Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

The Frontier Devices Mandible Reconstructive System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Mesh System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Description

Frontier Devices Maxillofacial System: implantable bone screws and plates for oral and maxillofacial procedures including fractures, orthognathic, reconstructive procedures and revisions procedures when other treatments of devices have failed. Plates are made from medical grade unalloyed titanium (commercially pure Titanium grade 4, ASTM F-67). Screws are made from alloyed titanium (Titanium 6Al 4V, ASTM F-136).

Frontier Devices Orthognathic System: titanium bone plates and screws of various shapes and sizes. Plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-tapping screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

Frontier Devices Mandible Reconstruction System: titanium bone plates and screws of various shapes and sizes intended for use for maxillofacial, orbital reconstruction and specialized orthognathic surgery. Plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-tapping screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

Frontier Devices Mesh System: titanium meshes and screws of various shapes and sizes. Meshes are made from unalloyed titanium that conforms to the ASTM F67 standard. Screws are self-drilling screws made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.

AI/ML Overview

The provided text focuses on the 510(k) premarket notification for several Frontier Devices systems, emphasizing their substantial equivalence to predicate devices. It describes the devices, their intended use, and technology characteristics, concluding that performance tests on representative screws showed similar results to predicate screws.

However, the document does not contain the detailed information requested regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's an analysis based on the information available in the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as specific, quantitative metrics. The overall acceptance criteria appear to be substantial equivalence to predicate devices, particularly in material composition, indications for use, and a general assessment of technical characteristics.	"Performance tests on representative screws showed them to have similar results as predicate screws."
Material composition: Plates made from unalloyed titanium (ASTM F67).	Plates: Made from medical grade unalloyed titanium (commercially pure Titanium grade 4, ASTM F-67) for the Maxillofacial System. Made from unalloyed titanium (ASTM F67) for Orthognathic, Mandible Reconstruction, and Mesh Systems. Screws: Made from alloyed titanium (Titanium 6Al 4V, ASTM F-136) for Maxillofacial System. Made from titanium alloy, Ti-6Al-4V, (ASTM F136) for Orthognathic, Mandible Reconstruction, and Mesh Systems. (All reported to be identical to predicate devices).
Dimensions and shapes: Plates between 0.4 and 1.7 mm thick, screws with diameters 1.5-3.0 mm and lengths 3-22mm.	Plates: Maxillofacial: 0.4 to 1.0 mm thick. Orthognathic: 0.8 to 1.0 mm thick. Mandible Reconstruction: 1.25 to 1.70 mm thick. Mesh: 0.45, 0.60 and 0.867 mm thick. Screws: Maxillofacial: 1.5 to 2.3 mm diameter, 3 to 24 mm length. Orthognathic: 2.0 to 2.7 mm diameter, 6 to 22 mm length. Mandible Reconstruction: 2.3 to 3.0 mm diameter, 5 to 18 mm length. Mesh: 1.5 to 2.3 mm diameter, 3 to 6 mm length. (All reported to be "similar" or "identical" to predicate devices).
Indications for Use: (As per the legally marketed predicate devices).	Maxillofacial System: Selective trauma of the mid-facial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Orthognathic System: Selective trauma of the mid-facial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Mandible Reconstruction System: Selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Mesh System: Selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. (All reported to have "the same indications for use as the relevant predicate devices").
No new issues of safety and efficacy raised by minor differences.	Minor differences in dimensions and shapes exist but "raise no new issues of safety and efficacy of the device."

2. Sample size used for the test set and the data provenance

Not provided. The document mentions "Performance tests on representative screws," but does not specify the number of screws tested nor the origin/nature of the test data (e.g., patient data, in-vitro testing). Given the device type (bone plates and screws), it is highly likely these were bench tests (mechanical, material, etc.) rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. For devices like bone plates and screws which are assessed through engineering/material performance tests, "ground truth" established by clinical experts (like radiologists) would not be the primary evaluation method for the performance tests mentioned. If any expert review was part of the design or substantial equivalence argument, it is not detailed.

4. Adjudication method for the test set

Not applicable/Not provided. Since the nature of the "performance tests" is not detailed, and no ground truth establishment via consensus is mentioned, an adjudication method for test set ground truth is not described.

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 document describes medical devices (bone plates and screws), not an AI-based diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant or performed.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

Implicitly: Engineering standards and predicate device performance. The primary "ground truth" for these types of mechanical/material-based devices is adherence to recognized standards (like ASTM F-67, F-136) for material properties and demonstrating comparable or equivalent performance to already marketed (predicate) devices through appropriate engineering tests. Explicit "expert consensus," "pathology," or "outcomes data" are not mentioned as being used to establish ground truth for the performance tests cited.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" as this is not a machine learning or AI device.

