The OsteoFab Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.

Device Description

An OsteoFab® Patient Specific Cranial Device (OPSCD) is built individually for each patient to correct defects in cranial bone. OPSCDs are constructed with the use of the patient's CT scan and computer aided design is used to determine the geometry of each implant. OPSCDs are built by laser sintering polyetherketone (PEKK) polymer in Oxford Performance Materials' OsteoFab® process. OPSCDs are attached to native bone with commercially available cranioplasty fixation systems and are a non-load bearing, single use device. OPSCDs are provided non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OsteoFab Patient Specific Cranial Device (K180064), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Meeting existing product release criteria (for OPSCDs designed to fit pre-planned virtual defects).	All acceptance criteria were met, showing that OPSCDs used in single-stage cranial surgeries can successfully fill a defect that did not exist prior to the surgical procedure. OPSCDs were designed to fit pre-planned virtual defects and function as intended.
Successful shipment without damage to the devices.	All acceptance criteria were met.
Successful fixation of the implants onto the skull models.	All acceptance criteria were met.
Satisfactory fit on skull models.	All acceptance criteria were met.
Verification of the process of using OPSCDs for single-stage cranioplasty procedures (where the defect is not present at the time of the CT scan).	The End-to-End Simulation test successfully verified this process. Implants were designed to K121818 specifications, manufactured with the same process, inspected, shipped, and fit tested on skull models. Fit testing mimicked typical single-stage cranioplasties using commercially available marking guides.
The OPSCD is considered as safe and as effective as the predicate device and performs as well as the marketed predicate device.	Based on the results of the performance bench testing, this conclusion was reached.

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

Sample Size for Test Set: "Worst-case, representative cranial cases were selected for end-to-end simulation testing." The document does not specify a numerical sample size for the test set (number of cases/implants tested).
Data Provenance: The study was a "bench test" simulation. The specific country of origin for the "worst-case, representative cranial cases" or skull models is not mentioned. It is a prospective test, as it was conducted to demonstrate the device's performance for this specific 510(k) submission.

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

The document does not mention the use of experts to establish ground truth for the bench testing. The "acceptance criteria included meeting existing product release criteria, successful shipment... successful fixation... and satisfactory fit." This suggests a set of objective, measurable criteria rather than expert consensus on subjective aspects.

4. Adjudication method for the test set

Adjudication methods like 2+1 or 3+1 (typically used for expert reviews) are not applicable here, as expert ground truth establishment is not described for the bench test. The acceptance was based on meeting predefined objective 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

No, an MRMC comparative effectiveness study involving human readers or AI assistance was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable to the OsteoFab Patient Specific Cranial Device. It is a physical medical device, not an algorithm. The "design process" does use computer-aided design, but the "performance" discussed is related to the physical fit and functionality of the implant, not an algorithm's classification accuracy.

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

The ground truth for the bench testing was based on pre-defined, objective engineering and fit criteria ("existing product release criteria, successful shipment without damage, successful fixation, and satisfactory fit"). It's a form of objective performance criteria met in a simulated environment, rather than clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

The concept of a "training set" is not applicable in the context of this device's performance testing. This device is a custom-manufactured implant based on patient-specific CT data and a cleared manufacturing process, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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July 27, 2018

Oxford Performance Materials, Inc. M. Beth Pashko Quality Director 30 South Satellite Road South Windsor, Connecticut 06074

Re: K180064

Trade/Device Name: OsteoFab Patient Specific Cranial Device Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: June 29, 2018 Received: July 2, 2018

Dear Ms. Pashko:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Valerie A. Flournoy -S

Carlos L. Peña, PhD, MS For Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180064

Device Name OsteoFab Patient Specific Cranial Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [As required by 21 CFR 807.92]

