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510(k) Data Aggregation
(125 days)
Biopor® Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.
Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene (PPE), a biomaterial that is contoured or carved to suit the anatomical and functional requirements of the patient. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend (AOC). Biopor® Porous Polyethylene Implants are provided STERILE and must not be resterilized.
The provided FDA 510(k) summary document for the Biopor Porous Polyethylene Implants does not describe a study involving an AI/Machine Learning device or a diagnostic device where the acceptance criteria would be related to performance metrics like sensitivity, specificity, or reader improvement.
Instead, this document is for a physical medical implant (Preformed Alterable Cranioplasty Plate). The "performance testing" described in the document refers to biocompatibility and physical/mechanical properties of the implant, not diagnostic accuracy or AI algorithm performance.
Therefore, I cannot provide the information requested in your prompt because it pertains to the performance evaluation of an AI/ML or diagnostic device, which is not what this document describes.
However, I can extract the "acceptance criteria" and "reported device performance" as they relate to the physical and biological characteristics of the implant described in this document.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
The "acceptance criteria" for this device are related to its material properties, biocompatibility, and physical performance as an implant. The "study" refers to a series of tests conducted to ensure safety and function.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests | ||
| Cytotoxicity Study Using the End-Point Titration | No cytotoxicity detected | The extract tested negative after 24, 48 and 72 hours. No cytotoxicity detected. |
| Murine Local Lymph Node Assay (LLNA) | Not considered sensitizing | Under the conditions of the study, the material was not considered sensitizing to the mouse. |
| ISO Modified Intracutaneous Solution | Negligible irritation | The primary irritation index characterization for the test article was negligible. |
| USP and ISO Modified Systemic Toxicity | No evidence of systemic toxicity | There was no evidence of systemic toxicity. |
| ISO Muscle Implantation | Classified as a non-irritant | After 2 weeks, the test article was classified as a non-irritant. |
| Genotoxicity: Mouse Bone Marrow Micronucleus | No evidence of cellular toxicity | The coating showed no evidence of cellular toxicity. |
| Genotoxicity: Bacterial Reverse Mutation | No evidence of cellular toxicity | The coating showed no evidence of cellular toxicity. |
| Genotoxicity: In Vitro Chromosomal Aberration | No evidence of cellular toxicity | The coating showed no evidence of cellular toxicity. |
| Bone Implantation Study in the Femur of the Rabbit | Normal healing and absorption of test article (where applicable) | The test article was absorbed and all sites were healing normally. |
| AOC Polymer Hemolysis | Non-hemolytic | The test article was non-hemolytic. |
| PPE Post-irradiation Cytotoxicity | Non-cytotoxic | The test articles were non-cytotoxic. |
| ISO Intramuscular Implantation AOC Coated & Uncoated PPE | Fibrovascular ingrowth indicates tissue integration/compatibility. | Fibrovascular ingrowth occurred into coated and uncoated implants. |
| Physical/Mechanical Tests | ||
| Suture Pull-out of AOC-Coated Biopor Porous Polyethylene Implant | Meet acceptance criteria (specific numerical criteria not detailed in this summary, but implied by "met") | The test articles met acceptance criteria. |
| Biopor Sheet Performance Qualification | Meet acceptance criteria for flexibility (specific criteria not detailed) | The test articles met acceptance criteria. |
| Porosity Characterization of Porous Polyethylene Implants | Pore size greater than 40 µm | The test articles met acceptance criteria (implying pore size was > 40 µm). |
| Endotoxin Specification |
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