The OsteoFab™ Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

Device Description

An OsteoFab® Patient Specific Facial Device (OPSFD) is built individually for each patient. The OPSFD is made of polyetherketone (PEKK) polymer and built by a LASER sintering machine. The OPSFD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. OPSFDs come in a variety of configurations that depend on the geometry of the application. OPSFDs are oblong and (for an individual patient) have shapes and sizes that vary within the following specifications: (1) maximum diameter is 20 cm (2) minimum thickness is 1 mm, (3) maximum thickness is 10 mm, (4) maximum open density is 25%, (5) minimum as built hole diameter is 3 mm, (6) maximum as built hole diameter is 5 mm, and (6) minimum distance from the edge of an as built hole to the edge of a device is 15 mm.

The OPSFD is attached to native bone with commercially available fixation systems and it is a permanent implant. The OPSFD is a non-load bearing single use device and it does not impart mechanical strength to the implant area. The OPSFD implant is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validation for gravity displacement steam sterilization was conducted at 135°C (275°F) with a half cycle of five (5) minutes. The validation for prevacuum steam sterilization was conducted at 132°C (270°F) with a half cycle of two (2) minutes.

AI/ML Overview

The provided text describes specific bench testing for the OsteoFab® Patient Specific Facial Device (OPSFD), which is an individually designed implant made of polyetherketone (PEKK) polymer. The document focuses on demonstrating the substantial equivalence of the OPSFD device to previously cleared predicate devices by comparing various material and performance characteristics.

Here’s a breakdown of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the quality control (QC) specifications established for the device's manufacturing process, as well as comparisons to predicate devices and recognized ASTM standards.

Characteristic	Acceptance Criteria	Reported Device Performance
I. Quality Control (Manufacturing)
Glass Transition Temperature (Tg)	157-160 °C	Mean: 158.16 °C (Within range)
Fourier Transform Infrared Spectroscopy (FTIR)	≥ 95% Match to a designated PEKK standard	Mean: 98.11% Match (Meets criterion)
Average Specific Gravity	1.27-1.31	Mean: 1.29 (Within range)
Average Tensile Stress at Break (X-orientation)	≥ 9.0 KPSI	Mean: 11.67 KPSI (Meets criterion)
Average Tensile Elongation @ Break	≥ 1.5 %	Mean: 2.63% (Meets criterion)
Average Young's Modulus of Elasticity	≥ 281 KPSI	Mean: 509.09 KPSI (Meets criterion)
II. Device Specific Performance
Wall Thickness (Tensile Strength)	For 1mm, 2mm, 4mm thick specimens, tensile strength values must be substantially equivalent to 3.2mm QC release criteria (Tensile Stress ≥ 9.0 KPSI, Elongation @ Break ≥ 1.5 %, Young's Modulus ≥ 281 KPSI).	1mm thickness: Tensile Stress = 10.5 KPSI, Elongation = 2.4 %, Young's Modulus = 329 KPSI. 2mm thickness: Tensile Stress = 10.8 KPSI, Elongation = 2.4 %, Young's Modulus = 409 KPSI. 4mm thickness: Tensile Stress = 11.6 KPSI, Elongation = 2.4 %, Young's Modulus = 490 KPSI. (All met or exceeded 3.2mm release criteria, establishing 1mm as minimum allowable thickness).
Through Hole Size	Manufacturable range of 2mm to 5mm.	Average diameter for 5mm nominal holes: 4.74 mm (Tolerance 4.50-5.50 mm). Average diameter for 2mm nominal holes: 1.92 mm (Tolerance 1.50-2.50 mm). (Demonstrated manufacturability within the specified range).
Spacing between Through Holes	Minimum spacing of 2mm.	Average spacing for 5mm nominal spacing: 4.81 mm (Tolerance 4.50-5.50 mm). Average spacing for 2mm nominal spacing: 1.79 mm (Tolerance 1.50-2.50 mm). (Demonstrated manufacturability of the specified minimum spacing).
Screw Insertion (Fractures)	Self-drilling screws: Limited fractures (e.g., 0/28 for straight edge, 2/28 for 45° angle) Self-tapping screws (with pilot hole): No fractures.	Self-drilling: 0/28 fractures (straight edge), 2/28 fractures (45° angle). Self-tapping: 0/28 fractures (straight edge), 0/28 fractures (45° angle). (Acceptable performance, particularly for self-tapping).
Drop Characterization (Material Loss/Damage)	Material loss ≤ 0.020%. No significant damage (e.g., major fractures) after inspection.	Horizontal, dome up: 0.020% material loss. Horizontal, dome down: 0.002% material loss. Vertical: 0.008% material loss. All showed only "slight indentation on the point of impact" at 10x inspection. (Met criteria for minimal material loss and damage).
Edge Distance (Cracks from Screws)	No cracks when screw centerline to edge distance is sufficient.	Rev A (3.75mm screw centerline to edge, pre-drilled, self-tapping): 4/45 cracked. Rev B (5mm screw centerline to edge, pre-drilled, self-tapping): 45/45 no cracks. Rev C (5mm screw centerline to edge, no pre-drilling, self-drilling): 1/6 cracked (study discontinued). Rev D (7mm screw centerline to edge, no pre-drilling, self-drilling): 45/45 no cracks. (Demonstrates acceptable performance with sufficient edge distance and/or pre-drilling).
Modification (Edge Modification/Re-contouring)	Power tools should not cause excessive melting or instability. Cutting should be effective.	Diamond burr light pressure: No issues. Diamond burr heavy pressure: Debris melted locally. Deep flute light pressure: No problems. Deep flute heavy pressure: Burr head unstable. Sagittal saw: Edge cutting easy, surface cutting not as easy. Reciprocating saw: Edge and surface cutting easy. (Indicates acceptable modification methods with appropriate technique).
Dimensional Stability (Sterilization cycles)	After multiple sterilization cycles, ≥ 99% of datum points within ± 0.005 inches of pre-sterilization scans. No cracking, fracturing, swelling, or shrinkage.	After 3 sterilization cycles: ≥ 99% of datum points within ± 0.005 inches. No cracking, fracturing, swelling, or shrinkage. After 9 sterilization cycles: ≥ 99% of datum points within ± 0.005 inches. No cracking, fracturing, swelling, or shrinkage. (Demonstrated excellent dimensional stability).
Axial Pullout Force	Stronger than PMMA and PEEK predicate materials.	PEKK (Steam x 1, multiple batches): 244.0 N, 227.1 N, 233.1 N 평균. PMMA (Gamma x 1): 43.5 N. PEEK (Steam x 1): 193.6 N. (PEKK significantly stronger than both PMMA and PEEK).
Tensile Strength (vs. PMMA Predicate)	Tensile at Break (ASTM D638): ≥ 9,000 psi. Elongation at Break (ASTM D638): ≥ 1.5 %.	OPSFD (PEKK): Tensile at Break ≥ 9,000 psi (QC data), Elongation at Break ≥ 1.5% (QC data). PMMA (ASTM D4802): Nominal Tensile at Break = 9,000 psi, Nominal Elongation at Break = 2%. (Demonstrated substantial equivalence in tensile strength between PEKK and PMMA).
Biocompatibility	Within acceptance criteria of ISO 10993-3, 5, 6, 10, 11, and 18 standards.	Test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards. Cytotoxicity results for L-929 mouse fibroblast cells and human neuroblastoma SK-N-MC cells were within ISO 10993-5 criteria.
Endotoxin	Below medical device contacting cerebral spinal fluid acceptance criterion (<2.15 EU/Device).	Limulus Amebocyte Lysate (Gel-Clot method) results were below <2.15 EU/Device.

