(143 days)
GORE® SYNECOR PREPERITONEAL Biomaterial is intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.
GORE® SYNECOR Preperitoneal Biomaterial is a composite mesh intended for use in the repair of hernias and abdominal wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material. The device incorporates two distinct functional layers comprised of 1) a polytetrafluoroethylene (PTFE) knit mesh, laminated between 2) two porous synthetic bioabsorbable web layers. The permanent PTFE knit layer functions to provide strength when bridging a hernia or soft tissue defect. The porous bioabsorbable web layers provide a scaffold for tissue ingrowth and vascularization. The GORE® SYNECOR Preperitoneal Biomaterial is for single use only and is designed for preperitoneal placement and should be placed between tissue layers where ingrowth is desired.
The provided document is a 510(k) summary for the GORE® SYNECOR Preperitoneal Biomaterial, a surgical mesh. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.
Below is an analysis of the acceptance criteria and study information based on the provided text, formatted to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative "acceptance criteria" for each performance test in a tabular format with corresponding "reported device performance." Instead, it states that the device "met the intended functional acceptance criteria necessary for providing strength when bridging a hernia or soft tissue defect for up to the stated shelf life" and that "Performance data includes acceptable results for mesh thickness, density, suture retention, burst strength, and pore size relative to the predicate device."
| Performance Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Functional Strength | Sufficient strength for bridging hernias/soft tissue defects for the stated shelf life | "Met the intended functional acceptance criteria necessary for providing strength when bridging a hernia or soft tissue defect for up to the stated shelf life." |
| Physical Properties | Acceptable values relative to the predicate device for mesh thickness, density, suture retention, burst strength, and pore size. | "Performance data includes acceptable results for mesh thickness, density, suture retention, burst strength, and pore size relative to the predicate device." |
| Shelf Life | Supported by known stability of PTFE and real-time/accelerated aging data. | "The three year shelf life is supported by the known stability of PTFE, and real time data correlated with accelerated aging data for the predicate surgical mesh device, GORE® BIO-A Tissue Reinforcement." |
| Biocompatibility | Demonstrates biocompatibility per ISO 10993 standards (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogen, genotoxicity, local effects, subchronic toxicity). | "GORE has demonstrated that these materials are biocompatible in the manufacture of GORE® SYNECOR Preperitoneal Biomaterial device by conducting an extensive battery of standardized in vitro and in vivo tests according to ISO 10993 standards..." |
| Tissue Response (Animal) | Organized, vascularized collagenous tissue ingrowth within the web and macropores, expected inflammatory response, no noteworthy systemic toxicity. | "Overall, the tissue response was similar for these constructs with the presence of organized, vascularized collagenous tissue ingrowth within the web and filling the macropores. Furthermore, the inflammatory response was as expected... no noteworthy systemic toxicity." |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Studies: The document does not specify the exact sample sizes (N-numbers) for each bench test conducted (mesh thickness, density, suture retention, burst strength, pore size). It states "Testing demonstrated..." and "Performance data includes acceptable results..."
- Biocompatibility Studies: The studies were conducted "according to ISO 10993 standards," which typically involve specific sample sizes for each test (e.g., animal numbers for in vivo tests, replicates for in vitro tests), but these are not explicitly detailed here.
- Animal Studies:
- 30-day subcutaneous implant rabbit model: Sample size not explicitly stated for the subject device.
- 90-day rat subchronic toxicity study: "multiple device implants" - specific number not stated.
- 180-day subcutaneous implant study in rabbits: Sample size not explicitly stated.
- Data Provenance: All studies mentioned are pre-clinical (bench and animal studies). The country of origin for the studies is not specified, but the applicant is W. L. Gore & Associates, Inc. with a US address. The studies are prospective in nature, as they involve testing the device under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are pre-clinical (bench and animal studies) and do not involve human diagnostic performance or expert-derived ground truth in the way medical imaging or clinical studies would. The "ground truth" here is objective physical measurements, histopathological findings (for animal studies), and standardized biocompatibility assessments.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Animal study histopathology and biocompatibility assessments would typically involve qualified pathologists and toxicologists, but no "adjudication method" in the context of resolving disagreements among multiple human readers for a test set is described or implied.
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. The device is a surgical mesh; it is not an AI-based diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
- Bench Studies: Objective physical measurements (e.g., mesh thickness, density, suture retention force, burst strength, pore size). The "ground truth" for comparison was the predicate device's performance.
- Biocompatibility Studies: Results of standardized in vitro assays and in vivo animal tests (e.g., presence/absence of cytotoxicity, inflammatory response, systemic toxicity).
- Animal Studies: Histopathological examination of tissue response (e.g., tissue ingrowth, vascularization, inflammatory cell types and extent) and observation for systemic toxicity.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical surgical mesh, not an algorithmic model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.