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The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The FITme Customized Silicone Implant is a patient-specific medical device intended for augmentation, reconstructive and cosmetic surgery of facial region, specifically the nasal contour, the malar cheek contour, and chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant, FITme Customized Silicone Implant, is made of implant grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computed Tomography (CT) scan) is translated into a digital model of the patient's skull using the software, Mimics by Materialise. At the recommendation of the surgeon, the Mimics is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or to create a digital implant model as an STL file.

KEOSAN TRADING Co. manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by KEOSAN TRADING Co., using plaster molds or 3D-printed molds as appropriate. The FITme Customized Silicone Implant is manufactured from the customized molds and provided to the surgeon, non-sterile.

The provided text is a 510(k) premarket notification for a medical device (FITme Customized Silicone Implant). It asserts substantial equivalence to a predicate device, but does not describe acceptance criteria, a study proving device performance against those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot provide the requested table and information based on the given document. The document describes a traditional medical device (silicone implant) and its manufacturing process, not an AI or software algorithm.

To answer your request, a document detailing the validation of an AI/software as a medical device (SaMD) or an AI-powered medical device would be required. This would typically include performance metrics like sensitivity, specificity, accuracy, and confidence intervals, along with details on test sets, ground truth establishment, and expert involvement.

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Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.

Longeviti PorousFit implants are single-use, high density polyethylene (HDPE) for permanent implantation to restore the natural contour of the craniofacial skeleton. Devices are molded into various dimensions and shapes based on the area of the craniofacial skeleton requiring reconstruction and/or augmentation. PorousFit implants are provided sterile using ethylene oxide (EO).

The provided documents do not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of AI/ML-based medical devices or diagnostic tools.

The document is a 510(k) premarket notification for the Longeviti PorousFit implant, which is a physical medical device (an implant for craniofacial reconstruction). The FDA letter and the 510(k) summary pertain to demonstrating substantial equivalence to a predicate device, not to demonstrating performance against specific accuracy metrics for an AI algorithm.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not applicable to an implant undergoing a 510(k) for substantial equivalence. The "performance" for such a device is demonstrated through biocompatibility, mechanical testing, and manufacturing consistency, not diagnostic accuracy.
2. Sample sizes used for the test set and data provenance: No "test set" in the context of an AI/ML algorithm exists. Performance is based on material properties and manufacturing processes.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for an implant is its physical and biological properties, not a diagnostic read.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with AI assistance.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI model evaluation. The "ground truth" for the implant itself relates to its physical and chemical properties and biological response.
8. The sample size for the training set: Not applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

What the document does describe regarding "testing" for this implant is:

• Summary of Testing: "Testing completed by Matrix Surgical USA for their OmniPore implants are applicable to the Longeviti PorousFit implants. This includes biocompatibility evaluations (Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study), mechanical evaluations, impact testing, purity testing per USP, and porosity testing."

This type of testing is standard for physical implants to ensure their safety and effectiveness, and the applicant is leveraging testing done for their predicate device due to identical materials and manufacturing processes.

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The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.

The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

This document is about the FDA 510(k) clearance for Implantech Associates Inc.'s Customized Contour Implant. It is a premarket notification, and as such, it does not typically contain detailed studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, the information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI/ML performance, human readers, sample sizes for test/training sets, and ground truth establishment, is not applicable to this document.

The document primarily focuses on:

• Device Description: A patient-matched device made of medical-grade silicone elastomer for augmentation, reconstructive, and cosmetic surgery (facial, gluteal, calf, pectoralis implants).
• Predicate Device Identification: Listing several previously cleared Implantech implants (K191130, K052504, K052505, K952708) with similar materials and intended uses.
• Non-Clinical Testing: The only "studies" mentioned are non-clinical tests to demonstrate safety based on industry standards, including:
  • Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
  • Packaging validation per ISO 11607
  • Shelf life validation with accelerated and real-time aging studies
  • Cytotoxicity testing per ISO 10993-5
  • 3D printer validation
• Conclusion: These non-clinical tests indicate that the device does not raise new issues of safety or effectiveness compared to the predicate device and is substantially equivalent.

