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The OsteoFab® Suture Anchors are intended to be used for the fixation/reattachment of soft tissue to bone in the shoulder, knee, hand and wrist, elbow, and foot and ankle in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability Repair.

Knee: Extra Capsular Ligament Repair, Patellar Realignment and Tendon Repairs, and Illiotibial Band Tenodesis.

Hand and Wrist: Ulnar or Lateral Collateral Ligament Reconstruction, Collateral Ligament Reconstruction or Repair.

Elbow: Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair, Biceps Tendon Repair.

Foot and Ankle: Hallux Valgus Repairs, Medial or Lateral Instability Repairs and Reconstructions, Achilles Tendon Repairs and Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs and Reconstructions, Bunionectomy.

The OsteoFab® Suture Anchor is a single procedure suture anchor device for the reattachment of soft tissue to bone in shoulder, knee, hand and wrist, elbow, and foot and ankle procedures. This reattachment of damaged soft tissue is achieved with suture that is threaded through an anchor which is fixated in bone via interference fit between the anchor and bone. The anchor is mounted on a custom inserter and threaded with recommended suture before deployment. The OsteoFab® Suture Anchors are manufactured from polyetherketone (PEKK) polymer in Oxford Performance Materials, Inc.'s proprietary additive manufacturing process. The OsteoFab® Suture Anchors are available in three sizes (4.5, 5.5, ad 6.5mm) and are provided non-sterile.

The provided text describes a medical device (OsteoFab® Suture Anchors) and its performance data submitted to the FDA for 510(k) clearance. This means the primary focus is on establishing substantial equivalence to a predicate device, rather than proving novel efficacy through clinical trials. Therefore, much of the information typically found in an AI/Software as a Medical Device (SaMD) study (like detailed test set specifics, expert qualifications for ground truth, MRMC studies, or training set details) is not present here as it is not applicable to a device like a physical suture anchor.

However, I can extract the relevant information from the document regarding acceptance criteria and the studies performed to demonstrate substantial equivalence.

Acceptance Criteria and Study for OsteoFab® Suture Anchors

The OsteoFab® Suture Anchors are physical medical devices, not an AI/SaMD. As such, the "acceptance criteria" and "study" are focused on mechanical performance, biocompatibility, and substantial equivalence to a legally marketed predicate device, rather than diagnostic accuracy or human reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

The overarching acceptance criterion for the 510(k) submission is to demonstrate substantial equivalence to the predicate device (K122314 Cayenne Quattro Link Knotless Anchors) in terms of safety and effectiveness. The performance data listed above were presented to support this conclusion.

2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (e.g., number of anchors tested) for the mechanical bench tests or the biocompatibility tests. Product safety and performance tests are typically conducted on a representative sample of finished devices according to validated protocols.

• Data Provenance: The studies were internal company tests ("Performance Bench Testing," "Biocompatibility Testing"). No information is provided regarding the specific geographical origin of data beyond the company's US location.
• Retrospective/Prospective: These are laboratory and bench tests, not clinical studies, so the terms "retrospective" or "prospective" are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not directly applicable to the evaluation of a physical medical device like a suture anchor. The "ground truth" for mechanical and biocompatibility testing is established through standardized engineering and biological test methods, often specified by international standards (e.g., ISO standards for biocompatibility). The results are objectively measured (e.g., force, displacement, cellular response) rather than requiring expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective physical and biological tests, not evaluations requiring human adjudication of subjective data.

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 device is a physical suture anchor, not an AI/SaMD designed to assist human readers or provide diagnostic information.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical suture anchor, not an AI algorithm.

7. The Type of Ground Truth Used
The "ground truth" for this device consists of:

• Mechanical performance standards: Established engineering principles and, likely, comparison against the predicate device's known mechanical properties. The goal is to demonstrate that the new device meets or exceeds appropriate strength and durability.
• Biocompatibility standards: International standards (e.g., ISO 10993 series) for evaluating biological response to medical devices.
• Predicate device performance: The performance of the legally marketed predicate device (K122314 Cayenne Quattro Link Knotless Anchors) serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established
Not applicable. As a physical medical device, there is no "training set" or "ground truth" in the AI/ML sense.

