Search Results

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

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

• Sample Sizes:
  • Cytotoxicity: Not specified (in vitro study).
  • Murine Local Lymph Node Assay (LLNA): Mouse model, sample size not specified.
  • ISO Modified Intracutaneous Solution: 3 rabbits.
  • USP and ISO Modified Systemic Toxicity: 10 mice.
  • ISO Muscle Implantation: Not specified (rabbits).
  • Genotoxicity (Micronucleus, Bacterial Reverse Mutation, Chromosomal Aberration): Not specified (in vitro studies).
  • Bone Implantation Study: Not specified (rabbits).
  • AOC Polymer Hemolysis: Not specified (in vitro study).
  • PPE Post-irradiation Cytotoxicity: Not specified (in vitro study).
  • ISO Intramuscular Implantation AOC Coated & Uncoated PPE: Not specified (rabbits).
  • Suture Pull-out: Not specified (number of coated implants tested).
  • Flexibility (Sheet Performance): Not specified (number of coated/uncoated implants tested).
  • Porosity Characterization: Not specified (number of coated/uncoated implants tested).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given this is an FDA submission for a medical device, the studies would typically be conducted under Good Laboratory Practice (GLP) standards. The biocompatibility profile was "leveraged from testing to support K043133 (a predicate ancestor of K141880)," indicating a reliance on previously gathered data for similar materials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to this type of device submission. There is no "ground truth" established by experts in the context of diagnostic accuracy for an AI/ML device. The "ground truth" for these tests is based on objective measurements (e.g., cell viability, physical strength, pore size) and established biological responses in animal models, assessed by qualified laboratory personnel and researchers, not expert readers.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in diagnostic imaging studies, not for physical/chemical testing of an implant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device or its testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this pertains to AI algorithm performance which is not applicable here.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Bioreactivity Data: In vitro cell culture responses, observed reactions in animal models (e.g., irritation, sensitization, toxicity, tissue integration).
• Physical Property Measurements: Direct measurements of material properties like pore size and strength.
• Sterility and Endotoxin Levels: Controlled laboratory measurements.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device