An OsteoFab™ Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. The OPSCD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. The OPSCD is built by a LASER sintering machine. The OPSCD is attached to native bone with commercially available cranioplasty fixation systems. The OPSCD is a non-load bearing single use device and it is non-sterilization instructions documented in the package insert have been validated.

AI/ML Overview

This document describes the performance testing conducted for the OsteoFab™ Patient Specific Cranial Device (OPSCD). The study focuses on bench testing to establish quality control specifications and demonstrate the device's material properties meet specified acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against final QC specifications derived from 23 builds, and for different thicknesses.

Summary Statistics of 23 Builds (TABLE 1):

Characteristic	Acceptance Criteria	Reported Device Performance (Mean)
Glass Transition Temperature (Tg)	154-167 °C	160.70 °C
FTIR	≥95% Match to Designated PEKK Standard	96.68% Match
Average Specific Gravity	1.25-1.31	1.28
Average Tensile Stress at Break (X-orientation) (KPSI)	≥8.77	12.04
Average Tensile Elongation @ Break (%)	≤3.6%	2.52%
Average Young's Modulus of Elasticity (KPSI)	≥262	541.61

Tensile Strength Data for Different Thicknesses (TABLE 2 - compared to 3.2 mm Release Criteria):

Characteristic	Release Criteria for 3.2 mm thickness	Reported Device Performance (Average)
1 mm thickness
Average Tensile Stress at Break (X-orientation) (KPSI)	≥8.77	10.5
Average Tensile Elongation @ Break (%)	≤3.6	2.4
Average Young's Modulus of Elasticity (KPSI)	≥262	329
2 mm thickness
Average Tensile Stress at Break (X-orientation) (KPSI)	≥8.77	10.8
Average Tensile Elongation @ Break (%)	≤3.6	2.4
Average Young's Modulus of Elasticity (KPSI)	≥262	409
4 mm thickness
Average Tensile Stress at Break (X-orientation) (KPSI)	≥8.77	11.6
Average Tensile Elongation @ Break (%)	≤3.6	2.4
Average Young's Modulus of Elasticity (KPSI)	≥262	490

Through Hole Size and Spacing Measurements (TABLE 3 & 4):

Characteristic	Nominal Value with Tolerance	Reported Device Performance (Average)
5 mm Through Hole (Diameter)	5.00 (4.50 – 5.50) mm	4.74 mm
2 mm Through Hole (Diameter)	2.00 (1.50 - 2.50) mm	1.92 mm
5 mm Spacing between Through Holes	5.00 (4.50 - 5.50) mm	4.81 mm
2 mm Spacing between Through Holes	2.00 (1.50 - 2.50) mm	1.79 mm

2. Sample Size Used for the Test Set and the Data Provenance

For final QC specifications (TABLE 1): The test set was derived from 23 builds. No further information on the specific number of individual test specimens per build for each parameter is provided, but for tensile strength testing, it's mentioned that OPSCD test specimens from the 23 builds were 3.2 mm thick.
For minimum thickness determination (TABLE 2): Three sets of 5 specimens each were used for 1 mm, 2 mm, and 4 mm thicknesses (total 15 specimens).
For through-hole measurements (TABLE 3 & 4): 10 specimens for each through-hole size (5 mm and 2 mm) were measured for both diameter and spacing (total 20 measurements for diameter, 20 for spacing across two categories).
Data Provenance: The data appears to be from retrospective bench testing conducted internally by Oxford Performance Materials, LLC. There is no information on the country of origin of the data beyond the manufacturer's location in South Windsor, CT, USA.

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

This study involves bench testing for material properties and physical specifications. Therefore, the "ground truth" is established by standardized laboratory testing procedures and predefined acceptance criteria, not by expert human graders. No experts were used in this context to establish a "ground truth" for interpretations as would be in a diagnostic imaging study.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing, there is no human adjudication process involved in reviewing the results; the results are quantitative measurements compared against predetermined numerical acceptance criteria.

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 is a bench testing study for a medical device's physical and material properties, not a study evaluating human reader performance with or without AI assistance in a clinical setting.

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

Not applicable. This is not an AI algorithm study; it is hardware bench testing.

7. The Type of Ground Truth Used

The ground truth used for this study is based on predefined engineering specifications and material property standards. These specifications are derived from statistical analysis (mean +/- 3 standard deviations for some parameters, or a percentage match for others) established from the initial 23 builds, and industry standards for material characteristics. For the through-hole measurements, the ground truth is the nominal design value with a specified tolerance.

