(269 days)
The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repar of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
The 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. In vitro testing showed that the fast-resorbing fiber (glycolide, lactide and trimethylene carbonate) loses its mechanical strength after 2 weeks and in vivo studies in the abdominal wall of sheep showed that the fast-resorbing fiber is fully absorbed after 4 months. The same in vitro testing showed that the slow-resorbing fiber (lactide and trimethylene carbonate) maintains its mechanical strength for 6 months and in vivo studies in the abdominal wall of sheep indicated that the slow-resorbing fiber is absorbed after approximately 36 months.
The provided text discusses the TIGR Matrix Surgical Mesh and its substantial equivalence to predicate devices, focusing on technical characteristics and clinical performance to support its expanded indications for use and extended shelf life.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence based on the device being the same as a reference predicate (K163005) and having similar characteristics to a primary predicate (K161424). Performance is discussed qualitatively and through comparative attributes.
Below is a table summarizing the claimed performance and characteristics, primarily in comparison to the predicate devices:
| Characteristic | Acceptance Criteria (Implied by Predicate/Discussion) | Reported Device Performance (TIGR® Matrix Surgical Mesh) |
|---|---|---|
| Shelf Life | N/A (Previous: 36 months for K163005) | 48 months (Extension supported by additional accelerated and real-time aging studies). |
| Biocompatibility | In accordance with ISO 10993 | Biocompatibility testing in accordance with ISO 10993-1 conducted and demonstrates biocompatibility for intended body contact and duration. (Same as K163005, which states biocompatibility for intended use as a permanent, tissue-contacting, implant device). |
| Bench Testing | Demonstrates safety and performance | Performed as described in K163005, demonstrating safety and performance for intended use and substantial equivalence to primary predicate. Initial burst strength > 350N (compared to 170-750N for existing products). Mechanical strength maintained well above 16N/cm between 0 and 26 weeks. |
| Animal Testing | Demonstrates safety and performance | Performed as described in K163005, demonstrating safety and performance for intended use and substantial equivalence to primary predicate. In vivo studies in sheep showed fast-resorbing fiber fully absorbed after 4 months and slow-resorbing fiber absorbed after approximately 36 months. |
| Human Factors | Demonstrates safety and performance | Performed as described in K163005, confirming safety and performance. Labeling indicates size and length; can be manipulated with gloved hand. Has been used in US clinics since 2010. |
| Clinical Efficacy (Hernia Repair) | Comparable to primary predicate/predicate devices for soft tissue reinforcement. Low recurrence rates and absence of mesh-related complications. | Recurrence rate: 12% initially, decreased to 4.5% (3/66) after improvements (e.g., TAR approach). |
| Wound complication rate: 27% (25/91). | ||
| Mesh-related complications: 0% (no mesh-related complications, no mesh removal required). | ||
| Mean follow-up: 42.4 months (1-102 months). | ||
| Mesh Thickness (mean) | Comparable to K163005 | 0.687 mm (Same as reference predicate K163005). |
| Area Weight/Density (mean) | Comparable to K163005 | 125 ≤ X ≤ 170 g/m² (Same as reference predicate K163005). |
| Porosity | Comparable to K163005 | 20 ≤ X ≤ 40 % (Same as reference predicate K163005). |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 (Same as primary and reference predicates). |
2. Sample Size Used for the Test Set and Data Provenance
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Clinical Data Test Set (for hernia repair):
- Sample Size: 91 patients.
- Data Provenance: Real-world clinical evidence from a surgical hernia program. Implied to be retrospective as it describes data collected between 8/2011 and 9/2015. The geographic origin is not explicitly stated but "US clinics" is mentioned, suggesting U.S. data.
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Bench, Animal, Biocompatibility, Human Factors Testing: These tests are stated to be "described in (K163005)" for the reference predicate. Specific sample sizes for these tests are not provided in this document, but they were part of the previous submission for the K163005 clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the clinical data regarding hernia repair:
- The ground truth was established by surgeons' clinical practice within a Clinical Quality Improvement (CQI) program.
- The document implies that these were multiple surgeons as part of a "surgical hernia program."
- Qualifications: Not explicitly stated, but they are referred to as "surgeons" performing "abdominal wall reconstruction (AWR) operations," indicating medical expertise in this surgical field. Years of experience are not mentioned.
4. Adjudication Method for the Test Set
- The clinical data was collected as part of a Clinical Quality Improvement (CQI) program and reflects "real-world clinical evidence."
- There's no mention of an independent adjudication method (e.g., 2+1, 3+1 consensus by external experts) for the patient outcomes (recurrence, complications). The outcomes were presumably recorded by the treating surgical team as part of their standard clinical practice and CQI process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- The clinical data presented is on the performance of the TIGR Matrix Surgical Mesh itself, not on how human readers/surgeons improve with or without AI assistance. This device is a surgical mesh, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical surgical mesh, not an algorithm or AI product. Its performance is intrinsic to the material and its interaction with the human body, not a software component.
7. Type of Ground Truth Used
- Clinical Outcomes Data: For the hernia repair clinical data, the ground truth was based on documented patient outcomes (recurrence rates, wound complication rates, mesh-related complications) as observed and recorded in real-world clinical practice.
8. Sample Size for the Training Set
- Not applicable. This submission pertains to a physical medical device (surgical mesh), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
- The clinical data of 91 patients served to support the expanded indication, which could be considered an evaluation of the device in practice.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm. The clinical outcomes data cited (91 patients) was collected from routine surgical practice as described in point 3 without specific ground truth establishment for a training set.
§ 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.