No information is provided in the document regarding:

1. A table of acceptance criteria and reported device performance (in the context of clinical/AI performance): Not applicable for this type of device and submission.
2. Sample sizes used for the test set and data provenance: No clinical test set discussed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable; no ground truth establishment for AI performance.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done; this is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable; this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable; there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

The implants feature a mesh-like structure. The mesh-like structures are designed with the same elementary pattern. This pattern was designed to obtain implants with mechanical properties close to those of bone and to allow for osseointegration.

The TruMatch CMF Titanium 3D Printed Implant can be used in combination with TruMatch CMF Titanium 3D Printed Accessories (patient-specific guides), cleared as SurgiCase guides (K103136) and TruMatch CMF Titanium 3D Printed Implant System (K170272). The guides are intended to aid with implant positioning.

The TruMatch CMF Titanium 3D Printed Implant provides surgeons with a patient-specific implant solution for plastic and reconstructive surgery. The device is constructed based on the patient's CT imaging data.

The TruMatch CMF Titanium 3D Printed Implant is designed to fit the patient's anatomy and is not contoured manually by the surgeon. The TruMatch CMF Titanium 3D Printed Implant is designed and manufactured with integrated screw holes to fixate the bone using: MatrixMIDFACE (K050608), MatrixMANDIBLE (K063790, K121574), MatrixORTHOGNATHIC (K083388), MatrixNEURO screws (K123723, K042365), and Synthes Craniofacial Screw System (K050608).

The TruMatch CMF Titanium 3D Printed Implant contains the following applications:

Reconstruction applications: Orbital
Brand name: TruMatch CMF Ti 3D-Printed Implants
Material: Commercially pure titanium
Type of design: Patient Specific
Type of application: Implant thickness: 0.4-1.5mm
Patient specific associated instrument: Orbital guide

Reconstruction applications: Mandible, midface
Brand name: TruMatch CMF Ti 3D-Printed Implant
Material: Commercially pure titanium
Type of design: Patient Specific
Range of length: 10-294mm
Curvature: 0°-12°/mm length
Type of application: Range of shapes:
Midface reconstruction: Mesh-shaped, contoured to the patient's anatomy One/multi piece One/multi layered
Implant thickness: 0.8-10mm
Patient specific associated instrument: Midface guide
Mandibular reconstruction: Mesh-shaped, contoured to patient's anatomy Single/double strut Straight Curved/crescent Subcondylar Plated extensions One/multi layered Combinations of the above
Implant thickness: 1.2-10mm
Patient specific associated instrument: Mandibular guide

This is a 510(k) summary for a medical device called the "TruMatch CMF Titanium 3D Printed Implant" (K173039). The document focuses on demonstrating that this new device is substantially equivalent to existing, legally marketed predicate devices.

Let's break down the information regarding acceptance criteria and the supporting study, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating performance equivalent to or non-inferior to predicate devices, rather than strict pre-defined numerical thresholds for a novel diagnostic accuracy claim. The performance data presented is focused on various engineering and biological tests.

• Sensitization: In compliance with ISO 10993-10 guidelines.
• Intra-cutaneous reactivity: In compliance with ISO 10993-10 guidelines.
• Systemic toxicity: Test passed and considered negative.
• Chemical characterization: As per report.
• Leachable substances: No toxicological concern remains, further biological testing not justified. |

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

The provided document describes testing for a physical implant, not an AI/ML device that would typically have a "test set" of data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" are not applicable in this context. The "test set" here refers to the physical devices (implants, packaging, materials) that were subjected to the various engineering and biological tests. The document does not specify the exact number of implants or material samples tested for each category (e.g., how many implants for mechanical testing).

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

This section is not applicable as the document describes a physical medical device (implant) and its performance through engineering and biological testing, not a diagnostic or AI/ML device requiring expert-established ground truth. The "ground truth" for these types of tests is generally defined by the standards themselves (e.g., ASTM F382, ISO 10993 series), which specify acceptable performance limits.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in scenarios where multiple human readers assess a case and their interpretations need to be reconciled, typically in AI/ML performance studies.

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

An MRMC comparative effectiveness study is not applicable as this document describes a physical medical implant, not an AI medical device.

