(90 days)
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.
The Miromatrix Biological Mesh is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The Miromatrix Biological Mesh is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.
Acceptance Criteria and Study for Miromatrix Biological Mesh
This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Miromatrix Biological Mesh.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Miromatrix Biological Mesh were established by comparing its performance to a predicate device (K980431, SurgiSIS Surgical Mesh) based on recommendations in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," dated March 2, 1999." The device met these criteria by demonstrating comparable safety and mechanical properties.
| Test Category | Acceptance Criteria / Performance Measures | Reported Device Performance |
|---|---|---|
| Biocompatibility | Demonstrate comparable safety profile to the predicate device. Tests included: In Vitro Cytotoxicity, Skin Sensitization (Maximization Method), Intracutaneous Reactivity, Acute Systemic Toxicity, In Vitro Bacterial Reverse Mutation (AMES), In Vitro Chromosome Aberration, In Vitro Mammalian Cell Gene Mutation, Intramuscular Implantation, In Vitro Hemolysis, Pyrogenicity, Sub-Chronic Systemic Toxicity. | Biocompatibility testing showed a comparable safety profile to the predicate device. |
| Bench/Laboratory Testing | Demonstrate mechanical properties substantially equivalent to the predicate device for reinforcing soft tissue. Tests included: Tensile Strength, Suture Retention Strength, Burst Force, Tear Resistance, DNA Residuals, Collagen Analysis, Viral Inactivation, Endotoxin, Expiration Dating. | Bench testing demonstrated that the mechanical properties of the mesh are substantially equivalent for reinforcing soft tissue. The specific results for each parameter (Tensile Strength, Suture Retention Strength, Burst Force, Tear Resistance, etc.) are not detailed but are stated as meeting the equivalence criteria. |
| Animal Testing | Demonstrate tissue incorporation into the mesh. | A 30-Day Rat Implantation Study demonstrated tissue incorporation into the mesh. |
Summary of Substantial Equivalence: Based on the indications for use, technological characteristics, and performance test results, the Miromatrix Biological Mesh was determined to be substantially equivalent to the predicate device.
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each test (e.g., number of samples for tensile strength, number of animals in the rat study).
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a new device, the studies are inherently prospective.
3. Number, Qualifications, and Adjudication Methods of Experts
These sections are not applicable as the provided document describes the regulatory submission for a medical device (surgical mesh), not an AI/algorithm-based diagnostic or assistive system that typically involves expert review of images or data. The evaluation relied on standard physical, chemical, and biological testing, not expert interpretation of results in a clinical context.
4. Adjudication Method
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The Miromatrix Biological Mesh is a physical implantable device, not an AI or algorithm that assists human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Miromatrix Biological Mesh is a physical implantable device; it does not involve algorithms or standalone performance in the context of AI.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Biocompatibility Standards: Established guidelines and methods for assessing the biological response to materials, including specific tests for cytotoxicity, systemic toxicity, sensitization, etc.
- Mechanical Property Standards: Industry-recognized physical tests to measure properties like tensile strength, suture retention, burst force, and tear resistance.
- Histological Evaluation from Animal Studies: Direct observation and analysis of tissue response and incorporation within the rat implantation study.
Essentially, the ground truth was established by recognized scientific and engineering principles and experimental results, rather than clinical outcomes or expert consensus on interpretations.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in the computational sense. The "training" in the context of device development would refer to the iterative design and testing phases, but not a formal training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons above.
§ 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.