(26 days)
The PARIETEX™ Optimized Composite mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
The PARIETEX™ Optimized Composite Mesh is available in rectangular and round shape. This device is made out of a three dimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and juts out 5 mm over the edge of the reinforcement. A bi-dimensional multifilament polyester textile flap is attached to the threedimensional reinforcement.
The provided text describes a 510(k) summary for the PARIETEX™ Optimized Composite Mesh, which is a surgical mesh. The document focuses on demonstrating the substantial equivalence of the proposed device to previously marketed predicate devices (PARIETEX™ Composite Mesh).
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define specific numerical acceptance criteria (e.g., minimum tensile strength, maximum adhesion score). Instead, it states that the device is "equivalent in performance characteristics" to its predicates and demonstrates "improved mechanical properties" and "equivalent in-vivo minimizing tissue attachment property".
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Properties (e.g., strength, durability) | Improved mechanical resistance of the mesh |
| Minimizing Tissue Attachment In-vivo | Equivalent in-vivo minimizing tissue attachment property |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "pre-clinical study and bench testing" but does not explicitly state the sample sizes used for these tests. It doesn't specify if the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies performed are bench and pre-clinical tests, not human-read studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable, as the tests described are bench and pre-clinical, not involving human interpretation with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The studies were pre-clinical and bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical surgical mesh, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable in this context. The performance tests evaluate the physical properties and in-vivo behavior of the mesh itself.
7. The Type of Ground Truth Used
For the mechanical property improvement, the ground truth would likely be established through standardized engineering tests (e.g., tensile strength, burst strength) compliant with relevant ISO or ASTM standards. This is inherent in "bench testing".
For the minimizing tissue attachment property, the ground truth would be established through a pre-clinical in-vivo study, likely involving histological analysis and gross observation of tissue adhesion, comparing the new mesh to the predicate mesh in an animal model.
8. The Sample Size for the Training Set
Not applicable. The device is a surgical mesh with design modifications, not an AI/ML algorithm that requires a "training set". The "training" for the mesh is in its manufacturing process and design iterations based on testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this physical 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.