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

A standalone performance study of an algorithm is not applicable as this document describes a physical medical implant, not an AI medical device.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the TruMatch CMF Titanium 3D Printed Implant is based on:

• Established Industry Standards and Specifications: For mechanical properties (ASTM F382) and biocompatibility (ISO 10993 series), the acceptance criteria are defined by these internationally recognized standards.
• Sterility Assurance Levels (SAL): For sterilization, the ground truth is a demonstrated SAL of 10^-6, which is a standard regulatory requirement.
• Functional Compatibility: For compatibility with fixation systems, the ground truth is that the device works with the specified Synthes systems.

8. The Sample Size for the Training Set

This is not applicable as the document describes a physical medical implant, not an AI medical device that requires a "training set." The implants are patient-specific and manufactured based on individual patient CT scan data, but this is a manufacturing process, not a machine learning training process.

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

This is not applicable for the same reasons as point 8.

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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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Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Biopor Porous Polyethylene Implants are manufactured of porous high-density polyethylene, a biomaterial that is easily contoured or carved to suit the anatomical and functional requirements of the patient. The interconnecting pores of the Porous HDPE material permits fibrovascular ingrowth into the implant. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC™ Porous Polyethylene Surgical Implants are provided STERILE and should not be resterilized.

The provided text describes a 510(k) premarket notification for a medical device (Biopor Porous Polyethylene Implants) and does not contain information about acceptance criteria for device performance in the context of a study that proves the device meets those criteria.

The document is a regulatory submission to the FDA, demonstrating substantial equivalence to predicate devices, focusing on:

• Device Description: Porous high-density polyethylene implants for maxillofacial skeleton augmentation/reconstruction.
• Intended Use: Augmentation or reconstruction of the maxillofacial skeleton.
• Substantial Equivalence: Claiming substantial equivalence to predicate devices (Ceremed Biopor K141880, Poriferous Su-Por K140437, Stryker Medpor K922489) based on similar intended use, additional shapes and sizes, material properties, and biocompatibility.
• Biocompatibility and Performance Testing: Listing various ISO 10993-compliant tests performed (e.g., Cytotoxicity, Implantation studies, Genotoxicity, Pyrogen test).

Therefore, I cannot provide the requested information, as the input does not contain a study outlining specific performance acceptance criteria, device performance results against those criteria, or details regarding test sets, expert ground truth, adjudication methods, or MRMC studies.

The "performance testing" mentioned refers to a list of standard biocompatibility and material tests (e.g., Cytotoxicity, Implantation studies) rather than a study evaluating diagnostic performance or algorithm effectiveness as might be implied by "acceptance criteria and the study that proves the device meets the acceptance criteria" in an AI/software context.

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Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Porous High Density Polyethylene (HDPE) Surgical Implant

This document is a 510(k) premarket notification decision letter for the Biopor® Porous Polyethylene Implants, indicating substantial equivalence to a predicate device. It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information.

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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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Su-Por® Surgical Implants in block, sheet, and anatomical shapes are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. Su-Por® Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

The Su-Por® Surgical Implants are marketed as single use sterile implants with various shapes and sizes for different areas of the craniofacial skeleton. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The raw material used for the Su-Por® Surgical Implants is high-density polvethylene when molded into the implants becomes a porous high-density polyethylene. Polvethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the Su-Por® Surgical Implants allow for tissue in growth. The material used to manufacture the Su-Por® Surgical Implants has been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene implants for enucleation and evisceration, as well as for many applications in craniofacial reconstruction and augmentation, with a history of safety and performance. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

Here's a summary of the device's acceptance criteria and the study that proves it meets them, based on the provided text:

Device: Su-Por® Surgical Implants

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Su-Por® Surgical Implants are established by demonstrating substantial equivalence to legally marketed predicate devices. This means that the Su-Por® implants must be as safe, as effective, and perform as well as or better than the predicate devices. The performance is assessed across several categories, including material properties, manufacturing processes, packaging, and biocompatibility.

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

The document does not explicitly state a "test set" in the context of a statistical study with a specific sample size. Instead, the evaluation focuses on bench testing and biocompatibility testing of the Su-Por® Surgical Implants themselves.

• Sample Size for Testing: Not specified as a number of "cases" or "patients." The testing involved samples of the device material and manufactured implants for various physical, chemical, and biological assessments.
• Data Provenance: The document does not specify the country of origin for the data or if it was retrospective or prospective. It describes laboratory and material testing.