2. Sample Sizes Used for Test Sets and Data Provenance

The studies described are bench tests conducted on material-level and device-representative test specimens. These are not human clinical trials.

Quality Control (Manufacturing): 32 builds (test specimens derived from these builds).
Wall Thickness & Through Hole Size: 3 sets of 5 tensile bars each (1mm, 2mm, 4mm thick) for wall thickness; multiple test specimens (N/A explicitly stated, but each had >10 through holes) for hole size and spacing.
Screw Insertion: PEKK test blocks (3mm thick, 14 fingers each). For self-drilling & self-tapping experiments, 28 screw insertions were made for straight edges and 45° angle edges in each instance.
Drop Characterization: N=1 for each of three configurations (horizontal dome up, horizontal dome down, vertical).
Edge Distance:
- Rev A: Three PEKK test blocks (job 2820), 45 screw insertions.
- Rev B: Four PEKK test blocks (job 2843), 45 screw insertions.
- Rev C: One PEKK test block (job 2849), 45 screw insertions (study discontinued).
- Rev D: Four PEKK test blocks (job 2849), 45 screw insertions.
Modification: N=2 for each experiment type (edge modification, re-contouring, cutting).
Dimensional Stability: 10 cranial flap test specimens for 3 sterilization cycles and 10 cranial flap test specimens for 9 sterilization cycles.
Axial Pullout Force:
- PMMA: 20 test specimens.
- PEKK (Steam x 1, two different runs): 10 test specimens each.
- PEKK (Steam x 1, 2, 3 cycles, two different runs): 8 test specimens per sterilization condition per run (total 48 PEKK specimens across these two experiments).
- PEEK: 10 test specimens.
Tensile Strength (vs. PMMA Standard): The OPSFD data is derived from the N=32 QC builds. PMMA data is from ASTM D4802.
Biocompatibility: PEKK test specimens (specific numbers not provided for each test but generally typical for ISO 10993 evaluations).
Endotoxin: OsteoFab® test specimens (specific numbers not provided).

Data Provenance: All data appears to be from prospective bench testing conducted by Oxford Performance Materials, Inc. (the manufacturer). There is no indication of country of origin for the data other than it being generated by the submitting company.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is a materials science and mechanical engineering evaluation, not a clinical study involving diagnosis or interpretation of patient data. Therefore, the concept of "experts establishing ground truth" in a clinical sense (e.g., radiologists) does not apply.

