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OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.

The OmniPore DUROMAX Surgical Implants are an extension within the family of OmniPore Surgical Implants. OmniPore DUROMAX Surgical Implants include the addition of pure titanium within the porous high-density polyethylene. They are marketed as single use sterile implants with various sizes. The material used for the OmniPore DUROMAX Surgical Implants is a porous high-density (HD) polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the implants allow for tissue ingrowth. Both of the materials used to manufacture the OmniPore DUROMAX Surgical Implants, the porous HD polyethylene and pure titanium, have been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene and titanium implants for enucleation and evisceration, as well as for reconstruction/cosmetic surgery and repair of the orbital skeletal framework, including orbital floors, walls, rims and roof, with a history of safety and performance. The interconnecting open pore structure of the OmniPore DUROMAX Surgical Implants allow for tissue ingrowth. Additionally, animal histology has shown fibrovascular ingrowth occurs into the open pore structure of porous surgical implants. The other advantage to the OmniPore DUROMAX Surgical Implants is that the titanium structure can be curved or rounded and will hold that shape in the internal orbital skeletal framework. The titanium material contained in OmniPore DUROMAX Surgical Implant is also radiopaque on post-operative CT (computed tomography) scans. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

Acceptance Criteria and Study for OmniPore® DUROMAX® Surgical Implants

This document describes the acceptance criteria and the study that demonstrates the OmniPore® DUROMAX® Surgical Implants meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The performance is assessed through various tests aligning with recognized standards and a comparison of technological characteristics.

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

The document describes material and mechanical testing, not a clinical study with a "test set" in the sense of patient data.

• Sample Size for Material/Mechanical Testing: Not explicitly stated for each test (e.g., how many implants were subjected to bend testing). The document states "Compliance was justified against previous five (5) year shelf life testing and previous mechanical testing," implying these tests were performed on an adequate number of samples to represent the device.
• Data Provenance: The data provenance is from laboratory bench testing and refers to recognized international and US standards (ISO, ASTM, USP). This is not patient data, so concepts like country of origin or retrospective/prospective do not apply.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable as this is not a study involving expert interpretation of medical images or patient outcomes. The "ground truth" for material and mechanical properties is established by the specifications defined in the referenced standards (e.g., ISO 10993, ASTM F67).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies for resolving discrepancies in expert interpretations of medical data. For material and mechanical testing, the "ground truth" is determined by adherence to specified test methodologies and resulting measurements against predefined acceptance criteria from standards.

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

Not applicable. This is not a diagnostic device or an AI-assisted device requiring human-in-the-loop performance evaluation. The device is a surgical implant.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical surgical implant, not an algorithm or AI system.

7. Type of Ground Truth Used (for all studies)

The ground truth for the safety and performance evaluation of the OmniPore® DUROMAX® Surgical Implants is based on:

• International and US Standards: Such as ISO 10993 series (biocompatibility), ISO 11135 (sterilization), ISO 10993-7 (EO residuals), USP , , (pyrogenicity), ASTM D5420 (impact testing), USP (purity), and ASTM D4284 (porosity and ingrowth).
• Established Performance of Predicate Devices: The concept of substantial equivalence heavily relies on demonstrating that the new device shares similar technological characteristics and has similar indications for use as legally marketed predicate devices with a known history of safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this device is a physical implant evaluated through material characterization and mechanical testing, not an AI or machine learning model.

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

Not applicable as there is no training set.

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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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