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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:

2. Sample Size Used for the Test Set and Data Provenance

• 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.

• 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.

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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.

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.

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