Instead, the "ground truth" or acceptance criteria are established based on:

Industry standards (e.g., ASTM D638, ASTM F543-07, ISO 10993, USP 85, ANSI/AAMI ST79).
Internal quality control data (e.g., 32 builds used to set QC specifications).
Comparison to predicate device characteristics where information was available (e.g., PMMA and PEEK tensile strength and pullout force).

The "experts" involved would be the material scientists, engineers, and regulatory specialists who designed, executed, and analyzed these bench tests, ensuring compliance with relevant standards and demonstrating equivalence. Their specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or interpretations needing adjudication. The results are quantitative measurements against predefined criteria or comparative measurements against other materials/devices.

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, this is a physical device (implant) and materials performance evaluation, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance metrics are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations is based on:

Metrology: Direct measurements of physical properties (e.g., tensile strength, specific gravity, dimensions, pullout force) using calibrated instruments.
Standardized Test Methods: Adherence to internationally recognized standards (e.g., ASTM, ISO, USP) for testing methodologies.
Visual Inspection: Microscopic or macroscopic visual inspection (e.g., 10x magnification for cracks, indentations).
Chemical Analysis: FTIR for material identification and purity.
Biocompatibility Definitions: Established criteria within ISO 10993 series.
Comparative Data: Published nominal values for predicate materials (e.g., PMMA from ASTM D4802).

8. The Sample Size for the Training Set

Not applicable in the context of machine learning. This is a physical device.

For the purpose of establishing manufacturing quality control specifications, the "training set" (or rather, the data used to define the process's stable limits) for the final QC tests was based on 32 builds.

9. How the Ground Truth for the Training Set Was Established

Again, this refers to establishing manufacturing quality control specifications rather than AI model training. The "ground truth" for these specifications was established by:

Statistical Analysis of Production Data: The mean, standard deviation, and 3 standard deviations (3SD) were calculated from the 32 builds for the various QC parameters (Tg, FTIR, Specific Gravity, Tensile Stress, Elongation, Young's Modulus).
Engineering Judgment and Safety Margins: The acceptance criteria were then defined based on these statistical measures (e.g., Mean +/- 3SD, or Mean - 3SD for minimum performance characteristics), indicating a robust manufacturing process and ensuring product quality and safety. For FTIR, a ≥ 95% match to a designated PEKK standard was set.

Summary

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5 - OPSFD 510(k) Summary Statement as Required by Title 21 CFR 807.92(c)

510(k) Submitter: Oxford Performance Materials, Inc. P.O. Box 585 30 South Satellite Road South Windsor, CT 06074 1-860-698-9300

Contact Person: Leigh Ayres, Director of Scientific and Regulatory Affairs Date of 510(k) summary statement preparation: July 21, 2014 Proprietary name: OsteoFab® Patient Specific Facial Device Common or Usual Name: Polytetrafluoroethylene (PTFE) with Carbon Fibers Classification: 878.3500 General/Plastic Surgery Review Panel: General/Plastic Surgery Medical Device Classification: Class II Product Code: KKY Predicate Devices: Polyclinic Medical Center Hard Tissue Replacement (HTR) Patient Matched Implant (K924935), the Synthes SynPOR HD Porous Polyethylene (K111323), and the Stryker® Patient Specific Polymer Implant (K103010)

Description of the Device

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was conducted at 135°C (275°F) with a half cycle of five (5) minutes. The validation for prevacuum steam sterilization was conducted at 132°C (270°F) with a half cycle of two (2) minutes.

Intended Use Statement

The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

Biocompatibility

Biocompatibility tests were selected according to the FDA guidance document: "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (1995) and the test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards.

The results of cytotoxicity testing on OsteoFab® test specimens utilizing L-929 mouse fibroblast cells or human neuroblastoma SK-N-MC cells were within ISO 10993-5 acceptance criteria.

The Limulus Amebocyte Lysate method was performed on OsteoFab® test specimens to evaluate bacterial endotoxin utilizing the Gel-Clot method according to USP 85. The test results were below the medical device contacting cerebral spinal fluid acceptance criterion (<2.15 EU/Device).

Performance Testing - Bench Testing

QUALITY CONTROL

The test suite for the final quality control (QC) testing of the OsteoFab® Patient Specific Facial Device (OPSFD) builds includes glass transition temperature (Tg), Fourier transform infrared spectroscopy (FTIR), specific gravity, and tensile strength. This is the same QC testing that is performed when an OsteoFab® Patient Specific Cranial Device (OPSCD) is manufactured. The OPSCD device was cleared by the FDA on February 7, 2013 (K121818).

The final QC specifications for those tests were determined from 32 builds. TABLE 18.A shows the mean, the standard deviation, the standard deviation multiplied by 3, the acceptance criteria, and the formula for the acceptance criteria.

