(7 days)
PARIETENE PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.
PARIETENE PROGRIP™ Mesh is available in 2 forms:
• Pre-cut, elliptic slit mesh with self-gripping overlapping flap
(right or left side)
• Rectangular simple mesh
These meshes and the overlapping flaps of the pre-cut versions
are made of knitted monofilament polypropylene with polylactic
acid (PLA) resorbable pins on one of the sides. The PLA pins
facilitate placement, positioning and fixation of the overlapping
flap and the mesh to the surrounding tissue. A colored yarn
marker on the medial edge of the pre-cut mesh helps orientation.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Characteristics (General): The device should be equivalent in performance characteristics to the predicate device. | Equivalent in Performance Characteristics: Testing has shown that the PARIETENE PROGRIP™ is equivalent in performance characteristics to the predicate PARIETEX PROGRIP™. |
| Material Biocompatibility: The device materials should be biocompatible. | Biocompatible Materials: PARIETENE PROGRIP™ Mesh is comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only states "Bench testing has been conducted to evaluate the performance characteristics of PARIETENE PROGRIP™." It does not specify the sample size for this testing. It also does not specify the provenance of data (e.g., country of origin, retrospective/prospective), as it appears to be lab-based bench testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Bench testing typically does not involve human expert adjudication in the way clinical studies do.
4. Adjudication Method for the Test Set
This information is not provided as the evaluation was based on bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a medical device for surgical hernia repair, not an AI diagnostic tool. Therefore, there is no information about human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable as the device is a surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation appears to be established through bench testing results compared to the predicate device's known performance characteristics. This is a direct comparison of physical properties and performance metrics rather than a clinical ground truth like expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical surgical mesh and not an AI/machine learning model that would require a 'training set'.
9. How the Ground Truth for the Training Set was Established
This information is not applicable due to the nature of the 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.