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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.

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.

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

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.

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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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SpineFab® Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e. fracture). The VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems.

The SpineFab® VBR implant is a non-custom implant. The SpineFab® VBR Implants consist of 48 different variations and each one of six different configurations (Small Parallel, Medium Parallel, Large Parallel, Small Lordotic, Medium Lordotic, and Large Lordotic) with the only difference on each configuration being the height. This device is manufactured using polyetherketoneketone (PEKK) polymer using additive manufacturing and contains tantalum radiographic markers.

The implants have an open shaft to allow for the placement of allograft or autograft. The implants have several other features:

• Notches that are an aid to implant insertion,
• Tantalum markers which allow for easy radiographic visualization, and
• Teeth-like structures meant to engage the vertebral endplates for stabilization in vivo.

SpineFab® Vertebral Body Replacement (VBR) System 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 validated.

This document describes the premarket notification (510(k)) for the SpineFab® Vertebral Body Replacement (VBR) System. It focuses on demonstrating the device's substantial equivalence to existing predicate devices, primarily through bench testing.

Here's an analysis of the acceptance criteria and study detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of quantified acceptance criteria with specific performance values for the SpineFab® VBR System. Instead, it states that performance testing was conducted according to recognized ASTM and ISO standards, and the results "were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards" for biocompatibility and that mechanical testing was performed according to ASTM standards for compression, torsion, subsidence, and expulsion.

For the purpose of this analysis, we can infer the acceptance criteria are adherence to these established standards.

• ISO 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-6: Tests for local effects after implantation
• ISO 10993-10: Tests for irritation and skin sensitization
• ISO 10993-11: Tests for systemic toxicity
• ISO 10993-18: Chemical characterization of materials | 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. |
  | Mechanical Performance (Compression, Torsion, Subsidence, Expulsion) | Testing performed according to:
• ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices"
• ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression"
• ASTM draft F-04.25.02.02: Static Expulsion (The specific acceptance limits from these standards are not detailed in the document but are implied to be met) | Mechanical testing evaluations were substantially equivalent to predicate devices, having been evaluated according to ASTM standards for static and dynamic axial compression bending, static and dynamic torsion, static subsidence, and static expulsion. |
  | Sterilization | 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." (Implies meeting sterility assurance levels outlined in this standard.) | The device is shipped non-sterile, and the sterilization recommendations in the IFU are according to ANSI/AAMI ST79 and "have been validated." |

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

• Sample Size for Mechanical Testing: The document mentions a specific test specimen design (15x12x50 mm) considered the "worst case design" for compression, torsion, subsidence, and expulsion testing. However, the number of specimens tested ("sample size") for each mechanical test is not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. Given that this is bench testing, "provenance" typically refers to the testing laboratory and design/manufacturing controls rather than patient data.

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

This information is not applicable in the context of this 510(k) submission. The document describes bench testing of a physical device, not a diagnostic or AI device that relies on expert interpretation to establish ground truth for a test set. The "truth" for mechanical properties is determined by the physical outcome of the tests against engineering specifications and validated standards.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing involves physical measurements against engineering standards and not human interpretation of complex data (like medical images), there is no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device submission. This study type is typically used for diagnostic devices (e.g., AI algorithms for image interpretation) to show how an AI system impacts human reader performance. The SpineFab® VBR System is an implantable surgical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was not performed, nor is it relevant to this device. This concept applies to AI algorithms. The SpineFab® VBR System is a physical medical device.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is established by engineering and material science standards and specifications. Specifically:

• Biocompatibility: Adherence to established ISO 10993 series standards, which define acceptable biological responses.
• Mechanical Performance: Adherence to established ASTM standards (F2077, F2267, and a draft F-04.25.02.02), which define acceptable mechanical properties and testing methodologies for intervertebral body fusion devices.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device. The SpineFab® VBR System is a physical implant, not a software algorithm that undergoes machine learning training.

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

This information is not applicable. As there is no training set for a software algorithm, the concept of establishing ground truth for it does not apply here.

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

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.

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):

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

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

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.

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