(90 days)
The PROLENE Hernia System is intended to be used for the repair of abdominal wall hernia defects.
The PROLENE (Polypropylene) Hemia System is indicated for the rs of the controllers in defects The PROLEINE (1 Siffect propped and hernia defects.
The PROLENE Hernia System is a sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong underlay patch. The material is undyed PROLENE* Polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* Polypropylene non-absorbable 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 provided text describes a 510(k) summary for the PROLENE* (Polypropylene) Hernia System, a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document explicitly states: "Nonclinical laboratory testing was not performed." and concludes that the "new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act."
Based on the information provided, it is not possible to complete the requested table or answer the questions related to acceptance criteria and a study proving device performance, as such a study with quantifiable metrics and ground truth establishment was not performed or reported in this 510(k) submission.
Summary of available information regarding performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | "The modified device has identical technological characteristics to the predicate device." |
Explanation for other criteria where information is not available:
- Sample sized used for the test set and the data provenance: Not applicable, as no dedicated test set or clinical study was performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth was established through expert review for a performance study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical hernia repair system, not an AI-based diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hernia repair system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study requiring ground truth was conducted.
- The sample size for the training set: Not applicable, as no training set for an algorithm was used.
- How the ground truth for the training set was established: Not applicable.
The submission focuses on the device's technological characteristics being identical to a predicate device, supporting substantial equivalence rather than a de novo demonstration of performance against predefined acceptance criteria.
§ 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.