The Frontier Devices Neuro 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 are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that are designed for cranial closure applications. The shapes and corresponding sizes include: Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes), Box plates 10mm x 10mm to 16mm x 16mm (4 hole), X-plate 8mm x 8mm (4 hole), Y-plate 16mm long (6 and 8 holes), Double Y-plate 18mm to 21mm long (6 and 8 hole), Strut plate 24 and 35mm long (6 and 8 hole). The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include: Burr hole covers 12mm to 24mm diameter, Burr hole covers for shunt 12mm to 24mm diameter. The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm. 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 1.8 mm in diameter and range in length from 3 to 6 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Frontier Devices Neuro Closure System:

Summary of Device Performance and Acceptance Criteria

This 510(k) submission for the Frontier Devices Neuro Closure System (K100205) describes a medical device seeking substantial equivalence to predicate devices, rather than establishing entirely new performance criteria. Therefore, the "acceptance criteria" are primarily based on demonstrating similarity to existing, legally marketed devices.

The performance testing focused on demonstrating that the new device performs similarly to the predicate devices and meets relevant safety standards for its materials.

Acceptance Criteria Category	Reported Device Performance (Frontier Devices Neuro Closure System)
Material Composition	Plates made from unalloyed titanium (ASTM F67). Screws made from titanium alloy, Ti-6Al-4V (ASTM F136).
Material Biocompatibility/Safety	Endotoxin levels < 0.06 EU/ml for screws, plates, and mesh devices.
Mechanical Performance (Screws)	Screw insertion tests showed similar results to predicate screws.
Dimensions & Design	Plates: 0.4 and 0.6 mm thick; various shapes and sizes for cranial closure. Burr hole covers: 0.4 and 0.6 mm thick, circular. Screws: 1.5 to 1.8 mm diameter, 3 to 6 mm length. Mesh: 0.4 and 0.6 mm thick, 90mm x 120mm.
Intended Use	Intended for use in selective trauma of the cranial skeleton and cranial surgery (same as predicate devices).
Substantial Equivalence	"All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices." "information provided in this submission proves substantial equivalence to the predicate devices."

Details of the Study/Testing:

Based on the provided text, the "study" conducted for this device appears to be a series of bench tests and material characterization tests aimed at demonstrating "substantial equivalence" to predicate devices, rather than a clinical trial or a study involving human or animal subjects for efficacy or safety in a real-world scenario.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test, but referred to as "representative screws" for insertion tests and "screws, plates and mesh devices" for endotoxin testing. No specific number for each item is provided.
- Data Provenance: The tests were conducted internally by the manufacturer (Frontier Devices) or a contracted lab. The document does not specify the country of origin of the raw materials, but the company is based in Pelham, AL, USA. The testing is presumably prospective for this specific device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device relies on physical and chemical testing against established material standards (ASTM F67, ASTM F136) and comparative bench testing against predicate devices. There is no "ground truth" established by human experts in the way clinical diagnostic devices require. The "ground truth" for material standards is the standard itself.
Adjudication method for the test set:
- Not applicable. As this involves objective physical and chemical measurements against standards and predicate device performance, there isn't a need for expert adjudication of results. The results are quantitative (e.g., endotoxin levels, screw insertion test results).
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 is a physical implantable device (plates and screws), not a diagnostic or AI-driven system that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the material components is adherence to established ASTM material standards (ASTM F67 for unalloyed titanium, ASTM F136 for Ti-6Al-4V titanium alloy) and meeting biological safety standards (LAL endotoxin limit of < 0.06 EU/ml). For mechanical performance (screw insertion), the ground truth is simply achieving results similar to the predicate devices.
The sample size for the training set:
- Not applicable. This device did not involve machine learning or AI algorithms, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there was no training set.

Summary

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K100205

Section 5 510k Summary

DEC 1 3 2010

The following information is provided as required by 21 CFR 807.87 for the 510(k) premarket notification for the plate and screw system, Frontier Devices Neuro Closure System. It has been revised from the original S10k Summary submitted in January 2010 in accordance with FDA requests.