8. The Sample Size for the Training Set

For establishing final QC specifications (TABLE 1): The "training set" for these specifications could be considered the 23 builds from which the mean and standard deviation values were calculated to define the acceptance criteria.

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

The "ground truth" (i.e., the acceptance criteria and reference values) for the training set (the 23 builds) was established through statistical analysis of the measured outcomes from these 23 builds. For parameters like Tg, Specific Gravity, Tensile Stress, Elongation, and Young's Modulus, the acceptance criteria were defined as "Mean +/- 3SD", "Mean - 3SD", or "Mean + 3SD" based on the data from these 23 builds. For FTIR, it was a "≥95% Match to a Designated PEKK Standard". This indicates an internal reference standard was used.

Summary

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K121818
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5 - 5 1 0 (k) Summary Statement as Required by Title 21 CFR 807.92

FEB 7 2013

510(k) Submitter: Oxford Performance Materials, LLC 30 South Satellite Road South Windsor, CT 06074 USA 1-860-698-9300

Contact Person: Leigh Ayres, Director of Scientific & Regulatory Affairs Date of 510(k) summary preparation: December 18, 2012 Proprietary Name: OsteoFab™ Patient Specific Cranial Device Common or Usual Name: Patient Specific Cranial Implant Classification: Title 21 CFR 882.5330; Preformed Non-Alterable Cranioplasty Plate; Class II Panel: Neurology Product Code: GXN Predicate Devices: Kelyniam Custom Skull Implant (K103582), Synthes Patient Specific Cranial Implant (K053199), Osteo-Symbionics Patient Specific Cranial Implant (K072601), MedCAD AccuShape PEEK Patient Specific Implant (K110684), and Osteo-Symbionics Patient Specific

Description of the Device

Cranial Implant (K121102)

Intended Use Statement

The OsteoFab™ Patient Specific Cranial Device (OPSCD) intended for the replacement of bony voids in the cranial skeleton.

Endotoxicity

Non-sterillized OsteoFab™ Patient Specific Cranial Device (OPSCD) test specimens were subjected to a Limulus Amebocyte Lysate (LAL) assay according to USP 85 and the results of the testing showed that bacterial endotoxin levels were lower than the detection limit of 2.15 EU/device.

Section 5 OPSCD 510(k) Summary 2012Dec18 Page 1 of 5

30 South South Windsor, CT 06074 USA • T: +1.860.698.9300 • F: +1.860.698.9978 • www.oxfordpm.com

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Biocompatibility

Biocompatibility tests were selected according to the FDA guidance document: "Use of International Standard 150-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (1995) and the test results obtained from test specimens were found to be within acceptance criteria described in the standards.

Performance Testing - Bench Testing

The test suite for the final quality control (QC) testing of the OsteoFab™ Patient Specific Cranial Device (OPSCD) includes glass transition temperature (Tg), Fourier transform infrared spectroscopy (FTIR), specific gravity, and tensile strength.

The final QC specifications for those tests were determined from 23 builds. TABLE 1 shows the mean, standard deviation, the standard deviation multiplied by three, the acceptance criteria, and the formula for the acceptance criteria.

	Tg(20°C/min)	FTIR	AverageSpecificGravity	AverageTensileStress atBreak (X-orientation)(KPSI)	AverageTensileElongation@ Break(%)	AverageYoung'sModulus ofElasticity(KPSI)
mean	160.70	96.68	1.28	12.04	2.52	541.61
SDEV	2.10	0.73	0.01	1.10	0.35	93.89
3SD	6.30	2.19	0.03	3.27	1.05	279
AcceptanceCriteria	154-167	≥95% Match	1.25-1.31	≥8.77	≤3.6%	≥262
Formula fortheAcceptanceCriteria	Mean +/-3SD	≥95% Matchto aDesignatedPEKKStandard	Mean +/-3SD	Mean - 3SD	Mean +3SD	Mean - 3SD

TABLE 1: Summary Statistics of 23 Builds

The OPSCD test specimens from the 23 builds which were subjected to tensile strength testing were 3.2 mm thick. In order to determine the minimum thickness for an OPSCD..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 2).

