(113 days)
The PARIETEX™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Parietex™ Composite Ventral Patch is available as a round shape. It is a dual facing mesh composed of a non-absorbable three-dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four flaps made out of a bidimensional monofilament polyester textile and two removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with two poly(glycolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh.
Here's a breakdown of the acceptance criteria and study information for the Parietex™ Composite Ventral Patch, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Parietex™ Composite Ventral Patch were primarily based on demonstrating substantial equivalence to its predicate devices: Parietex™ Composite Mesh (K040998) and Bard Ventralex® Patch (K021736 and K024008). The reported device performance confirmed this equivalence.
| Characteristic Measured | Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Textile Mechanical Performance | Equivalent to Parietex™ Composite Mesh (K040998) | Demonstrated equivalency during characterization testing. |
| Assembly Tensile Strength | Equivalent to Bard Ventralex® Patch (K021736 and K024008) | Demonstrated equivalency via traction testing. |
| Collagen Film Performance (Minimizing Tissue Attachment) | Equivalent to Parietex™ Composite Mesh (K040998) | Demonstrated equivalency in in-vivo animal model. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The specific numerical sample sizes for the bench testing (textile characterization, traction testing) and the in-vivo animal model are not explicitly stated in the provided summary.
- Data Provenance: The studies were conducted by Sofradim Production (a subsidiary of Covidien llc), which is located in France. The data appears to be retrospective as it was collected as part of a premarket notification application (510(k)) to demonstrate equivalence. The animal model study is preclinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given 510(k) summary. The studies described are bench and preclinical (animal model) tests, which typically rely on objective measurements rather than human expert interpretation of images or clinical outcomes for their primary endpoints.
4. Adjudication Method for the Test Set
- This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies among experts. The studies here are bench and animal model tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The studies focused on physical and biological equivalence to predicate devices using bench tests and an animal model, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a surgical mesh, not an algorithm or AI-powered system, so the concept of standalone algorithmic performance does not apply.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations was established through:
- Objective Measurements: For textile mechanical performance and assembly tensile strength, the ground truth was derived from standardized bench testing measurements (e.g., tensile strength, material characterization).
- Preclinical In-vivo Observations: For collagen film performance (minimizing tissue attachment), the ground truth was based on observations and measurements from a representative animal model, comparing the device to the predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical mesh and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this device does not involve a training set for an algorithm.
§ 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.