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

HTR-PEKK is a custom implant and the shapes and sizes vary within the following specifications: (1) maximum diameter is 20cm (2) minimum thickness is 1mm (2mm in areas of fixation), (3) maximum thickness is 20mm and the maximum thickness for holes is 10mm, (4) maximum open density is 25%, (5) minimum as designed through-hole diameter is 3mm, (6) maximum as designed though-hole size must meet these specifications (7) minimum distance from the edge of an as designed through-hole (for a cluster of perfusion-holes) to the edge of a device is 15mm, (8) minimum distance from the center of an as designed dimple to the edge for plating is 2.5mm for a 1.5mm diameter screw, (9) minimum distance from the center of an as designed dimple to the edge for lagging is 2.5mm for a 1.5mm diameter screw, (10) minimum distance between two lag holes is 3.25mm for a 1.5mm diameter screw, (11) minimum distance from the center of an as designed dimple to the edge for lagging is 3.75mm for a 2mm diameter screw, and (12) minimum distance between two lag holes is 3.75mm for a 2mm diameter screw.

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. The OPSFD is built by a LASER sintering machine. The OPSFD is attached to native bone with commercially available fixation systems. The OPSFD is a non-load bearing single use device and it is shipped non-sterile.

AI/ML Overview

The provided text describes a 510(k) submission for the "OsteoFab Patient Specific Facial Device" (OPSFD), which is an update to an existing device (K133809). This document is an FDA letter and a 510(k) summary, primarily focused on modifications to device specifications and labeling, rather than a comprehensive, standalone clinical study proving the device's overall effectiveness or safety from scratch.

Therefore, the information regarding acceptance criteria and a study proving those criteria is limited to changes related to implant thickness and fixation mechanisms, as these were the only areas where "new non-clinical performance data" was deemed necessary based on risk analysis.

Here's an attempt to answer your questions based on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly define acceptance criteria as pass/fail values for the new performance data. Instead, it states that "The data obtained was proof of performance" for the changes. The changes themselves relate to specific dimensions and fixation guidelines.

Acceptance Criteria (Implied from Modifications)	Reported Device Performance (Implied from Text)
Implant Minimum Thickness: Amended to 1mm (2mm in areas of fixation).	New non-clinical performance data was submitted in the Special 510(k) for implant thickness to verify and validate the changes. The data obtained was proof of performance. (No specific values provided, but the verification supports the amended specification.)
Implant Maximum Thickness: Increased to 20mm (10mm for holes).	New non-clinical performance data was submitted in the Special 510(k) for implant thickness to verify and validate the changes. The data obtained was proof of performance. (No specific values provided, but the verification supports the increased specification.)
Screw Fixation Placement: Screws for plating or lagging must be placed only in areas of an implant with a minimum thickness of 2mm.	New non-clinical performance data was submitted in the Special 510(k) for fixation to verify and validate the changes. The data obtained was proof of performance. (No specific values provided, but the verification supports the new guideline.)
Surgeon Contouring Guidance: Special care needed if contouring is required in areas of fixation regarding implant thickness and distance to the edge.	The warnings regarding fixation and contouring were derived from the results of the performance testing. New non-clinical performance data for fixation was submitted to verify and validate these changes. (No specific values provided, but the testing supports the need for this warning.)
Through-hole Specifications: Clarification of "as designed" vs. "as built" for min/max through-hole diameter; qualification for 15mm edge distance for cluster of perfusion-holes; defined edge and center-to-center distances for plating/lagging dimples.	"New performance data was not required for changing the specifications from 'as built' to 'as designed' because the change was a correction." "New performance data was not needed for the change to the maximum though-hole specification because it was a correction." "Performance data was not required regarding the qualifier that was added for the 15mm edge specification... provided clarity to the device description to insure safer or more effective use." (These changes were considered clarifications or corrections, not requiring new performance data.)

Note: The document explicitly states "New performance data was not required" for some changes, indicating that for those, the previous data for the predicate device was considered sufficient or the change was purely administrative/clarifying. For the thickness and fixation changes, new non-clinical performance data was required and submitted, and deemed "proof of performance."

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

Sample Size for Test Set: Not specified. The text only refers to "new non-clinical performance data" and "performance testing" related to changes in implant thickness and fixation. It does not provide details on the number of samples or tests conducted.
Data Provenance: The study was "new non-clinical performance data" suggesting it was generated in a lab setting rather than from patient data. The origin is implied to be from Oxford Performance Materials, Inc. (South Windsor, CT, USA). It is a prospective test in the sense that it was specifically conducted to address the changes in device specifications.