Section 5 OPSCD 510(k) Summary 2012Dec18 Page 2 of 5

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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. Based on the measurements obtained, the minimum thickness of an OPSCD 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	$ \ge 8.77 $	$ \le 3.6 $	$ \ge 262 $

TARIE 7. Summ and Statistics of the 1 7 and 4 mm Thick Tost S

Test specimens were also built to determine the range of pore (through hole) 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 is 2 mm to 5 mm and the minimum spacing of through holes is 2 mm. TABLE 3 and TABLE 4 show the average of the through hole size measurements and the average of the spacing between through hole measurements, respectively.

TABLE 3: Vernier Caliper Measurements of the Diameter of Through Holes

	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 4: 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)

്Section 5 OPSCD 510(k) Summary 2012Dec18 Page 3 of 5

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K121318
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Substantial Equivalence Discussion

The OsteoFab™ Patient Specific Cranial Device (OPSCD) is substantially equivalent to five other preformed nonalterable cranioplasty plates: the Kelyniam custom Skull Implant, the Synthes Patient Specific Cranial Implant, the Osteo-Symbionics Patient Specific Cranial Implant, the MedCAD AccuShape PEEK Patient Specific Implant, and the Osteo-Symbionics Patient Specific Cranial Implant.

The intended use statement for the OPSCD is within the scope of application for the five predicate devices. The intended use statements of the Synthes and Osteo-Symbionics devices apply to cranial and craniofacial bone. The intended use statement of the OPSCD is limited to cranial skeleton.

All five predicate devices are fabricated from polymers, each is custom sized to the patient, and they are sold non-sterile. The substantial equivalence Information on the subject and predicate devices is summarized on the substantial equivalence matrix (TABLE 5). The substantial equivalence matrix shows that the characteristics listed for the subject (OPSCD) and the five predicate devices are substantially equivalent.

Section 5 OPSCD 510(k) Summary 2012Dec18 Page 4 of 5

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TABLE 5: Substantial Equivalence Matrix

Characteristic	OsteoFab™Patient SpecificCranial Device(Subject Device)	KelyniamCustom SkullImplant(K103582)	SynthesPatient SpecificCranial Implant(K053199)	Osteo-SymbionicsPatient SpecificCranial Implant(K072601)	MedCADAccuShape PEEKPatient SpecificImplant(K110684)	Osteo-SymbionicsPatient SpecificCranial Implant(K121102)
Intended Use	Replace bonyvoids in thecranial skeleton	Replace bonyvoids in thecranial skeleton	Replace bonyvoids in thecranialcraniofacialskeleton	Corrects defectsin craniofacialbone	Correctdefects/replacebony voids inthe cranialskeleton	Designedindividually foreach patient tocorrect defectsin cranial bone
Materials	ΟΧΡΕΚΚ	PEEK-OPTIMALT1	PEEK Optima-LT1	PolymethylMethacrylate(PMMA)	PEEK	PEEK
TechnicalSpecifications	Custom sized toeach patientutilizingCT data	Custom sized toeach patientutilizingCT data	Custom sized toeach patient	Plate - customsized to eachpatient	Custom sized toeach patientutilizing CT data	Manufacturedone at a time tocustom-orderbased upon thepatient's CT scan
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile	Non-sterile

Section 5 OPSCD 510(k) Summary 2012Dec18 Page 5 of 5

Oxford Performance Materials

. . . . . . . . . . . .

0 South Solellie Rood • South Windsor, CT 06074 USA • T: +1.860.698.9978 • www.oxfordpm.com

K121818

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Image /page/5/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 tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top of the circle.

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

FEB 26 2013

Oxford Performance Materials % Ms. Leigh Avres Director of Scientific and Regulatory Affairs 30 South Satellite Road South Windsor, CT 06074

Re: K121818

Trade/Device Name: OsteoFabTM Patient Specific Cranial Device Regulation Number: 21 CFR 886.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: December 18, 2012 Received: December 28, 2012

Dear Ms. Ayres:

This letter corrects our substantially equivalent letter of February 7, 2013.

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. Leigh Ayres

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4 - Indications for Use Statement

510{k) Number (if known):

Device Name: OsteoFab™ Patient Specific Cranial Device

Indication for Use:

The OsteoFab™ Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton.

Prescription Use V AND/OR (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)

(Division Sign-Off)

Division of Neurological and Physical
Medicine Devices
510(k) Number K,121818

Section 4 Page 1 of 1

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).