(23 days)
PROGRIP™ Self-Gripping Polypropylene Mesh is intended for the reinforcement of tissue during surgical repair.
Parietene™ Flat Sheet Mesh is intended for the reinforcement of tissue during surgical repair.
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
Parietene™ Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.
PROGRIP™ Self-Gripping Polypropylene Mesh: The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
Parietene™ Flat Sheet Mesh: Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.
The provided text describes a 510(k) submission for two surgical mesh devices, PROGRIP™ Self-Gripping Polypropylene Mesh and Parietene™ Flat Sheet Mesh. The submission seeks to add a new formulation of raw material (polypropylene) from the same yarn supplier.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate devices (K101197 and K991400) in: | Demonstrated through bench and preclinical tests. |
| - Indication | No changes to intended use or indications for use. |
| - Raw materials | New polypropylene formulation from the same yarn supplier. |
| - Performance characteristics | Evaluated by bench testing in accordance with FDA's March 2, 1999 Guidance for Surgical Mesh. |
| - Biocompatibility | Conducted in accordance with ISO 10993-1 for a permanent implant (FDA recognized standard #2-156). |
| - Stability | Stability studies conducted, and proposed devices' shelf life demonstrated. |
The document states, "The results of the bench and preclinical tests demonstrate that proposed devices are substantially equivalent to the predicates Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400)." This implies that the device met the acceptance criteria by demonstrating substantial equivalence through various tests.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the performance studies. It mentions "bench testing" and "preclinical tests." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.
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 studies mentioned are bench and preclinical tests, which typically do not involve expert interpretation for ground truth in the same way clinical image analysis studies would.
4. Adjudication Method for the Test Set
This information is not provided as the studies are bench and preclinical tests, not clinical studies requiring adjudication of output.
5. 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
No such study was conducted or mentioned. This submission is for a surgical mesh, not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device (surgical mesh), not an algorithm or AI system. The performance studies are focused on the material properties and biocompatibility of the mesh.
7. The Type of Ground Truth Used
For the bench testing, the ground truth would likely be established through standard engineering and materials science measurements, comparing the new material's performance to established specifications or the predicate devices' performance.
For biocompatibility, the ground truth would be established through standard cytotoxicity, sensitization, irritation, etc., testing as per ISO 10993-1, determining if the material elicits an unacceptable biological response.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical surgical mesh 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.