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

Not applicable. As above, no training set or AI development is described.

In summary, the provided document is a 510(k) summary for conventional medical devices (bone plates and screws). The acceptance criteria are broadly defined by substantial equivalence to predicate devices in material, dimensions, intended use, and general performance. The "study" proving this largely relies on "performance tests on representative screws" and comparisons of technical characteristics and indications for use to predicate devices, without detailed quantitative data for specific acceptance criteria or an evaluation methodology that would involve clinical experts or AI/software validation methods.

Summary

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Revised 510K Summary . K091812

MAY - 7 2010

[JEY] (DZL) .

The following information is provided as required by 21 CFR 807.87 for the 510(k) premarket notification for five The following mormation is provided as required of all of the one of the mathic System and Frontier Devices Mandible Reconstruction System and Mesh System.

Date Prepared:

May 6, 2010

Frontier Devices

Sponsor :

	153A Cahaba Valley Parkway
	Pelham, AL 35124
FDA Registration #:	3006803588
Contact Person:	Don Petersen, Ph.D.
	Director Quality Assurance and Regulatory Affairs
	205-733-0901 (phone)
	205-733-8445 (fax)
	dpetersen@frontierdevices.com
Proprietary Names:	Frontier Devices Maxillofacial System
	Frontier Devices Orthognathic System
	Frontier Devices Mandible Reconstruction System
	Frontier Devices Mesh System
Common Names:	Bone plates and screws
Classification Names:	Bone plate (872.4760)
(Regulation Number) [Product Code]	Intraosseous fixation screw (872.4880)

Device Classification:	Class II
Panel:	Dental

Predicate Devices

Frontier Devices Maxillofacial System BioPlate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (K030806)

Frontier Devices K091812 - 510(k) Response Letter

Appendix D Page D-1

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Frontier Devices Orthognathic System Ortrautek Orthognathic System (K031989)

Frontier Devices Mandible Reconstruction System BioPlate Mandible Fixation System (K012910)

Frontier Devices Mesh System Synthes Craniofacial Plate and Screw System (K050608)

Device Descriptions

Frontier Devices Maxillofacial System

The devices in the Maxillofacial System are implantable bone screws for oral and maxillofacial procedures including fractures, orthognathic, reconstructive procedures and revisions procedures when other treatments of devices have failed.

Surgical locations for device placement includes fracture and reconstruction sites in the mandible, maxilla, zycomatic bone and orbital socket.

Plates range in shape and size to aid the surgeon in repairing bone. Plate shapes include Oblique I, T, Curve, Straight, Y, Double Y, Box, X, H and Z. The sizes for the plates range from 0.4 to 1.0 mm thick and up to 100 mm in length. Plates are made from medical grade unalloyed titanium (commercially pure Titanium grade 4, ASTM F-67).

The screws are made from alloyed titanium (Titanium 6Al 4V, ASTM F-136). The screws have two designs, a selftapping screw that is to be used after pre-drilling pilot holes and a self-drilling screw that does not require a predrilled hole. Screws have diameters ranging from 1.5 to 2.3 mm and lengths from 3 to 24 mm.

Frontier Devices Orthognathic System

The Frontier Devices Orthognathic System consists of titanium bone plates and screws of various shapes and sizes. The plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Plates range in shape and size to aid the surgeon in repairing the maxilla and mandible. Plate shapes include L-Tooth, L-Zigomatic, and Straight. The sizes for the plates range from 0.8 to 1.0 mm thick and up to 42 mm in length.

The screws are self-tapping screws that require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 2.0 to 2.7 mm in diameter and range in length from 6 to 22 mm.

This system provides a wide variety of specific screws and plates intended for use for maxillofacial trauma, maxillofacial, orbital reconstruction and specialized orthognathic surgery. The indications include mandible and maxilla trauma, reconstruction of the mandible or maxillary fixation and orthognathic surgery.

Surgical locations for device placement includes fracture and reconstruction sites in the mandle.

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Frontier Devices Mandible Reconstruction System

The Frontier Devices Mandible Reconstruction System consists of titanium bone plates and screws of various shapes and sizes intended for use for maxillofacial, orbital reconstruction and specialized orthognathic surgery. The indications include mandible trauma, such as, severe comminution and bone loss and unstable mandible fractures; mandible reconstruction such as, bridging defects after tumor resection or severe infection; intermaxillary fixation, and orthognathic surgery.

Surgical locations for device placement includes fracture and reconstruction sites in the mandible.

The plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Plates are 1.25 to 1.70 mm thick and up to 56 mm in length. The plates come in a variety of shapes and sizes to aid the surgeon in repairing the maxilla and mandible. Plate shapes include straight and angled.

The screws are self-tapping screws that require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 2.3 to 3.0 mm in diameter and range in length from 5 to 18 mm.

Frontier Devices Mesh System

The Frontier Devices Mesh System consists of titanium meshes and screws of various shapes and sizes. Reconstruction of maxillofacial defects can be carried out with titanium mesh to reconstruct the missing framework of the maxillofacial area. The defects can be caused by acute trauma, tumor removal, and previous operations. The Mesh System is indicated for immediate reconstruction in the primary treatment of comminuted fractures with bone loss in non load-bearing areas, treatment of contour irregularities (possibly in combination with bone or cartilage grafts), and applicability for orbital and sinus defects. The desired strength, contour ability and desired location are all factors that determine which size and thickness of mesh the surgeon selects.

Surgical locations for device placement includes fracture and reconstruction sites in the mandible, maxilla, orbital and sinus regions.

The meshes are made from unalloyed titanium that conforms to the ASTM F67 standard. Meshes are 0.45, 0.60 and 0.867 mm thick and come in a variety of shapes and sizes that are designed for mesh applications. The 0.4 mm thick mesh is less rigid and more contour-able and intended for small voids/defects. The 0.6 mesh is more rigid and is intended for larger voids/defects. The 0.87 mm mesh offers the greatest strength and is intended for larger defects.

The screws are self-drilling screws that do not require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 1.5 to 2.3 mm in diameter and range in length from 3 to 6 mm.

Intended Use:

Frontier Devices Maxillofacial System

Frontier Devices Maxillofacial System is intended for use in selective trauma of the mid-facial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

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Frontier Devices Orthognathic System

Frontier Devices Orthognathic System is intended for use in selective trauma of the mid-facial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Mandible Reconstructive System

The Frontier Devices Mandible Reconstructive System is intended for use in selective trauma of the mid-face and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Frontier Devices Mesh System

Technology Characteristics

The plates and screws of the five different Frontier Devices systems have similar dimensions, designs and materials as the predicate devices The plates are between 0.4 and 1.7 mm thick, made from unalloyed titanium (ASTM F67) and have similar design shapes and sizes as the predicate devices. The screws are all made from titanium alloy (ASTM F136) with diameters between 1.5 and 3.0 mm and lengths of 3-22mm which are similar to the predicate devices.

Performance Tests

Performance tests on representative screws showed them to have similar results as predicate screws.

Substantial Equivalence

The Frontier Devices Maxillofacial, Orthognathic, Mandible Reconstruction and Mesh Systems consist of plates and screws that are identical in material composition and have the same indications for use as the relevant predicate devices. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. There may be slight differences in dimensions and shapes between the Frontier Devices Systems and the predicate devices, however, these minor differences raise no new issues of safety and efficacy of the device.

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Image /page/4/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 bars forming its body and wings. The eagle is oriented diagonally, facing upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Don Peterson, Ph.D. Director of Quality Assurance and Regulatory Affairs Frontier Devices, Incorporated 153A Cahaba Valley Parkway Pelham, Alabama 35124

MAY - 7 2010

Re: K091812

Trade/Device Name: Frontier Devices Maxillofacial System Frontier Devices Orthognathic System Frontier Devices Mandible Reconstruction System Frontier Devices Mesh System

Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: April 30, 2010 Received: May 4, 2010

Dear Dr. Peterson:

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- Dr. Peterson

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.ida.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/ReportaProblem/default.htm 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.

Nh 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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Indications for Use

510(k) Number (if known): K091812

Device Name: Frontier Devices Maxillofacial System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly for MSR

Page 1 of 1

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

510(k) Number: K091812

Frontier Devices K091812 - 510(k) Response Letter

Appendix C Page C-1

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Indications for Use

510(k) Number (if known): K091812

Device Name: Frontier Devices Orthognathic System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muhy for MSR

Division Sign-Off) Tivision of Anesthesiology, General Hospital ifection Control, Dental Devices

Page 1 of 1

) ਪ 510(k) Number:

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Indications for Use

510(k) Number (if known): K091812

Device Name: Frontier Devices Mandible Reconstruction System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muler for NSR

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

510(k) Number: K091812

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Indications for Use

510(k) Number (if known): K091812

Device Name: Frontier Devices Mesh System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muhn for NSR

Page 1 of 1

Ovision Sion-Off vivision of Anesthesiology, General Hoapital nfection Control, Dental Deviews

510(k) Number:

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.