SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM by SYNTHES (USA)

The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

Device Description

The Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium.

AI/ML Overview

The provided document is a 510(k) summary for the Synthes MatrixMANDIBLE Plate and Screw System. It is a regulatory submission for a medical device and therefore describes the device's technical specifications and intended use, but not a detailed study proving its performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, rather than providing raw performance data from a specific study. Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not describe specific acceptance criteria or performance metrics for a study demonstrating the device's efficacy or safety directly. It establishes substantial equivalence to existing devices. In general, for devices like these, performance is demonstrated through mechanical testing (e.g., fatigue, pull-out strength), biocompatibility testing, and often comparison to predicate device performance specifications, but these details are not included here.
Device Description: The device is a plate and screw system made of titanium, designed in various shapes and thicknesses, accepting self-tapping and self-drilling screws.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. This is not a study report with test sets or data provenance in that sense. Substantial equivalence is often based on design comparisons, material specifications, and performance data from internal engineering tests rather than patient-based test sets.

3. 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. This question pertains to studies involving expert review for tasks like image interpretation, which is not relevant for this type of medical device submission. Ground truth, in this context, would relate to engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Similar to point 3, this refers to expert adjudication in studies, which is not part of this 510(k) submission.

5. 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 question describes an AI-related study design. The Synthes MatrixMANDIBLE Plate and Screw System is a physical surgical implant, not an AI or imaging device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As above, this is for AI/algorithm-based devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be directly stated from the document. For a device like this, ground truth would typically relate to established biomechanical properties, material standards (e.g., ASTM, ISO for titanium implants), and successful long-term use of similar predicate devices in clinical practice. The "ground truth" for this submission is that it is substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

Applicable only if considering the "training" of the design process based on predicate devices. This document does not detail a "training set" in a data science context. The design of the device is likely informed by the specifications and successful history of the predicate devices.

9. How the ground truth for the training set was established

Not applicable in the data science sense. The "ground truth" for the predicate devices would be their long-standing clinical use and compliance with regulatory standards.

Summary of what can be extracted from the document:

Device Name: Synthes MatrixMANDIBLE Plate and Screw System
Intended Use: Oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).
Classification: Class II per 21 CFR §872.4880: Screw, Fixation, Intraosseous; and also 872.4760: Bone Plate.
Predicate Devices: Synthes MatrixMANDIBLE Plate and Screw System (implies an updated version of an existing device or a new product line within the same family), Synthes SMF Self-Drilling Screws.
Basis for Acceptance: The FDA determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and safety/effectiveness profiles to devices already on the market.

Summary

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Ko 82 3 35

3.0	510(k) Summary	Page 1 of 1
	Sponsor:	Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6604
	Contact:	Amnon TalmorSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6604NOV 10 2008
	Device Name:	Synthes MatrixMANDIBLE Plate and Screw System
	Classification:	Class II per 21 CFR §872.4880: Screw, Fixation, Intraosseous
	Predicate Devices:	Synthes MatrixMANDIBLE Plate and Screw SystemSynthes SMF Self-Drilling Screws
	Device Description:	The Synthes MatrixMANDIBLE Plate and Screw Systemincorporates small, medium and large plates designed so allplates accept all system screws. The plates are available invarious shapes and thicknesses and accept self-tapping andself-drilling cortex and locking screws. The implants aremanufactured from titanium.
	Intended Use:	The Synthes MatrixMANDIBLE Plate and Screw System isintended for oral, maxillofacial surgery; trauma; reconstructivesurgery; and orthognathic surgery (surgical correction ofdentofacial deformities).
	Substantial Equivalence:	Information presented supports substantial equivalence.

and the comments of the comments of

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Amnon Talmor Regulatory Affairs Specialist Synthes (USA) 1301 Goshen Parkway West Chester, Pennsylvania 19380

NOV 1 0 2008

Re: K082335

Trade/Device Name: Synthes MatrixMANDIBLE Plate and Screw System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 13, 2008 Received: August 14, 2008

Dear Mr. Talmor:

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.

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Page 2 -- Mr. Talmor

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 (OS) regulation (21 CFR Part 820): and if applicable, the clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Super Linnes

Chiu S. Lin, Ph. D.

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

Enclosure

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2.0

KO22335 510(k) Number (if known): Device Name: Synthes MatrixMANDIBLE Plate and Screw System Indications for Use: The Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

Indications for Use

Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suriano

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K082338

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.