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	Tg(20°C/min)	FTIR	AverageSpecificGravity	AverageTensileStress atBreak (X-orientation)(KPSI)	AverageTensileElongation@ Break(%)	AverageYoung'sModulus ofElasticity(KPSI)
mean	158.16	98.11	1.29	11.67	2.63	509.09
SDEV	0.51	1.16	0.0072	0.89	0.39	75.93
3SD	1.53	3.48	0.022	2.67	1.17	227.79
AcceptanceCriteria	157-160	≥ 95%Match	1.27-1.31	≥ 9.0	≥ 1.5	≥ 281
Formula fortheAcceptanceCriteria	Mean +/-3SD	≥ 95%Match to adesignatedPEKKstandard	Mean +/-3SD	Mean - 3SD	Mean - 3SD	Mean - 3SD

TABLE 18.A: Summary Statistics of 32 Builds

The test specimens from the 32 builds that were subjected to tensile strength testing were 3.2 mm thick.

WALL THICKNESS AND THROUGH HOLE SIZE

In order to determine the minimum wall thickness for an OPSFD implant, three sets (5 specimens each) of tensile bars that were 1, 2, and 4 mm thick were built. The average tensile strength data for each size is compared to the final QC release acceptance criteria (see TABLE 18.B).

All three sizes (1, 2, and 4 mm) of test specimens are substantially equivalent to the 3.2 mm final QC test specimen because the data obtained was within the final QC acceptance criteria (see TABLE 18.B). Based on the measurements obtained, the minimum allowable thickness of an OPSFD implant is 1 mm.

Sample Description	Average Tensile Stress atBreak (X-orientation)(KPSI)	AverageTensileElongation @break(%)	Average Young'sModulus ofElasticity (KPSI)
1 mm thickness (average)	10.5	2.4	329
2 mm thickness (average)	10.8	2.4	409
4 mm thickness (average)	11.6	2.4	490
Release Criteria for 3.2 mmthickness	≥ 9.00	≥ 1.5	≥ 281

TABLE 18.B: Summary Statistics of the 1, 2, and 4 mm Thick Test Specimens

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The tensile testing was conducted according to ASTM D638 "Standard Test Method for Tensile Properties of Plastics."

Test specimens were also built to determine the range of pore (through holes) sizes and the minimum spacing of through holes. These test specimens were 4 mm thick and each had more than 10 through holes. Based on the measurements obtained, the range of through holes that can be built with the P-800 is 2 mm to 5 mm and the minimum spacing of through holes is 2 mm. TABLE 18.C and TABLE 18.D show the average of the through hole size measurements and the average of the spacing between through hole measurements, respectively.

	TABLE 18.C: Vernier Caliper Measurements of the Diameter of Through Holes
In The Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Child	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------contraction of the consistence of the consistence and the consistent of the first of the support of the first of the first of the first of the first of the first of the first

	5 mm Through Hole TestSpecimen with 5 mm Spacing(Diameter in mm)	2 mm Through Hole TestSpecimen with 2 mm Spacing(Diameter in mm)
Average (n=10)	4.74	1.92
Standard Deviation	0.03	0.05
Nominal Value with Tolerance	5.00 (4.50 - 5.50)	2.00 (1.50 - 2.50)

TABLE 18.D: Vernier Caliper Measurements of the Spacing between Through Holes

	5 mm Through Hole TestSpecimen with 5 mm Spacing(Spacing in mm)	2 mm Through Hole TestSpecimen with 2 mm Spacing(Spacing in mm)
Average (n=10)	4.81	1.79
Standard Deviation	0.02	0.03
Nominal Value with Tolerance	5.00 (4.50 – 5.50)	2.00 (1.50 - 2.50)

SCREW INSERTION

There were two experiments conducted to evaluate the effect of applying screws to PEKK test blocks: manually apply self-drilling screws and manually apply self-tapping screws after drilling a pilot hole.

The PEKK test blocks were 3 mm thick and had a straight edge or an edge that had a 45° angle. Each test block had 14 fingers. The PEKK test blocks were made from a build that had the job number 2634. After drilling, the screws and plates were removed and the PEKK test blocks were inspected with a 10x magnification eye loop.

Each screw (1.5 mm diameter x 4 mm) was driven into first a Thinflap plate and second into a finger of the test block. The distance between the edge of the PEKK test block and the tangent of the screw nearest to the edge was 3 mm.

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The results of the self-drilling experiment were as follows:

1. Fractures for the straight edge were 0/28.
1. Fractures for the 45° angle edge were 2/28.

The results for the self-tapping experiment were as follows:

1. Fractures for the straight edge were 0/28.
1. Fractures for the 45° angle edge were 0/28.

DROP CHARACTERIZATION

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were three experiments conducted to evaluate the effect of dropping PEKK test specimens from four feet above the floor. The PEKK test specimens were in a cranial flap configuration (job number 2724). The PEKK test specimens were dropped horizontally in the dome up position, horizontally in the dome down position, and vertically.

