(204 days)
The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects. It is not intended to be used for the reconstruction of cardiovascular defects.
The Reperen® Surgical Mesh is made from a biocompatible, hydrophobic acrylic polymer. The implant has two distinct layers: 1st layer is a smooth transparent film of spatially cross-linked acrylic polymer with polyamide mesh embedded inside. The 2nd layer is a mesh of spatially cross-linked acrylic polymer, interconnected forming the rough surface. The thickness of the reinforcing layer (in the total thickness of the Reperen® Surgical Mesh) is 0.1 + 0.05 mm. The roughness of the parietal layer for Reperen® Surgical Mesh (all sizes) is about 100 um.
The Reperen® Surgical Mesh is available in six different sizes as described in the table below.
| Designation | Shape | Size in mm | Thickness in mm, | Weight in gm | |
|---|---|---|---|---|---|
| $\pm 3$ mm | $\pm 0.15$ mm | $\pm 20%$ | |||
| 1. | Reperen®-15-150-100 | 150 x 100 | 0.4 | 5.4 | |
| 2. | Reperen®-15-200-150 | oval | 200 x 150 | 0.4 | 10.8 |
| 3. | Reperen®-15-250-150 | 250 x 150 | 0.4 | 13.5 | |
| 4. | Reperen®-15-250-200 | 250 x 200 | 0.4 | 18.0 | |
| 5. | Reperen®-15-300-200 | 300 x 200 | 0.4 | 21.6 | |
| 6. | Reperen®-15-370-280 | 370 x 280 | 0.4 | 37.2 |
The provided document is a 510(k) summary for the Reperen® Surgical Mesh, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on a clinical study where "performance" is measured in terms of diagnostic accuracy or similar metrics for AI/software devices.
Therefore, the typical questions regarding AI/software device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.
This document describes a surgical mesh, which is a physical implant, and its performance is evaluated through physical and biological testing, as well as an animal study, to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the available information in the context of device acceptance, though it won't perfectly fit the requested AI/software performance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Reperen® Surgical Mesh) was subjected to performance and biocompatibility testing and an in vivo animal study to determine its substantial equivalence to a predicate device, GORE® DUALMESH® BIOMATERIAL (K992189). The document states that the device "met all specified design and performance requirements."
Since this is a 510(k) summary for a physical mesh, the "acceptance criteria" are related to physical properties and biocompatibility, not diagnostic performance. The document doesn't explicitly list numerical acceptance criteria with corresponding performance values but states compliance.
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Performance Testing: | |
| Mesh Thickness | Met specified design requirements |
| Mesh Density | Met specified design requirements |
| Suture Retention Strength | Met specified design requirements |
| Tear Resistance | Met specified design requirements |
| Uniaxial Tensile Stress | Met specified design requirements |
| Ball Burst Testing | Met specified design requirements |
| Mesh Stiffness | Met specified design requirements |
| Biocompatibility Testing (per ISO 10993-1): | |
| Cytotoxicity | Met specified design requirements |
| Sensitization | Met specified design requirements |
| Irritation or Intracutaneous reactivity | Met specified design requirements |
| Systemic toxicity (acute) | Met specified design requirements |
| Subchronic Toxicity | Met specified design requirements |
| Genotoxicity | Met specified design requirements |
| Implantation (with histology) | Met specified design requirements |
| Hemolysis | Met specified design requirements |
| Pyrogenicity | Met specified design requirements |
| Chemical Characterization Studies | Met specified design requirements |
| Animal Studies | Performance substantially equivalent to predicate device (mechanical strength, tissue response, clinical efficacy) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for physical/biocompatibility testing): Not specified in terms of numerical sample sizes for each test, but standard test methods would dictate appropriate sample numbers. The tests are laboratory-based, not patient data-based.
- Test Set (for animal study): Described as "In vivo porcine studies." The exact number of animals is not specified in this summary.
- Data Provenance: The physical and biocompatibility testing were laboratory-based. The animal study involved "porcine" (pig) models. This is prospective experimental data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable as this is not a diagnostic device or AI software. "Ground truth" for a physical device like a surgical mesh is established by standardized physical measurements, chemical analyses, and histopathological evaluations, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing.
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
Not applicable. This is not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" is derived from standardized physical and mechanical measurements against predefined specifications (e.g., thickness, tensile strength limits). For biocompatibility, it's defined by biological responses within acceptable limits according to ISO 10993 standards and histopathological findings in the animal study.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.