(272 days)
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
TIGR® Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
This document is a 510(k) premarket notification for the TIGR® Matrix Surgical Mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating this equivalence through comparative performance data rather than independent clinical efficacy trials with pre-defined success metrics.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh, K092224). The reported device performance is compared directly against that of the predicate.
| Parameter | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Description | ||
| Fast-resorbing fiber | Degrades after 2 weeks (in vitro), absorbed after 4 months (in vivo) | Equivalent, established as equivalent in-vitro; fast-resorbing fiber fully absorbed after 4 months (sheep study) |
| Slow-resorbing fiber | Maintained strength for 6 months (in vitro), absorbed after ~36 months (in vivo) | Equivalent, established as equivalent in-vitro; slow-resorbing fiber absorbed after ~36 months (sheep study) |
| Technical Characteristics | ||
| Classification | Class II: polymeric surgical mesh | Class II: polymeric surgical mesh |
| Indication for use | Reinforcement of soft tissue where weakness exists | Reinforcement of soft tissue where weakness exists |
| Contraindications | Same as subject device | Same as predicate device |
| Mesh Thickness (mean; mm) | 0.573 | 0.687 |
| Area weight/density (mean; g/m²) | $125 \le x \le 170$ | $125 \le x \le 170$ |
| Porosity (%) | $20 \le x \le 40$ | $20 \le x \le 40$ |
| Weave characteristics | Multifilament, Warp knitted, Mesh | Multifilament, Warp knitted, Mesh |
| Ranges of sizes (mm) | 120x65 to 200x300 | 100x150 to 200x300 |
| Materials | Copolymers (Glycolide, L-lactide and Trimethylene carbonate) | Copolymers (Glycolide, L-lactide and Trimethylene carbonate) |
| Sterility | Sterile EO, SAL 10^-6 | Sterile EO, SAL 10^-6 |
| Shelf Life | 1 year | 2 years |
| Nonclinical Performance Data | ||
| Ball burst strength/Force (Mean; N) | ≥ 250 | ≥ 250 |
| Suture pull-out strength (Mean; N) | ≥ 20 | ≥ 20 |
| Tear Strength (Mean; N) | ≥ 30 | ≥ 30 |
| Stiffness (Bending Modulus; MPa) | ≥ 10 MPa | ≥ 10 MPa |
| Relative Distention at 16N (%) | ≤ 8 | ≤ 8 |
| Degradation Characteristics | Not explicitly quantified, but established | Established as equivalent in-vitro. |
| Biocompatibility | Established | Established |
| Shelf life | 1 year | 2 years |
Note: For the subject device, most parameters are presented as being equivalent or meeting the same threshold as the predicate. Changes in thickness, size range, and shelf life are noted but justified as not impacting substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This is not a traditional "test set" in the context of an AI/algorithm study. The studies described are in vitro (bench testing) and in vivo (animal studies) non-clinical tests.
- Bench Testing: The document does not specify exact sample sizes for each bench test beyond "mean" values, indicating multiple samples were tested. The data provenance is internal testing performed by Novus Scientific AB or contract laboratories (BIOMATECH and NAMSA). This is prospective testing for the subject device and referenced predicate data for the predicate device.
- Animal Studies:
- Rat Study: 30 rats in total (2 groups of 5 rats for each of 3 time periods - 1, 3, and 6 months).
- Sheep Study: 13 sheep in total. Each observation period (4, 9, 15, 24, 36 months) comprised 3 sheep with 10 test meshes and 2 control meshes.
- Data Provenance: Prospective animal studies. Locations of animal studies are not explicitly stated, but the contract labs (BIOMATECH and NAMSA) are mentioned for biocompatibility, which might overlap.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device and study type. Ground truth for non-clinical studies is based on standardized test methods, biological endpoints (e.g., histology), and laboratory analyses conducted by qualified personnel following GLP requirements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human expert review in diagnostic studies. Here, evaluation is based on scientific methods and observable biological/material responses.
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 a surgical mesh, not a diagnostic AI system or medical imaging device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical studies:
- Bench Testing: Ground truth is established by physical measurements and adherence to specified standards (e.g., ASTM D3787, ISO 9073-4, ASTM D1388, ASTM D6775).
- Biocompatibility Testing: Ground truth is established by universally recognized biological responses documented through various ISO 10993 tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity, local effects after implantation). This includes microscopic observations and chemical characterization.
- Animal Studies: Ground truth is based on observed biological responses, tissue remodeling, implant degradation, and histological analysis within the animal models.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI 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.