(196 days)
PivitAB™ is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
PivitAB™ is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PivitAB™ is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a biorsonable polyarylate coating on the mesh containing the antimicrobial agents, rifampir and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the nesh in order to facilitate interoperative handling during placement and act a carrier for the imicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a ermanent mesh incorporated into the tissue.
The provided text describes a 510(k) premarket notification for the PivitAB™ surgical mesh. This document focuses on demonstrating the substantial equivalence of the PivitAB™ to legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a study designed to meet those criteria.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) summarizes existing data to show equivalence, rather than detailing a de novo study to establish new performance metrics against pre-defined acceptance criteria.
Here's an attempt to address your request based on the provided text, with explanations for what cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | (Implicitly, comparable to predicate devices and acceptable for human implantation as per FDA guidance for surgical mesh.) | "The PivitAB™ and the polyarylate polymer have been demonstrated to be biocompatible." |
| Tissue Ingrowth | (Implicitly, satisfactory and comparable to commercial surgical mesh, as per FDA guidance for surgical mesh.) | "animal testing demonstrated that PivitAB™ will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology." |
| Antimicrobial Effectiveness (In Vivo) | (Implicitly, significantly fewer colonized implants compared to a non-antimicrobial control mesh.) | "Result demonstrated that there were significantly fewer colonized implants with PivitAB (13%) than with the PROLENE Mesh control (43%)." |
| Mechanical Properties / Hernia Repair Performance | (Implicitly, "comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies" as per FDA guidance for surgical mesh.) | "Non-clinical laboratory testing was performed in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies." |
Explanation: The 510(k) submission doesn't explicitly state numerical acceptance criteria in the way a clinical trial protocol would. Instead, it relies on demonstrating comparability to predicate devices and adherence to relevant FDA guidance for surgical mesh. The "reported device performance" is a summary of findings from various non-clinical and animal tests designed to support this comparability and safety.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- For the antimicrobial effectiveness study: The text states "PivitAB™ and a non-antimicrobial coated Control (PROLENE, Ethicon, Sommerville, NJ) were inoculated with 10^5 CFUs of S aureus and implanted into rabbits." While it provides the result (13% vs 43%), it does not specify the number of rabbits or implants used in this study.
- For tissue ingrowth and other non-clinical tests: Not specified.
- Data Provenance: The studies mentioned are referred to as "Non-clinical laboratory testing" and "animal testing."
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: These would typically be prospective studies, especially the animal model for antimicrobial effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the 510(k) summary. "Histopathology" for tissue ingrowth implies expert review by pathologists, but details on their number or qualifications are absent. For the antimicrobial effectiveness, the "ground truth" was the percentage of colonized implants, likely determined through microbiological culture and counting, not expert consensus on an image or clinical observation.
4. Adjudication method for the test set
- This information is not explicitly provided. For the antimicrobial effectiveness study, the method was likely objective measurement (microbial counts), not an adjudication process among human observers.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for medical imaging) where human readers interpret data. The PivitAB™ is a surgical mesh; its effectiveness is assessed through physical, biological, and antimicrobial performance, not human interpretation of diagnostic output. Therefore, there's no "AI assistance" or "human reader improvement" to measure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. PivitAB™ is a physical surgical implant, not an algorithm. Its performance is inherent to the device itself (materials, design, antimicrobial properties).
7. The type of ground truth used
- For Biocompatibility: Likely based on standardized assays and histopathological examination in animal models, comparing responses to established benign materials.
- For Tissue Ingrowth: "Histopathology" is mentioned, indicating microscopic examination of tissue sections as the ground truth.
- For Antimicrobial Effectiveness: The "ground truth" was the presence and extent of microbial colonization on the implants, quantified through microbiological methods (e.g., CFUs - Colony Forming Units) from the explanted devices. This is an objective, laboratory-derived ground truth.
- For Mechanical Properties: Likely engineering tests and physical measurements according to standards.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device that requires a training set. The data presented are from pre-clinical studies and animal models.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of medical device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.