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

Not applicable / Not specified. This was a non-clinical performance study, meaning it likely involved engineering tests (e.g., mechanical strength, durability simulations) rather than expert review of clinical cases. Therefore, the concept of "ground truth established by experts" in a clinical diagnostic sense does not apply here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not specified. Given it was a non-clinical performance study, an adjudication method for reconciling expert opinions on clinical cases is not relevant. The verification and validation would have involved engineering and quality assurance standards.

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 was a submission for a patient-specific physical implant, not an AI diagnostic or assistance tool. Therefore, an MRMC study or AI-related effectiveness study was not conducted or mentioned.

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

No. This device is a physical implant, not an algorithm. The design process does involve "computer aided design" based on patient CT imaging data, but there's no mention of a standalone algorithm performance study in the context of typical AI device evaluations. The "device" is the final physical product.

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

The "ground truth" for the non-clinical performance data would be based on engineering standards, material science properties, and mechanical test results. For example, the ground truth for "minimum thickness for screws" would be whether a sample implant of that thickness can reliably hold a screw under specified forces without failure, as determined by laboratory testing and industry standards for implant fixation. It's not clinical "ground truth" like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable / Not specified. As this is not an AI/machine learning device, there is no "training set." The device is designed for individual patients based on their specific CT data.

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

Not applicable / Not specified. No training set was used.

Summary

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

July 20, 2016

Oxford Performance Materials, Inc. Ms. Leigh Ayres SRA Director 30 S. Satellite Road South Windsor, CT 06074

Re: K161052

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 22, 2016 Received: June 23, 2016

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 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 801); medical device reporting (reporting of medical

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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/Resourcesfor You/Industry/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 Krause -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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Indications for Use

510(k) Number (if known) K161052

Device Name

OsteoFab® Patient Specific Facial Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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OPSFD 510(k) Summary as Required by Title 21 CFR 807.92

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 12, 2016 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 Device: Oxford Performance Materials, Inc. OsteoFab® Patient Specific Facial Device (K133809)

Description of the Device

Note: number 7 regarding as designed holes was changed to add a qualifier based on the context of that configuration of through-holes.

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Intended Use Statement

Description of the Modifications

The description in the labeling is the same as the description that was submitted in K133809 except the following changes were made:

1. Implant minimum thickness was amended (number 2).
1. Implant maximum thickness was increased (number 3).
1. The minimum through-hole diameter was defined in terms of an as designed instead of an as built specification (number 5).
1. The maximum through-hole diameter was defined in terms of an as designed instead of an as built specification that must meet all of the specifications in the · · device description section (number 6).
ട. A qualification statement for the minimum edge distance regarding a cluster of perfusion-holes was added (number 7).
1. The minimum as designed edge distance for plating was added (number 8).
1. The minimum as designed edge and through-hole center to center distances for lagging were added (numbers 9, 10, 11, and 12).

The following additions were made to the Warnings section of the IFU for this Special 510(k):

1. Screw fixation for plating or lagging should be placed only in areas of an implant that has minimum thickness of a 2mm (number 1).
1. The Surgeon should take special care if contouring is needed in areas where there is going to be fixation regarding implant thickness and distance to the edge (number 5).

The warnings regarding fixation and contouring were derived from the results of the performance testing.

Performance Data and Risk Analysis

New performance data was not required for changing the specifications from "as built" to "as designed" because the change was a correction. New performance data was not needed for

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the change to the maximum though-hole specification because it was a correction - the 5mm test specification had been included in the K133809 evaluation as an aid to determine the minimum though-hole size.

New performance data was not required regarding the qualifier that was added for the 15mm edge specification. Performance data was not required because the qualifying statement regarding a cluster of through-holes provided clarity to the device description to insure safer or more effective use. The statement about the cluster of though-holes provided clarity because the intent of that specification is to provide a margin of safety for the location of though-holes when they could be near to the location of dimples that are utilized for fixation procedures.

The changes in the package insert for implant thickness and fixation (plating and lagging) required new non-clinical performance data based on the results obtained from risk analysis. Risks were calculated according to the severity, probability, and detectability of failure modes.

The new performance data was submitted in the Special 510(k) for implant thickness and fixation in order to verify and validate the changes to the package insert. The data obtained was proof of performance.

Substantial Equivalence Conclusion

The modifications to the description and warnings of the labeling for the subject device are substantially equivalent to the predicate device.

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.