I. Submitter
510(k) Owner:	Oxford Performance Materials, Inc.
	30 South Satellite Road
	South Windsor, CT 06074 USA
	Phone: +1.860.698.9300
	Fax: +1.860.698.9978
Submitter/Contact:	M. Beth Pashko
	Quality Director
	Oxford Performance Materials, Inc.
	30 South Satellite Road
	South Windsor, CT 06074 USA
	Phone: +1.860.698.9300
Date Prepared:	June 29, 2018
II. Device

Proprietary Name:	OsteoFab® Patient Specific Cranial Device
Common or Usual Name:	Patient Specific Cranial Implant
Classification:	21 CFR 882.5330; Preformed non-alterable cranioplasty plate
Regulatory Class:	Class II
Product Code:	GXN
Review Panel:	Neurology

III. Predicate Device

Predicate Device:

Oxford Performance Materials, Inc. OsteoFab® Patient Specific Cranial Device (K121818)

IV. Device Description

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Indications for Use

The OsteoFab® Patient Specific Cranial Device (OPSCD) is intended for the replacement of bony voids in the cranial skeleton. OPSCDs may be used to fit pre-planned virtual defects in the instance of single stage cranioplasty procedures.

V. Comparison of Technological Characteristics with the Predicate Device

Principle of Operation

The basic operational principle of the OPSCD remains the same as the predicate: the operating principle of the OPSCD is to replace bony voids in the cranial skeleton.

Technological Characteristics

New performance data was required to ensure that OPSCDs can be used successfully in preplanned defects in addition to existing cranial bone defects. The technological characteristics remain the same and are summarized below.

Same operating principle: to replace bony voids in the cranial skeleton |
Same material: there is no change to the implant material ।
Same manufacturing process: laser sintering of PEKK polymer ।
Same sterilization method: there is no change in the implant sterilization method ।
। Similar design process: there is no change to the implant design process. Surgeons may now provide single-stage design inputs for the scope of the implant reconstruction boundary
Same mode of fixation: commercially available cranioplasty fixation systems --

VI. Performance Data

The modifications described in this submission include a clarification to the device Warnings based on the prescribed Indications for Use. There are no changes to the device specifications, manufacturing process, or operating principle of the OPSCD. The following performance data were provided in support of the substantial equivalence determination based on the risk analysis that was performed.

Performance Bench Testing

The following performance bench test was completed:

OPSCD 510(k) Summary Page 2 of 3

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Test	Test Method Summary	Results
End-to-End SimulationReport for OPSCD for SingleStage Surgery	Worst-case, representativecranial cases were selectedfor end-to-end simulationtesting.	All acceptance criteria weremet, showing that OPSCDsused in single stage cranialsurgeries can successfully filla defect that did not existprior to the surgicalprocedure, that is, OPSCDsmay be designed to fit pre-planned virtual defects andfunction as intended.
The purpose of this test wasto verify the process of usingOPSCDs for single stagecranioplasty procedures, thatis, where the defect is notpresent at the time of the CTscan.	Implants were designed tothe specifications cleared inK121818, manufacturedusing the same process,inspected, shipped, and fittested on skull models. Fittesting was conducted usingcommercially availablemarking guides, as is typicalin single stage cranioplasties.	Based on these results, theOPSCD is considered as safeand as effective as thepredicate device andperforms as well as themarketed predicate device.
	Acceptance criteria includedmeeting existing productrelease criteria, successfulshipment without damage tothe devices, successfulfixation of the implants ontothe skull models, andsatisfactory fit.

Animal Testing

Animal testing was not required as a basis for substantial equivalence.

Clinical Testing

Clinical testing was not required as a basis for substantial equivalence.

VII. Substantial Equivalence Conclusion

Enabling surgeon design inputs for single stage procedures does not impact the safety or effectiveness of the device per the results of the non-clinical data. The summarized performance testing supports that the OsteoFab® Patient Specific Cranial Device is as safe and as effective as the predicate device and that it performs as well as the marketed predicate device in the prescribed indications. The technological principles of the subject device are unchanged and are substantially equivalent to the predicate device, according to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein.

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).