The test specimens N=1 for each experiment were first steam sterilized at 134°C for 4 minutes and then dried for 30 minutes. The material loss from all three experiments was equal to or less than 0.020%. The results from the three experiments are summarized on TABLE 18.K.

TABLE 18.K: Drop Test Results
SEQ	Experiment Description	Percent Difference (loss) inTest Specimen Weight(grams)	Results of 10x Inspection
1.	Horizontal, dome up	$0.017/84.036 * 100 =$0.020%	Slight indentation on thepoint of impact
2.	Horizontal, dome down	$0.002/84.736 * 100 =$0.002%	Slight indentation on thepoint of impact
3.	Vertical	$0.007/84.418 * 100 =$0.008%	Slight indentation on thepoint of impact

EDGE DISTANCE

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were four experiments conducted to evaluate the effect of applying screws to PEKK test blocks. The experimental conditions, inspections, and the results of the inspections for each of the four experiments are shown on TABLE 18.L.

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There were 45/45 fingers in the PEKK test blocks (job 2843) in the Rev B evaluation that did not have cracks.

There were 45/45 fingers in the PEKK test blocks (job 2849) in the Rev D evaluation that did not have cracks.

Each experiment utilized PEKK test blocks (each had fourteen fingers).

TABLE 18.1: LT1274 Summary of Experimental Conditions and Test Results
SEQ	Rev A: TestSequence/Results	Rev B: TestSequence/Results	Rev C: TestSequence/Results	Rev D: TestSequence/Results
1.	Inspect 10xmagnification: pass	Inspect 10xmagnification: pass	Inspect 10xmagnification: pass	Inspect 10xmagnification: pass
2.	Three PEKK job 2820Test Blocks 3 mmthick, 45° edge	Four PEKK job 2843Test Blocks 3 mmthick, 45° edge	One PEKK job 2849Test Blocks 3 mmthick, 45° edge	Four PEKK job 2849Test Blocks 3 mmthick, 45° edge
3.	132°C (4 min) dry(30 min) x 1	132°C (4 min) dry(30 min) x 1	132°C (4 min) dry(30 min) x 1	132°C (4 min) dry(30 min) x 1
4.	Inspect 10xmagnification: pass	Inspect 10xmagnification: pass	Inspect 10xmagnification: pass	Inspect 10xmagnification: pass
5.	Pre-drill 1.1 mmDrill with 5 mm stopat 3.75 mm (ScrewCenterline to Edge)x 45	Pre-drill 1.1 mmDrill with 5 mm stopat 5 mm (ScrewCenterline to Edge)x 45	No pre-drilling	No pre-drilling
6.	Overlay 2-hole 1.5thin plate	Overlay 2-hole 1.5thin plate	Overlay 2-hole 1.5thin plate	Overlay 2-hole 1.5thin plate
7.	Manually add 1.65mm diameter x 5mm High TorqueScrews and do notstrip out	Manually add 1.65mm diameter x 5mm High TorqueScrews and do notstrip out	Manually add 1.5mm diameter x 4mm High TorqueScrews and do notstrip out at 5 mm(Screw Centerline toEdge) x 45	Manually add 1.5mm diameter x 4mm High TorqueScrews and do notstrip out at 7 mm(Screw Centerline toEdge) x 45
8.	Remove screws	Remove screws	Remove screws	Remove screws
9.	Results of 10xmagnificationInspection: 4/45cracked	Results of 10xmagnificationInspection: 45/45no cracks	Results of 10xmagnificationInspection: 1/6cracked - the studywas discontinued	Results of 10xmagnificationInspection: 45/45no cracks

TABLE 18.L: LT1274 Summary of Experimental Conditions and Test Results

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MODIFICATION

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were three experiments conducted to evaluate the effect of modifying PEKK test specimens. The PEKK test specimens were in a cranial flap configuration (job number 2823).

The first experiment evaluated edge modification utilizing a power tool and a diamond burr or a deep flute burr. Each burring method was applied with light pressure and heavy pressure.

The second experiment evaluated re-contouring utilizing a power tool and a diamond burr or a deep flute burr. Each re-contouring method was applied with light pressure and heavy pressure.

The third experiment evaluated cutting with a power tool and a sagittal saw or a reciprocating saw.

The test specimens N=2 for each experiment were first steam sterilized at 134°C for 4 minutes and then dried for 30 minutes.

The results from the three experiments are summarized on TABLE 18.M.

SEQ	ExperimentDescription	Characteristic Measured	Characteristic Measured
1.	EdgeModification	Diamond burr light pressure:No issues were observed withboth test specimens.	Diamond burr heavy pressure:The debris material surroundingthe cut melted due to friction forboth test specimens.
2.	EdgeModification	Deep flute light pressure:No problems were observed withboth test specimens.	Deep flute heavy pressure:The deep flute burr head wasunstable for both testspecimens.
3.	Re-contouring	Diamond burr light pressure:The burr cut the surface verywell with both test specimens.	Diamond burr heavy pressure:The debris material surroundingthe cut melted due to friction forboth test specimens.
4.	Re-contouring	Deep flute light pressure:No problems were observed withboth test specimens.	Deep flute heavy pressure:The deep flute burr head wasunstable for both testspecimens.

