The CRANIOFIX Titanium Clamp System consists of a sterile, titanium implant (CRANIOFIX Clamp) and associated nonpowered neurosurgical instruments. The CRANIOFIX Titanium Clamp (FF100T) consists of two 10mm 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. During the craniotomy refixation, the lower disk comes to rest against the inner surface of the cranium and the bone plug. The upper disk comes to rest against the outer portion of the cranium and bone plug.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Aesculap CRANIOFIX Titanium Clamp System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

Here's why the requested information cannot be fully provided based on the input:

No detailed performance data or acceptance criteria are present. The document focuses on technological characteristics, intended use, and substantial equivalence to market approval.
No clinical study summaries, sample sizes, or expert involvement are mentioned. The text only states that the device "will be manufactured in accordance with ISO and German Din Standards" and that Aesculap has "ISO 9001 certification," which are quality system certifications, not performance criteria for the device itself.
The document is a pre-market notification (510(k)) for substantial equivalence, not a clinical trial report. Substantial equivalence claims generally rely on comparisons to existing legally marketed devices, not necessarily on new, extensive performance studies with specific acceptance criteria outlined in the submission itself.

Therefore, for each of the requested points, the answer is that the information is not available in the provided 510(k) summary.

Detailed Breakdown of Missing Information:

A table of acceptance criteria and the reported device performance:
- Not available. The document states "No applicable performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices." It mentions manufacturing to ISO and German Din Standards, but these are quality system standards, not specific device performance acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. No test sets or study data are described in this 510(k) summary.
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 available. This information would be relevant to studies involving ground truth establishment, which are not detailed here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available. No test sets or adjudication methods are mentioned.
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 available. This device is a titanium clamp system, a physical medical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not available. This device is a physical implant, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not available. No studies requiring ground truth are described.
The sample size for the training set:
- Not available. No training sets are mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not available. Not applicable.

In summary, the provided 510(k) document is a declaration of substantial equivalence for a physical medical device (titanium clamp system) and does not include the detailed performance study information, acceptance criteria, or AI-related metrics that are being requested.

Summary

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Image /page/0/Picture/0 description: The image shows the word "AESCULAP" in bold, capital letters, with a medical symbol to the left of the word. Above the word is the number "K972332" in handwritten font. Below the word is the date "JAN 1 6 1998".

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Aesculap CRANIOFIX Titanium Clamp System

October 16, 1997

Submitted by:

Aesculap®, Inc. 100u Gatewav Divu. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (650) 876-7000 x348 FAX: (650) 589-3007

Aesculap CRANIOFIX Titanium Clamp System Product: Burr Hole Cover and Associated Common Names: Nonpowered neurosurgical instruments

Intended Use

Aesculap's CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.

Device Description

003

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Technological Characteristics

The CRANIOFIX Titanium Clamp presses the bone cover and the vault of the cranium between the two disks. The implant is fixed to the cranium by means of special CRANIOFIX nonpowered neurosurgical instrument. It shares similar technological characteristics with titanium mini-plates which are attached to the cranium with bone screws. The main difference between CRANIOFIX and the comparative devices is the means of application.

Performance Standards

No applicable performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. However, the CRANIOFIX Titanium Clamp System will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification.

Substantial Equivalence

Aesculap's CRANIOFIX Titanium Clamp System shares similar features and function with corresponding devices distributed by:

Aesculap ●
. KLS Martin
Leibinger .
Zimmer .

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 16 1998

Ms. Mary Ellen Holden ·Regulatory Compliance Associate Aesculap, Inc. 1000 Gateway Boulevard 94080-7030 South San Francisco, California

K972332 Re: Aesculap CranioFix Titanium Clamp System Regulatory Class: II Product Code: GXN Dated: October 16, 1997 October 20, 1997 Received:

Dear Ms. Holden:

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 The general controls provisions of the Act 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Mary Ellen Holden

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) 594-4659. 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,

ia 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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INDICATION FOR USE STATEMENT

510(k) Number (if known): K972332

Device Name:

Aesculap CRANIOFIX Titanium Clamp System. *

Indication for Use:

. .

Aesculap's CRANIOFIX Titanium Clamp System is intended for use in refixation of cranial bone flaps after craniotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K972332

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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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).