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

This type of information (number of experts, qualifications, etc.) is typically associated with clinical studies or evaluations where human assessment of medical images or conditions defines the ground truth. This document describes the premarket notification (510(k)) process for a medical implant, which primarily relies on bench testing and established material science standards to demonstrate substantial equivalence to existing devices.

Therefore, there is no mention of experts establishing ground truth in this context, as it's not a diagnostic AI device or a clinical outcome study requiring such a setup.

4. Adjudication Method for the Test Set

As there is no "test set" in the sense of clinical cases requiring expert adjudication, no adjudication method is mentioned or applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms when used by human readers (e.g., radiologists, pathologists) for diagnostic tasks. The Su-Por® Surgical Implant is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This is not an AI device. The evaluation is for a physical medical implant.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on established material science standards, biocompatibility regulations, and predefined physical/chemical properties that define the safety and performance of porous polyethylene implants. The "truth" is whether the material and finished device meet these engineering and biological specifications, and whether they are comparable to predicate devices with a history of safe and effective use.

• Bench Test Results: Passing criteria for impact, flexural, tensile strength, purity, and porosity.
• Biocompatibility Standards: Meeting ISO and USP standards for cytotoxicity, systemic toxicity, intracutaneous reaction, pyrogenicity, and muscle implantation.
• Sterilization Validation: Demonstrated sterility via Ethylene Oxide (EtO).

8. The Sample Size for the Training Set

This concept is not applicable here. There is no AI algorithm being "trained." The Su-Por® Surgical Implant is a manufactured device.

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

This concept is not applicable here, as there is no training set for an AI algorithm.

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OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

The OmniPore® Customized Surgical Implants are marketed as single patient use sterile implants that physicians request as customized surgical implants which use identical materials and manufacturing to the OmniPore® Surgical Implants but are made to a predetermined patient's measurements and size requirements. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The OmniPore Customized Surgical Implants are created from the patient's CT imaging data provided from the physician. The OmniPore Customized Surgical Implants are manufactured from the same material, manufactured under the same processes, and packaged the same as the OmniPore Surgical Implants.

The raw material used for the OmniPore Customized Surgical Implants is high-density polyethylene resin which has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore Customized Surgical Implants allow for tissue in-growth. Additionally, animal histology has shown fibrovascular in-growth occurs into the open pore structure of OmniPore Customized Surgical Implants.

The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

This document describes the OmniPore® Customized Surgical Implants, a device intended for non-weight-bearing applications in craniofacial reconstruction/cosmetic surgery, repair of craniofacial trauma, and augmentation/restoration of contour in the craniomaxillofacial skeleton.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantifiable acceptance criteria for the device's performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device performs equivalently to its predicates across various aspects.

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

The document does not specify a "test set" in the traditional sense of a clinical or retrospective study with patient data for evaluating the device's performance. The evaluation for this 510(k) submission is based on demonstrating equivalence to predicate devices, primarily through material and manufacturing equivalency, and justification from existing predicate testing data.

Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this type of submission which focuses on substantial equivalence rather than a de novo clinical study. The "testing" mentioned refers to justification based on previously conducted tests for predicate devices.

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

This information is not applicable as there is no mention of a clinical "test set" requiring expert ground truth establishment for patient outcomes or diagnoses. The submission relies on scientific and engineering evaluations for material equivalence and manufacturing processes.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a "test set" requiring adjudication.

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

This information is not applicable. The device described is a physical surgical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

Given the nature of the submission (demonstrating substantial equivalence for a physical implant), the "ground truth" is largely:

• Material properties and manufacturing process specifications: Confirming the raw materials, manufacturing methods, and sterilization processes are the same or equivalent to the predicate devices.
• Existing predicate device performance data: Relying on the established safety and effectiveness of the legally marketed predicate devices through their prior biocompatibility, sterilization validation, and mechanical testing results.
• Software verification documentation: For the customization process, ensuring the software performs its intended function for creating the customized implant based on CT data, likely verified against functional requirements and possibly accuracy checks against reference CAD models or similar.

There is no mention of pathology, expert consensus on patient outcomes from a new study, or specific outcomes data for the OmniPore® Customized Surgical Implants itself beyond the predicate justification.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The customization is based on patient-specific CT imaging data for manufacturing, not on a machine learning model trained on a dataset.

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

This information is not applicable for the same reason as point 8.

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