TABLE 18.M: Test Results from Modifying PEKK Test Specimens

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SEQ	ExperimentDescription	Characteristic Measured	Characteristic Measured
5.	Cutting	Sagittal saw: Edge cutting waseasy for both test specimens.Surface cutting was not as easyfor both test specimens.	Reciprocating saw: Edge andsurface cutting was easy for bothtest specimens.

DIMENSIONAL STABILITY

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

Ten test specimens in a cranial flap configuration were subjected to three steam sterilization cycles. The part numbers were IG2823M-8F001 to IG2823M-8F010. All ten test specimens were steam sterilized at 134°C for 4 minutes. All ten test specimens were scanned with a Romer arm prior to sterilization.

After each sterilization cycle, the ten test specimens were cooled for 30 minutes prior to dimensional analysis by a Romer arm scanner. An eye loop that had a 10x magnification was utilized to inspect all 10 test specimens after each sterilization cycle.

The following results were obtained:

1. After each of the three sterilization cycles and for each test specimen, 99% or more of the datum points collected during the Romer arm scans were within ± 0.005 inches of the datum points collected from the pre-sterilization Romer arm scans.
1. No cracking, fracturing, swelling, or shrinkage was observed in any of the test specimens.

Ten test specimens in a cranial flap configuration were subjected to nine steam sterilization cycles. The part numbers were IG2823M-8F001 to IG2823M-8F010. The first three steam sterilization cycles were conducted at 134°C for 4-8 minutes. The second three steam sterilization cycles were conducted at 134°C for 4 minutes. The third three steam sterilization cycles were conducted at 137℃ for 18 minutes.

A Romer arm was utilized to scan all ten test specimens before and after nine sterilization cvcles. An eye loop that had a 10x magnification was utilized to inspect all 10 test specimens after the ninth sterilization cycle.

The following results were obtained:

1. After the ninth sterilization cycle, 99% or more of the datum points collected by the Romer arm from each of the ten test specimens were within ± 0.005 inches of the presterilization Romer arm datum points.
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1. No cracking, fracturing, swelling, or shrinkage was observed in the test specimens after nine sterilization cycles.

AXIAL PULLOUT FORCE AND PREDICATE COMPARISONS

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were four experiments conducted to evaluate axial pullout force. The first and the fourth experiments included the evaluation of materials that are utilized for the manufacture of predicate devices.

For the first experiment, PEKK test specimens were steam sterilized once at 134°C for four minutes and dried for 30 minutes and the PMMA test specimens were gamma sterilized once between 26.2 and 31.9 kilo Grays.

For the second experiment, PEKK test specimens were steam sterilized at 134°C for four minutes and dried for 30 minutes. All 12 test specimens were sterilized once. Eight test specimens were sterilized twice and four test specimens were sterilized three times. Repeat sterilizations were conducted to evaluate the stability of the PEKK test specimens.

For the third experiment, PEKK test specimens were steam sterilized at 137°C for 18 minutes and dried for 30 minutes. All 12 test specimens were sterilized once. Eight test specimens were sterilized twice and four test specimens were sterilized three times. Repeat sterilizations were conducted to evaluate the stability of the PEKK test specimens.

For the fourth experiment, ten PEEK test specimens were steam sterilized once at 134°C for four minutes and dried for 30 minutes.

After sterilization, each of the four experiments had all test specimens pre-drilled in two locations utilizing a 1.1 mm diameter drill that had a 5 mm stop. After pre-drilling, 1.5 mm diameter x 3.5 mm screws were manually driven into each combination of screw grip fixture and the pre-drilled through holes on each test specimen.

Each of the four experiments were conducted according to ASTM F543-07, "Standard Specification and Test Method for Metallic Medical Bone Screws, Annex A3: Test Method for determining the Axial Pullout Strength of Medical Bone Screws." The results are shown on TABLE 18.N.

Section 5 - OPSFD 510(k) Summary Statement 2014Jul21-2 Page 9 of 14

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SEQ	TestSpecimen/ReportNumber	N (SampleSize)	Mean PeakAxialPulloutForce(Newtons)	StandardDeviation	CoefficientofVariation(%)	Sterilizationmethod/Number ofcycles
1.	PMMA/LT1294	20	43.5	16.2	37	Gamma x 1
2.	PEKK/LT1294	10	244.0	32.1	14	Steam x 1
3.	PEKK/LT1294	10	227.1	28.0	12	Steam x 1
4.	PEKK/LT1295 Rev A	8	233.1	11.0	5	Steam x 1
5.	PEKK/LT1295 Rev A	8	233.1	23.6	10	Steam x 2
6.	PEKK/LT1295 Rev A	8	207.5	27.9	13	Steam x 3
7.	PEKK/LT1295 Rev B	8	196.2	68.1	35	Steam x 1
8.	PEKK/LT1295 Rev B	8	222.0	55.2	25	Steam x 2
9.	PEKK/LT1295 Rev B	8	226.4	73.8	33	Steam x 3
10.	PEEK/LT1296	20	193.6	27.5	14	Steam x 1

TABLE 18.N: Summary from the LT1294, LT1295, and LT1296 Evaluations of PMMA (Poly(methy) methacrylate), PEKK (polyetherketone) and PEEK (polyetheretherketone) Test Specimens

All test specimens had the same failure mode "the screw pulled out of material" at the peak axial pullout force. PEKK test specimens were stronger than the PMMA test specimens and the PEEK test specimens.

