The Aesculap Craniofacial Plate and Screw System is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Description

The Aesculap Craniofacial Plate and Screw System consists of various sizes and shapes of plates and several lengths of 1.5mm screws (to include 1.8mm emergency screws). The screws are manufactured from Titanium forged alloy Ti6Al4V and the plates from CP Titanium (Ti Grade 2).

AI/ML Overview

The provided document, K060492, is a 510(k) summary for the "Aesculap Craniofacial Plate & Screw System." This document describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not present a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study.

Instead, the "Performance Data" section briefly mentions mechanical testing. Therefore, I cannot fulfill the request as it pertains to AI/human reader performance, sample sizes for training/test sets, expert adjudication, or MRMC studies.

However, I can extract the information related to the mechanical performance testing that was conducted.

Here's the information based on the provided document, addressing the relevant sections:

Acceptance Criteria and Device Performance (Mechanical Testing)

Test Type	Acceptance Criteria (from ASTM Standard)	Reported Device Performance
Screws: Pull-out	Performed per ASTM F543	Not explicitly stated in the document, but implicitly met for 510(k) clearance
Screws: Torque	Performed per ASTM F543	Not explicitly stated in the document, but implicitly met for 510(k) clearance
Plates: Bending	Performed per ASTM F382	Not explicitly stated in the document, but implicitly met for 510(k) clearance

Note: The document states that the tests were performed "per ASTM F543 for pull-out and torque" and "per ASTM F382 for bending." This indicates that the device's performance was evaluated against the standards outlined in these ASTM specifications. For a 510(k) clearance, the implied acceptance criterion is that the device met the relevant performance requirements of these standards to be considered substantially equivalent. The specific quantitative results of these tests and the exact acceptance thresholds are not detailed in this summary.

Regarding the AI/human reader specific questions, the document does not contain this information:

Sample sizes used for the test set and the data provenance: Not applicable, as this is not an AI/human reader study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this was not done. This document describes a medical device (craniofacial plates and screws), not an AI algorithm for diagnostic imaging.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" would be the specified physical properties and performance metrics defined within the ASTM standards.
The sample size for the training set: Not applicable, as there is no training set for mechanical testing of this type of device.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

K060492

Page 1 of 2

7 2006 APR

510(k) SUMMARY (as required by 21 CFR 807.92) B.

Craniofacial Plate & Screw System 23 February 2006

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Vallev. PA 18034 Establishment Registration Number: 2916714

CONTACT: Matthew M. Hull 800-258-1946 (phone) 610-791-6882 (fax) matt.hull@aesculap.com (email)

TRADE NAME: Aesculap Craniofacial Plate & Screw System

COMMON NAME: Craniofacial plates and screws

CLASSIFICATION NAMES: Bone plate/ Intraosseous fixation screw/ Burr hole cover/ Preformed nonalterable cranioplasty plate

REGULATION NUMBERS: 872.4760/ 872.4880/ 882.5250/ 882.5330

PRODUCT CODES: JEY/ DZL/ GXR/ GXR/ GXN

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the additional plates and screws are described here are substantially equivalent to the craniofacial plates and screws previously cleared in the Aesculap Premarket Notification #K923705.

DEVICE DESCRIPTION

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The new components of the Craniofacial Plate & Screw System are offered in similar in shapes and sizes as the predicate devices. The plates are manufactured from CP Titanium which is the same material as the predicate devices, the new screws will be made of a Titanium Alloy.

{1}------------------------------------------------

Page 2 of 2

PERFORMANCE DATA

The screws were tested per ASTM F543 for pull-out and torque while the plates were tested per ASTM F382 for bending.

・・・ 11 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's symbol, which is a stylized representation of a human figure embracing another. The symbol is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" in a circular arrangement.

7 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060492

Trade/Device Name: Aesculap Craniofacial Plate and Screw System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 23, 2006 Received: March 1, 2006

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.

{3}------------------------------------------------

Page 2 – Mr. Hull

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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Snette Y. Michael Dm.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

A. INDICATIONS FOR USE STATEMENT

510(k) Number: K060492

Device Name: Aesculap Craniofacial Plate and Screw System

Indications for Use:

Prescription Use _ and/or Over-the-Counter Use (Part 21 CFR 801 Subpart D) (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)

Susan Roane

ിന്നും General Hospital

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.