(229 days)
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.
| Acceptance Criteria Category | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Material Equivalence | Not explicitly stated as a quantitative criterion, but implicit expectation is the materials are identical or perform equivalently to predicate devices. | "The OmniPore® Customized Surgical Implant materials are equivalent materials as the previously cleared OmniPore Surgical Implant devices..." |
| Biocompatibility | Not explicitly stated as a quantitative criterion, but implicit expectation is the device is biocompatible as demonstrated by predicate testing. | "...so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing." (Performance is inferred to be adequate based on predicate.) |
| Sterilization Efficacy | Not explicitly stated as a quantitative criterion, but implicit expectation is terminal sterilization is effective (e.g., Sterility Assurance Level of 10^-6). | "...so the biocompatibility and sterilization validation to validate that they are sterile devices for implantation was justified from the predicate testing." (Performance is inferred to be adequate based on predicate.) The implants are "provided sterile by ethylene oxide (EO) terminal sterilization." |
| Mechanical Properties (Impact, Purity, Porosity) | Not explicitly stated as a quantitative criterion, but implicit expectation is that these properties are equivalent to predicate devices. | "The OmniPore Customized Surgical Implants are equivalent materials as the previously cleared OmniPore Surgical Implant devices so the mechanical testing specific to impact testing, purity testing per USP, and porosity testing was justified from the OmniPore Surgical Implant device testing." (Performance is inferred to be adequate based on predicate.) |
| Software Verification (for Customization Process) | Not explicitly stated, but implicit expectation is that the software used for customized design is validated and functions equivalently to predicate. | "The software verification testing documentation for the OmniPore Customized Surgical Implants was provided to justify equivalence against the MEDPOR® Customized Surgical Implant." (Performance is inferred to be adequate based on predicate, indicating the software part of the device's manufacturing process has been verified.) |
| Clinical Performance / Safety and Effectiveness for Intended Use (Overall Substantial Equivalence) | No specific quantitative clinical endpoints or safety profiles are provided as acceptance criteria in this document. | "The OmniPore® Customized Surgical Implants have the same intended use and indications for use, and the same technological characteristics and principles of operation as the predicate devices. The minor differences do not raise any issues of safety or effectiveness. Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Customized Surgical Implants have equivalent results as the predicate devices." (Summary conclusion of equivalence.) |
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.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.