Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Device Description

The CranioFix and CranioFix2 Clamp System consist of sterile, titanium implants (Clamps) and associated manual instruments. The Clamps are available in three sizes: 11mm, 16mm, and 20mm. The clamp consists of two concave disks which are connected with a pin through the center. The pin is securely attached to the lower disk; the upper disk is loosely mounted onto the pin. Each disk has rows of teeth extending along the edge of the concave side. The disks are mounted onto the pin with the teeth of each one facing the teeth of the other. The disks of the CranioFix Titanium Clamp (11mm) are solid (no drainage holes). The disks of the CranioFix Titanium Clamp (16mm and 20mm) have open areas for drainage. The CranioFix2 Titanium Clamp (11mm, 16mm, and 20mm) have a sleeve securely attached on the end of the pin. During the fixation, the lower disk comes to rest against the inner surface of the cranium and the upper disk comes to rest against the outer surface of the cranium.

AI/ML Overview

Here's an analysis of the provided text regarding the CranioFix Titanium Clamp System, focusing on the acceptance criteria and study information:

Based on the provided document, there is no performance data or studies presented for acceptance criteria. The document is a 510(k) summary for marketing clearance and primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting new performance study data against defined acceptance criteria.

Here's a breakdown of why and what information is present:

A table of acceptance criteria and the reported device performance
- Not present. The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This indicates that there are no pre-defined performance metrics or acceptance criteria presented in this submission. The basis for clearance is "substantial equivalence" to previously cleared devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No specific performance study with a test set is mentioned.
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 present. No ground truth establishment related to a device performance study is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No adjudication method is mentioned as there's no performance study described.
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 present. This device is a titanium clamp system, not an AI or imaging device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not present. No ground truth relevant to device performance is mentioned.
The sample size for the training set
- Not present. No training set is mentioned as there's no performance study described.
How the ground truth for the training set was established
- Not present. No ground truth for a training set is mentioned.

Summary of available information from the document:

Intended Use: Fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
Device Description: Sterile, titanium implants (Clamps) in 11mm, 16mm, and 20mm sizes, consisting of two concave disks connected by a pin. Design variations between CranioFix and CranioFix2 are described.
Purpose for Submission: To gain marketing clearance for additions to the Clamp System and expansion of the indication for use statement.
Performance Data: "No performance standards have been promulgated."
Substantial Equivalence: Demonstrated to predicate devices:
- Aesculap CranioFix Titanium Clamp System (K972332)
- Aesculap Craniofacial Implant Set (K923705)

Conclusion:

The provided 510(k) summary for the CranioFix Titanium Clamp System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices, which is a common pathway for medical device clearance in the U.S. when a new device is similar enough to existing ones. This implies that the safety and effectiveness are established through the existing knowledge and clearance of the predicate devices.

Summary

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JUN 1 7 2004

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

K046864

craniofix titanium clamp system

April 1, 2004

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Kathy A. Racosky, Regulatory Affairs Associate800-258-1946 (phone)610-231-3713 (fax)kathy.racosky@aesculap.com (email)
TRADE NAME:	CranioFix and CranioFix2 Titanium Clamp System
COMMON NAME:	Cranioplasty Plate Fastener (Burr Hole Cover)
DEVICE CLASS:	CLASS II

PRODUCT CODE DEVICE		CLASSIFICATION	REVIEW PANEL
84HBW	Fastener, Plate,Cranioplasty	882.5360	84 Neurology
84GXR	Cover, Burr Hole	882.5250	84 Neurology
76JEY	Plate, Bone	872.4760	76 Dental
84GXN	Plate,Cranioplasty,Preformed, Non-Altered	882.5330	84 Neurology

INTENDED USE

Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

DEVICE DESCRIPTION

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K040864

PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for additions to rne purpose for this Clamp System and the expansion to the indication for use statement for Aesculap's Titanium CranioFix Clamp System.

PERFORMANCE DATA

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

SUBSTANTIAL EQUIVALENCE

The device modifications and expanded indications for use described in this premarket notification are substantially equivalent to these predicate devices:

Aesculap CranioFix Titanium Clamp System (K972332) .
Aesculap Craniofacial Implant Set (K923705) .

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with a flowing ribbon-like design below them. The image is in black and white.

Public Health Service

JUN 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K040864

Trade/Device Name: CranioFix Titanium Clamp System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: April 1, 2004 Received: April 2, 2004

Dear Ms. Racosky:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 75 ttg enactment date of the Medical Device Amendments, or to conninered prior to Milly 20, 178, in accordance with the provisions of the Federal Food, Drug, devices that have been receive approval of a premarket approval application (PMA). and Cosmetic rece (110) that to neview, subject to the general controls provisions of the Act. The r ou may, dierelere, mains of the Act include requirements for annual registration, listing of general controls pro reseries, 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 If your device is easonned (ional controls. Existing major regulations affecting your device can thay be subject to buen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ooncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTT of localites of our device complies with other requirements of the Act that 1 Dr has made a associations administered by other Federal agencies. You must or any I edetal states and states and states and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Far 607); lacemig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordinal are qualisy 351-542 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) This letter will anow you to begin manisang your and equivalence of your device to a legally premaired 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 If you desire specific acrice 101 ) 594-4659. Also, please note the regulation entitled, Connact the Orification of Company of Cet notification" (21CFR Part 807.97). You may obtain Misorallumg by reference to premainer stibilities under the Act from the Division of Small other general information on Jour response 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,

Marlie M Millenson

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):

040864

Device Name: CranioFix Titanium Clamp System

Indication for Use:

Aesculap's CranioFix and CranioFix2 System are intended for use in the fixation of Aesourap 3 - Oraniot xx and fixation of cranial fractures.

Prescription Use_X (per 21 CFR 801.109)

Over-the-Counter Use ________________________________________________________________________________________________________________________________________________________ or

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

l. Mark N. Milkeerson

Division of General, Restorative. and Neurological Devices

(Optional Format 3-10-98)

510(k) Number K040864

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).