The Synthes Cranial Plates are intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive surgery of the midface and cranium; and orthognathic surgery of the maxilla and chin.

Device Description

The Synthes Cranial Plates are titanium plates in a variety of shapes and sizes for various cranio-facial procedures.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device rather than a study report for an AI/ML medical device. Therefore, the requested information about acceptance criteria, study design elements, and performance metrics for an AI device is not available in these documents.

Here's why and what can be extracted:

Why the requested AI/ML specific information is not available:

Device Type: The device described is "Synthes Cranial Plates," which are physical titanium plates used in craniofacial surgery. This is a traditional medical device, not an AI/ML software device.
510(k) Context: A 510(k) submission is primarily to demonstrate substantial equivalence to a legally marketed predicate device. For traditional devices like these plates, this typically involves material testing, mechanical strength, biocompatibility, and clinical experience with equivalent devices, rather than performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/ML diagnostic or prognostic tool.
Date: The approval date is February 20, 2002. AI/ML medical devices were not a prevalent category in medical device regulation at that time.

What can be extracted from the provided documents:

The documents are a "Summary of Safety and Effectiveness Information" and the FDA's clearance letter for the Synthes Cranial Plates.

A table of acceptance criteria and the reported device performance:
- Not applicable in the AI/ML context. For these cranial plates, the "acceptance criteria" were likely related to material properties (titanium), mechanical strength, biocompatibility, and sterilization, demonstrating equivalence to already marketed devices. These specific criteria and their performance results are not detailed in the publicly available summary provided. The summary states: "Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices." This implies that the device met the necessary performance and safety standards by being substantially equivalent to existing devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of an AI/ML study for this physical device. Testing would involve engineering and biocompatibility studies, not data-driven performance.
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 applicable. No expert ground truth establishment for a "test set" in the AI/ML sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 applicable. This device is a physical implant, not an AI assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable.
The sample size for the training set:
- Not applicable.
How the ground truth for the training set was established:
- Not applicable.

Summary of available information (re-contextualized for a traditional device):

Device Name: Synthes Cranial Plates
Manufacturer: Synthes (USA)
Classification: Class II, per §872.4760 (Plate, Fixation, Bone) and §882.5250 (Burr Hole Cover).
Indications for Use: Selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive surgery; orthognathic surgery of the maxilla and chin.
Material: Titanium
Basis for Clearance: Substantial equivalence to other legally marketed devices. The detailed evidence for this (e.g., specific tensile strength tests, fatigue tests, biocompatibility reports) would be in the full 510(k) submission, not typically in the public summary. The summary simply states "Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices," indicating that all necessary performance criteria for equivalence were met.

To reiterate, this document describes a conventional medical device (cranial plates) cleared in 2002, not an AI/ML medical device. Therefore, the questions specifically tailored to AI/ML device performance studies cannot be answered from this input.

Summary

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FEB 2 0 2002

Summary of Safety and Effectiveness Information 3.

Ko20087

Sponsor

Company Contact

Name of the Device

Device Classification(s)

Substantial Equivalence

Device Description

Indications

Material

Synthes (USA) 1690 Russell Road Paoli, PA 19301

Matthew M. Hull (610) 647-9700 ext. 7191

Synthes Cranial Plates

Class II, §872.4760 - Plate, Fixation, Bone Class II, §882.5250 - Burr Hole Cover

Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices.

The Synthes Cranial Plates are titanium plates in a variety of shapes The Synanes Crand for various cranio-facial procedures.

The Synthes Cranial Plates are intended for use in selective trauma of The ByInthos Craniofacial skeleton; craniofacial surgery; the initiface and craineral in is selective orthognathic surgery of the maxilla and chin

Titanium

Synthes(USA) Synthes Cranial Plates 510(k) CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2002

Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K020087

Trade/Device Name: Synthes Cranial Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: JEY and GXR Dated: January 07, 2002 Received: January 10, 2002

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Secuon 710(x) personalially equivalent (for the referenced above and have attermined to legally marketed predicate devices marketed in
indications for use stated in the enclosure , to legally marketed in
the enclose for us indications for use stated in the cholosator , to he enactment date of the Medical Device interstate commerce prior to reay 20, 1770, and enified in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approvel of a Amendments, or to devices that nave been rocal require approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires, subject to the general the Federal Food, Drug, and Cosment / col (recore, market the device, subject to the general
approval application (PMA). You may, therefore, market the Act include approval application (1 MA). "Tou may) and controls provisions of the Act include controls provisions or the Act. The genting of devices, good manufacturing practice, requirements for annical rogginst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) incolors. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Time 21, Rests 800 to 898 (PMA), it may be subject to Such additional concern Regulations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Register i your device can be found in the Code of Pecelar regionerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualles of a substance of the requirements
mean that FDA has made a determination that your device complies with organizes mean that FDA has made a decemination untily of the Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Matthew M. Hull

You must comply with all the Act's requirements, including, but not limited to: registration
ing and the many of the line (0) - GED Port Roll); good manufacturing practice You must comply with all the Act s'requirence.se increating oud manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labellity (21 CF PC PC PC Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QB) regulation (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 This letter will allow you to begin marketing your covistantial equivalence of your device to
510(k) premarket notification. The FDA finding of sourcevice and thus, 510(k) premarket notification. The PDA finantig or casestion for your device and thus, a legally mur device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801
) and the If you desire specific advice for your device in vitro diagnostic devices), please contact the and additionally 21 CFR Part 809.10 for in valid the donestions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Compliance at (301) 594-4015. "Italifone of Compliance at (301) 594-4639.
advertising of your device, please contact the Office has been programs to premarket advertising of your device, picase consisted, "Misbranding by reference to premarket. Also, please note the regulation entitled, "Internation on your responsibilities under
notification" (21CFR Part 807.97). Other general information on your responsibilities notification" (21CFR Part 807.97). Unier general Manufacturers, International and the Act may be obtained from the Division of Only 638-2041 or (301) 443-6597 or at its
Consumer Assistance at its toll-free number (80) was an html Consumer Assistance at its ton nov fodrh/dsma/dsmamain.html

Sincerely yours,

Patrea Cinciniffe

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 2.

510(k) Number (if known):

Device Name:

Indications for Use:

Synthes Cranial Plates

The Synthes Cranial Plates are intended for use in I he Synthes Crainal I lawdface and craniofacial is selective trauma of the mirala"; reconstructive skeleton; cramoracial surgery, orthognathic surgery of the maxilla and chin.

020087

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

CONFIDENTIAL

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

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Division Sign-Off	Phamida D. Sood for Swann H
	Dental Infection Control,
	ral Devices
	KC20087

Synthes(USA) Synthes Cranial Plates 510(k)

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.