(10 days)
The PARIETEX® Composite Mesh is used for the reinforcement of tissues,during surgical The PARIETEX Composite Mesil is assurent of incisional hernias, abdominal wall repair, and parietal (i.c. pertaining to the walls) reinforcement of tissues. The non-resorbable threedimensional polyester mesh provides long-term reinforcement of soft tissues. On the dimensional polyester thesh provides form of the every attachment to the mesh in case of direct contact with the viscera.
The PARIETEX® COMPOSITE Mesh is a surgical mesh used during open (laparotomy) procedures or during laparoscopic procedures. The PARIETEX® COMPOSITE Mesh is made from polyethylenc terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance charactcristics of the mesh but serves to separate the coated side of the mesh from underlying tissues to minimize tissue attachment and ingrowth. The PARIETEX® COMPOSITE Mesh is offered in several sizes and shapes to accommodate the type and approach of the surgical procedure.
The PARIETEX® COMPOSITE Mesh is a surgical mesh used for the reinforcement of tissues during surgical repair, specifically for incisional hernias, abdominal wall repair, and parietal reinforcement of tissues. The device is composed of a polyester mesh and a collagen-based hydrogel component. The study described focuses on a modification to the origin of the collagen in the hydrophilic film, changing it from bovine dermis to porcine dermis.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No statistically significant difference in tissue attachment between porcine and bovine collagen products. | A study was conducted that demonstrated no statistically significant difference between the test groups in tissue attachment. Both the porcine and bovine products were successful at minimizing tissue attachments. |
| No difference in cellular inflammatory reaction. | A histological analysis was performed using randomly selected animals. The study found no difference in the cellular inflammatory reaction to the two products (porcine collagen vs. bovine collagen). |
| Physical performance characteristics of the mesh are not affected by the change in collagen origin. | The document explicitly states: "The hydrophilic collagen film does not affect the physical performance characteristics of the mesh." and "The polyester mesh material used is not modified and remains the same as that described in the current PCO file (K002699)." This implies that the acceptance criterion for physical performance was met by maintaining the core mesh material and ensuring the change in collagen source did not alter its function in this regard. Although not explicitly a "reported performance" of the study presented, the unchanged mesh material is a foundational aspect of equivalence. The successful minimization of tissue attachments also indirectly supports adequate physical performance in a functional context. |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The document mentions "randomly selected animals" for the histological analysis and "test groups" for the tissue attachment study. However, the specific number of animals or samples used in these studies is not provided.
- Data Provenance: The studies were conducted as part of the regulatory submission (K040998) for a device manufactured by Sofradim Production in France. The data appears to be prospective as it was generated specifically to demonstrate the equivalence of the modified device. The country of origin of the data is not explicitly stated beyond the sponsor's location (France).
3. Number of Experts and Qualifications for Ground Truth:
- This application does not involve human interpretation of medical images or diagnostic data where "experts" would establish ground truth in the traditional sense of a clinical read. Instead, the ground truth is established through pre-clinical scientific methods (tissue attachment measurements, histological analysis) conducted by qualified researchers/scientists in a laboratory setting.
- Therefore, no specific number or qualifications of "experts" for establishing ground truth in the context of clinical interpretation are mentioned or applicable here.
4. Adjudication Method:
- Not applicable. This study involves pre-clinical animal studies and scientific measurements, not human interpretation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This is a pre-clinical study evaluating material properties and biological response, not a study involving human readers or AI in a diagnostic context.
6. Standalone Performance Study:
- Yes, a standalone performance study was conducted. The studies (tissue attachment and histological analysis) were performed on the device itself (both porcine and bovine collagen versions) to evaluate its biological performance characteristics independent of human interaction in a diagnostic or assistive capacity.
7. Type of Ground Truth Used:
- The ground truth used is based on biological and histological outcomes data obtained from animal studies. This includes quantitative measurements of tissue attachment and qualitative/quantitative cellular inflammatory responses observed through microscopy.
8. Sample Size for Training Set:
- Not applicable. This study is not describing a machine learning algorithm, so there is no training set in the context of AI. The "predicate devices" listed (K002699, K033376) serve as established benchmarks for the current device's performance, but they are not "training sets" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI training set, this question is not relevant. The ground truth for evaluating the device's performance was established through the aforementioned pre-clinical animal studies.
§ 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.