Date Prepared:	November 30, 2010
Sponsor :	Frontier Devices153A Cahaba Valley ParkwayPelham, AL 35124
FDA Registration #:	1065595
Contact Person:	Don Petersen, Ph.D.Director Quality Assurance and Regulatory Affairs205-733-0901 (phone)205-733-8445 (fax)dpetersen@frontierdevices.com
Proprietary Names:	Frontier Devices Neuro Closure System
Common Names:	Bone plates and screws
Regulation Number:	882.5320
Classification Name:	Preformed alterable cranioplasty plate
Product Codes:	GWOPlate, cranioplasty, preformed, alterableHBWFastener, Plate, CranioplastyGXRCover, Burr hole	GWO	Plate, cranioplasty, preformed, alterable	HBW	Fastener, Plate, Cranioplasty	GXR	Cover, Burr hole
GWO	Plate, cranioplasty, preformed, alterable
HBW	Fastener, Plate, Cranioplasty
GXR	Cover, Burr hole
Device Classification:	Class II
Panel:	Intraocular, Corneal, and Neuromaterials Devices Branch
Predicate Devices:	Synthes Low Profile Neuro System (K042987)Synthes 2.0 mm Titanium T-Plate (K072758)Synthes Cranial Spring (K974206)
Device Descriptions:	Frontier Devices Neuro SystemThe Frontier Devices Neuro System consists of titanium bone plates and screws ofvarious shapes and sizes.Plates
	The plates are made from unalloyed titanium that conforms to the ASTM F67 standard.Plates are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that aredesigned for cranial closure applications. The shapes and corresponding sizes include:
	Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes)Box plates 10mm x 10mm to 16mm x 16mm (4 hole)X-plate 8mm x 8mm (4 hole)Y-plate 16mm long (6 and 8 holes)

Frontier Devices 510(k) Premarket Notification Submission Neuro Closure System

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Double Y-plate 18mm to 21mm long (6 and 8 hole) Strut plate 24 and 35mm long (6 and 8 hole)

Burr Hole Covers

The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include:

Burr hole covers Burr hole covers for shunt 12mm to 24mm diameter 12mm to 24mm diameter

Mesh

The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm.

Screws

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 1.8 mm in diameter and range in length from 3 to 6 mm.

Intended Use:

Technology

Frontier Devices Neuro System

Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.

The plates and screws of the Frontier Devices Neuro Closure System have similar dimensions, designs and materials as the predicate devices. The plates Characteristics are 0.4 and 0.6 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 of 1.5 mm and 1.8 mm and lengths of 3-6 mm which are similar to the predicate devices.

Performance Tests Screw insertion tests on representative screws showed them to have similar results as predicate screws. In addition, LAL endotoxin testing was done on screws, plates and mesh devices and all the devices had endotoxin levels of less than 0.06 EU/ml.

Substantial Equivalence

The Frontier Devices Neuro Closure System consists of plates and screws that are similar in material composition and have the same indications for use as the predicate device. 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 Neuro Closure System and the predicate devices, however, the information provided in this submission proves substantial equivalence to the predicate devices.

Frontier Devices 510(k) Premarket Notification Submission Neuro Closure System

Page 5-2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Don Peterson, Ph.D. Directory Quality Assurance and Regulatory Affairs Folsom Metal Products, Incorporated 153 Cahaba Valley Parkway Pelham, Alabama 35124

DEC 1 3 2010

Re: K100205

Trade/Device Name: Frontier Devices Neuro Closure System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: II Product Code: GWO, HBW, GXR Dated: November 30, 2010 Received: December 2, 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.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/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 yours,

Smaronne

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

K100205

510(k) Number (if known): 100205

DEC 1 3 2010

Device Name: Frontier Devices Neuro Closure System

Indications For Use:

The Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluati

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

510(k) Number:

Frontier Devices K100205 - Response Letter #2 - 7-8-10 Appendix E Page E-2

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).