(224 days)
OmniPore® Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
The OmniPore® 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 OmniPore® Surgical Implants is high-density polyethylene when molded into the implants becomes a porous high-density polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore® Surgical Implants allow for tissue in growth. Additionally, Animal histology has shown fibrovascular ingowth occurs into the open pore structure of OmniPore Surgical Implants. The material used to manufacture the OmniPore® 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.
The provided text describes a 510(k) submission for the OmniPore® Surgical Implants. This is a medical device application for market clearance in the United States, based on substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial would.
Therefore, the requested information elements related to clinical study design, such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets, are not applicable to this type of submission. The submission focuses on demonstrating equivalency of materials, manufacturing processes, and performance characteristics to a legally marketed predicate device.
Here's a breakdown of the available information in the context of your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary) |
|---|---|---|
| Material Biocompatibility | Cytotoxicity Testing | Substantially equivalent materials as predicate devices. |
| ISO Systemic Toxicity | Substantially equivalent materials as predicate devices. | |
| ISO Intracutaneous Study | Substantially equivalent materials as predicate devices. | |
| USP Pyrogen Study | Substantially equivalent materials as predicate devices. | |
| ISO Muscle Implantation Study | Substantially equivalent materials as predicate devices. | |
| Sterilization Validation | Sterilization Validation | Validated to be sterile devices for implantation, equivalent to predicate devices. |
| Mechanical Performance | Impact Testing | Completed, results support substantial equivalence. |
| Material Purity | Purity Testing per USP | Completed, results support substantial equivalence. |
| Material Porosity | Porosity Testing | Completed, results support substantial equivalence. |
Study Proving Acceptance Criteria:
The "study" in this context is the collection of tests performed to demonstrate substantial equivalence to the predicate device, not necessarily to meet pre-defined numeric performance thresholds for clinical outcomes. The manufacturer states:
- "The OmniPore® Surgical Implants were tested to the biocompatibility standards to demonstrate that they are substantially equivalent materials as the predicate devices in regards to Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study."
- "The OmniPore® Surgical Implants completed sterilization validation to validate that they are sterile devices for implantation as equivalent to the predicate devices."
- "The OmniPore® Surgical Implants completed mechanical testing specific to impact testing, purity testing per USP, and porosity testing."
- "Testing results support the determination of substantial equivalence with the results demonstrating that the OmniPore Surgical Implants have equivalent results as the predicate devices."
The regulatory decision (K123908) from the FDA indicates that the device was found substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, indications for use, and technological characteristics, and any minor differences do not raise new questions of safety or effectiveness.
Non-Applicable Information for a 510(k) Submission of this Nature:
- Sample size used for the test set and the data provenance: Not described for clinical performance, as this is a substantial equivalence submission based on material and mechanical testing, not a clinical study. The "test set" here refers to the samples of the implant material subjected to the various physical and chemical tests listed above. No human or patient data is mentioned in relation to proving performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a clinical sense, is not established for material characterization and mechanical testing. The "experts" are the lab technicians and scientists conducting the standardized biocompatibility, sterilization, and mechanical tests.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to material and mechanical testing.
- 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 physical implant, not an AI/software device involving human readers or interpretation of medical images.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the clinical sense. For the material properties, the "ground truth" is defined by established international standards (e.g., ISO, USP) for biocompatibility, sterility, and material characteristics.
- The sample size for the training set: Not applicable. This is a physical implant, not an AI/machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 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.