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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.

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.

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.

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.

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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.

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.

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.

• 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.

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