(76 days)
The PROLENE Polypropylene Mesh Hernia Device is intended to be used for the repair of indirect and direct inguinal hernia defects.
The PROLENE Mesh Hernia Device is indicated for the repair of inguinal hernia defects, both indirect and direct.
The PROLENE Polypropylene Mesh Hernia Device is a sterile, pre-shaped, three dimensional device constructed of an onlay patch connected by a mesh cylinder to a circular underlay patch. The material is undyed PROLENE* polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* polypropylene nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The device, PROLENE Polypropylene Mesh Hernia Device, is intended for the repair of indirect and direct inguinal hernia defects.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effective in repairing inguinal hernias | Demonstrated effectiveness in repairing inguinal hernias in a preclinical study. |
| Maintains its position in the inguinal canal without the aid of sutures | Demonstrated maintenance of position in the inguinal canal without sutures in a preclinical study. |
| Permits postoperative tissue ingrowth | Demonstrated in a preclinical study. |
| Demonstrates functionality | Demonstrated in a preclinical study. |
| Comparable technological characteristics to predicate device (BARD® Marlex® Mesh PerFix® Plug) | The device is also a pre-shaped, three-dimensional device constructed of knitted polypropylene monofilaments, similar to the predicate. |
| Nonreactive material | Material (PROLENE polypropylene) is reported to be nonreactive when used as a suture. |
| Retains strength indefinitely in clinical use | Material (PROLENE polypropylene) is reported to retain strength indefinitely in clinical use when used as a suture. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that a "preclinical study" was conducted. However, it does not specify the sample size used for this study (e.g., number of animals or specific experimental units). It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
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. The study was a preclinical one, and it's not clear if "experts" in the human clinical sense were involved in establishing ground truth for the animal model.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 done. The study described is a preclinical study, not a clinical study involving human readers.
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 physical surgical mesh and not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth was likely established through observational data and assessment of biological outcomes in the preclinical study. This would include direct observation of hernia repair, assessment of device position, and histological examination to confirm tissue ingrowth and functionality within the animal model.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" for this device would be its design and manufacturing process, and performance verification would come from the preclinical study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML 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.