Mini and Micro Fragments Reconstruction System – NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Device Description

Mini and Micro Fragments Reconstruction System – NEOFACE is a fixation system for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. It consists of implant plates and implant screws. The plates of the subject system include mini and micro fragment reconstruction plates. Plates are made of commercially pure titanium and screws are made of titanium alloy.

AI/ML Overview

The provided text describes a medical device, the "Mini and Micro Fragments Reconstruction System - NEOFACE," and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of an AI/algorithm-based system.

The document is a traditional 510(k) submission for a physical medical implant system (plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices through design principles, materials, technological characteristics, and mechanical testing.

Therefore, many of the requested bullet points, particularly those related to AI/algorithm performance (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance), cannot be extracted from this document as they are not applicable to the type of device described.

Here's what can be extracted based on the provided text, with explanations where information is missing or not applicable:

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

Acceptance Criteria	Reported Device Performance
Mechanical Strength (Plates): Satisfy ASTM F382 for bending strength.	Mechanical testing performed according to ASTM F382 to determine plate bending strength. (Specific quantitative results not provided in this summary.)
Mechanical Strength (Screws): Satisfy ASTM F543 for torsional strength, breaking angle, and axial pullout strength.	Screw torsional strength, breaking angle, and axial pullout strength determined according to ASTM F543. (Specific quantitative results not provided in this summary.)
Substantial Equivalence: Demonstrated to be substantially equivalent to predicate devices in intended use, operating principle, basic design, materials, packaging, and sterilization processes.	Confirmed by FDA ("We have reviewed... and have determined the device is substantially equivalent..."). The document lists multiple predicate devices and details similarities.

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

Not Applicable. This document describes mechanical testing of physical implants, not a "test set" in the context of an AI/algorithm. Mechanical testing generally involves predefined samples of the manufactured devices. The provenance of the testing (e.g., where the tests were conducted) is not specified beyond "NEOORTHO PRODUTOS ORTOPÉDICOS S/A" being located in Brazil.

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. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic algorithms. For mechanical testing, the "ground truth" is established by the standardized test methods (ASTM F382 and F543) and the physical properties of the materials and device design. The "experts" involved would be engineers or technicians performing the tests, but their specific number or qualifications are not detailed here, as it's typically understood to be standard practice for such testing.

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

Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessment. Mechanical testing relies on objective measurements according to standardized protocols, not adjudication.

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

No. An MRMC study is not mentioned as this is a physical medical device, not an AI or imaging diagnostic tool.

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

No. This is not an algorithm-based device.

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

The "ground truth" for this device revolves around the physical and mechanical properties of the materials and the manufactured implants, as evaluated against established ASTM standards (F382 for plate bending, F543 for screw torsional strength, breaking angle, and axial pullout strength).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/algorithm device.

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

Not Applicable. There is no "training set" and therefore no ground truth to be established for it.

Summary

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510(k) Summary

NEOORTHO PRODUTOS ORTOPÉDICOS S/A

2010

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM - NEOFACE

October 19, 2010

ADMINISTRATIVE INFORMATION

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Manufacturer Name:	NEOORTHO Produtos Ortopédicos S/ARua Ângelo Domingos Durigan, 607, CascatinhaCuritiba - PR 82020-340, Brazil
	Telephone:	+55 41 3535-1033
	Fax:	+55 41 3535-1018
Official Contact:	Luciane Yumi Suzuki de OliveiraNEOORTHO Produtos Ortopédicos S/A
Representative/Consultant:	Linda K. Schulz, BSDH, RDHKevin A. Thomas, PhDPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130 USA
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	lschulz@paxmed.com kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Mini and Micro Fragments Reconstruction System –NEOFACE
Common Name:	Bone plate, Intraosseous bone screw
Classification Regulations:	21 CFR 872.4760, 21 CFR 872.4880Class II
Product Code:	JEY, DZL
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

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INTENDED USE

Mini and Micro Fragments Reconstruction System - NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

NEOORTHO Produtos Ortopédicos S/A demonstrated that, for the purposes of FDA's regulation of medical devices, Mini and Micro Fragments Reconstruction System - NEOFACE is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Synthes (USA) Craniofacial Plate and Screw System cleared under K050608,

Synthes Orbital Plates cleared under K080331,

Synthes MatrixORTHOGNATHIC Plating System cleared under K083388,

Synthes MatrixMANDIBLE Preformed Reconstruction Plates cleared under K091144,

Biomet Mandibular Fracture / Reconstruction Devices (TraumaOne) cleared under K081067,

Walter Lorenz Surgical Mandibular Fracture / Reconstruction Devices and Pre-bent Plates cleared under K063052, and

Lorenz Sterile Bone Plates and Bone Screws cleared under K972322.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium or titanium alloys. The subject and predicate plates encompass the same range of physical dimensions, including length, thickness and shape. The subject and predicate plate designs include a variety of straight and geometric configurations that are commonly used in maxillofacial trauma and reconstructive surgery, in both locking and non-locking designs. The subject and predicate screws encompass the same range of physical dimensions and include locking, non-locking, self-tapping, and self-drilling designs. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods.

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Mechanical testing was performed to determine plate bending strength according to ASTM F382. Screw torsional strength, breaking angle, and axial pullout strength were determined according to ASTM F543.

Overall, Mini and Micro Fragments Reconstruction System - NEOFACE has the following similarities to the predicate devices:

. has the same intended use,
. uses the same operating principle,
. incorporates the same basic design,
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same processes. .

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NEOORTHO Produtos Ortopedicos S/A C/O Ms. Linda K. Schulz Paxmed International. LLC 11234 El Camino Real. Suite 200 San Diego, California 92130

DEC 2 0 2010

Re: K102641

Trade/Device Name: Mini and Micro Fragments Reconstruction System -NEOFACE Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: October 19, 2010 Received: October 20, 2010

Dear Ms. Schulz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Schulz

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h. for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Mini and Micro Fragments Reconstruction System – NEOFACE

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DEC 2 0 2010

510(k) Number: K102641

Mini and Micro Fragments Reconstruction System - NEOF ACE Device Name:

Indications for Use:

Prescription Use _X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K102641
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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.