TENSILE STRENGTH PEKK DATA VERSUS A PMMA STANDARD

A comparison table of tensile strength was prepared in order to assess substantial equivalence between the (1) subject device OPSFD manufactured from OsteoFab® and (2) predicate devices made from PMMA. TABLE 18.0 shows the acceptance criteria for tensile strength derived from QC data obtained from OsteoFab® test specimens that represent the subject device (see also TABLE 18.A). TABLE 18.O also shows tensile strength values published in the ASTM D4802 document "Standard Specification for PMMA."

Characteristic Measured	Acceptance Criteria forOPSFD Calculated from N=32Test Specimens	Nominal values obtained fromPMMA test specimens according toASTM D4802
Tensile at Break	ASTM D638QMSP-1067 (OPSFD)$\geq$ 9,000 psi	ASTM D6389,000 psi
Elongation at Break	ASTM D638QMSP-1067 (OPSFD)$\geq$ 1.5 %	ASTM D6382%

TABLE 18.0: Comparison Table of Tensile Strength

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The PEKK and PMMA materials, based on tensile strength, are substantially equivalent because:

1. The PMMA and PEKK test specimens were prepared and tested according to ASTM D638 "Standard Test Method for Tensile Properties of Plastics."
1. The PMMA nominal value for tensile at break is the same value as the QC acceptance criterion for OsteoFab® test specimens.
1. The 2% elongation at break for PMMA is within the acceptance criterion for OsteoFab® test specimens.

Substantial Equivalence Discussion

The OsteoFab® Patient Specific Facial Device (OPSFD) is substantially equivalent in safety and effectiveness to three other predicate devices cleared by the FDA under Title 21 CFR 878.3500 polytetrafluoroethylene with carbon fibers composite implant material. Those three predicate devices are: the Polyclinic Medical Center Hard Tissue Replacement (HTR) Patient Matched Implant (K924935), the Synthes SynPOR HD Porous Polyethylene (K111323), and the Stryker® Patient Specific Polymer Implant (K103010). Information about the predicate devices was obtained from 510(k) summary statements and/or the 510(k) FDA Access Database.

The intended use statement for the OPSFD is within the scope of the intended use statements for the Synthes and Stryker® devices. The intended use statements encompass enhancement, to correct trauma, and/or to correct defects in the in mandibular, maxillofacial, or craniofacial bone. The intended use statement for the Polyclinic Medical Center HTR Patient Matched Implant was not available in the sources described above.

All three devices are fabricated from polymers. The OPSFD and Stryker® Patient Specific Polymer Implant are custom manufactured using patient CT data. The sources described above did not include information about the manufacturing processes for Synthes SynPOR or Polyclinic Medical Center HTR.

The sources described above did not include information about biocompatibility evaluations for the predicates. The test results obtained from OPSFD test specimens were found to be within ISO 10993-3, 5, 6, 10, 11, and 18 acceptance criteria and the endotoxin values obtained were below the medical device contacting cerebral spinal fluid acceptance criterion (<2.15 EU/Device).

The OPSFD is not porous. The Synthes and Stryker® implant devices are described as porous.

The OPSFD is shipped non-sterile in packaging that is ISTA 2A compliant. The OPSFD instructions for use describe validated steam sterilization procedures. The Synthes and Stryker® devices are shipped as sterile medical devices. Sterile packaging validation was listed for the Synthes predicate.

Section 5 - OPSFD 510(k) Summary Statement 2014Jul21-2 Page 11 of 14

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The substantial equivalence information on the subject and predicate devices is summarized on the substantial equivalence chart. The substantial equivalence chart shows that the characteristics listed for the subject (OPSFD) and the three predicate devices are substantially equivalent.

