(42 days)
Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
The device is intended for single use only.
The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria and the study that demonstrates the Medeor™ Matrix device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Must meet requirements of ISO 10993-1:2003 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis). | The Medeor Matrix surgical mesh passed the requirements of all tests conducted according to ISO 10993-1:2003, including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis. |
| Viral Inactivation | