Hull:

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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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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

b. Mark N. Mellman

Celia M. Witten, Ph.D., M.D. 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 STATEMENT

510(k) Number (if known):

K040080

Device Name: Absorbable CranioFix

Indication for Use:

Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.

Prescription Use

Over-the-Counter Use

(per 21 CFR 801.109)

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

Mule N Milken

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

(Optional Format 3-10-98)

510(k) Number K040080

Regulation Number and Section

§ 882.5250 Burr hole cover.

(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).