Section 5 - OPSFD 510(k) Summary Statement 2014Jul21-2 Page 12 of 14

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K133809 13 of 14

Substantial Equivalence Chart: Information about the predicate devices was obtained from 510(k) summary statements and/or the 510(k) FDA Access Database

Characteristic	Subject Device(OPSFD)	Stryker® Patient SpecificPolymer Implant(K103010)	SynthesSynPOR HD PorousPolyethylene(K111323)	Polyclinic Medical Center HardTissue Replacement (HTR)Patient MatchedImplant(K924935)
Manufacturer	Oxford Performance Materials	Stryker® Howmedica Osteonics	J&J DePuy Synthes	Biomet Microfixation
RegulationNumber	878.3500 General/PlasticSurgery	878.3500 General/PlasticSurgery	878.3500 General/PlasticSurgery	878.3500 General/PlasticSurgery
RegulationName	Polytetrafluoroethylene (PTFE)with Carbon Fibers	Polytetrafluoroethylene (PTFE)with Carbon Fibers	Polytetrafluoroethylene (PTFE)with Carbon Fibers	Polytetrafluoroethylene (PTFE)with Carbon Fibers
Classification	Class II	Class II	Class II	Class II
Product Code	KKY	KKY	KKY	KKY
Intended Use	The OsteoFab® Patient SpecificFacial Device (OPSFD) isdesigned individually for eachpatient for enhancement, tocorrect trauma, and/or tocorrect defects in facial bone.The OPSFD is also designedindividually for non-load bearingenhancement of mandibularbone.	Is designed individually for eachpatient to correct traumaand/or defects in mandibular,maxillofacial, or craniofacialbone	The augmentation orreconstruction of thecraniomaxillofacial skeleton.Specific indications (SynPOR HDOcular Spheres):* Occular reconstruction* Socket preservationSpecific indications (SynPOR HDFacial Shapes):* Enhancement of the malarand chin* Correction of deficiencies ofthe malar and chin	Information not provided
Materials	OXPEKK® Polymer	Simplex P Bone Cement(PMMA)	Porous High DensityPolyethylene (HDPE)	PMMA

Section 5 - OP5FD 510(k) Summary Statement 2014Jul21-2 Page 13 of 14

Oxford Performance Materials

am land of the Royal (1) 160 11 154 11 11 850 698 9900 11 41 860 698 9976 1 www.commen

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K133809 14 of 14

Characteristic	Subject Device(OPSFD)	Stryker® Patient SpecificPolymer Implant(K103010)	SynthesSynPOR HD PorousPolyethylene(K111323)	Polyclinic Medical Center HardTissue Replacement (HTR)Patient MatchedImplant(K924935)
DimensionalSpecifications	Custom sized to each patientusing CT data	Custom sized to each patientusing CT data	Information not provided	Information not provided
Biocompatibility	ISO 10993-3, 5, 6, 10, 11, and 18compliant	Information not provided	Information not provided	Information not provided
Endotoxin	USP 85 & AAMI ST72:<2.15 EU/device (CSF contact)	AAMI ST72 LAL	Information not provided	Information not provided
Porous	No	Yes	Yes	Information not provided
Fixation	Plate and screw systems	Plate and screw systems	Information not provided	Information not provided
Curing Required	No	Yes	Information not provided	Information not provided
Sterilization	Non-sterile	Sterilized by gamma radiation	Sterilized, method not provided	Information not provided
PackagingValidation	ISTA 2A compliant	Sterile packaging validation	Information not provided	Information not provided

Section 5 - OPSFD 510(k) Summary Statement 2014Jul21-2 Page 14 of 14

Oxford Performance Materials

Oxford Performance Materials
1971 – 1981 – 1988 – 1994 – 1991 – 1962 – 1941 – 1960 – 1992 – 1992 – 1992 – 1980 – 1980 – 1980 – 1980 – 1990 – 1990 – 1990 – 199

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Image /page/14/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure. The figure is composed of three curved lines that suggest a person reaching out or embracing something.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 28, 2014

Oxford Performance Materials Incorporated Ms. Leigh Ayres Director of Scientific Regulatory Affairs P.O. Box 585 30 South Satellite Road South Windsor, Connecticut 06074

Re: K133809

Trade/Device Name: OsteoFab™ Patient Specific Facial Device Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: June 26, 2014 Received: June 30, 2014

Dear Ms. Ayres:

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 finay or subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

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 that I Dri has made a word regulations administered by other Federal agencies. You must or any I coloni surates and regisments, including, but not limited to: registration and listing (21

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Page 2 - Ms. Leigh Ayres

CFR Part 807): labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David 和Ause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Image /page/16/Picture/0 description: The image shows a logo or emblem that appears to spell out the letters "OPMI" in a stylized, geometric design. Each letter is constructed using a combination of squares, circles, triangles, and lines. The "O" is enclosed in a diamond shape, the "P" is a semi-circle, the "M" is a triangle on top of a rectangle, and the "I" is made of vertical lines.

4 - OPSFD Indications for Use Statement

510(k) Number (if known): K133809

Device Name: OsteoFab™ Patient Specific Facial Device

Indications for Use:

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 29 CFR 801 Subpart D)

Over-The-Counter Use (29 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)

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Section 4 - OPSFD Indications For Use 2014Jun12 Page 1 of 1

Oxford Parformance Materials

Oxford Portormance Motorials
30 South Sciellite Rood • South Windsor, CT 06074 USA • T: +1.860.698.9978 • www.akbridpm.com

Regulation Number and Section

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.