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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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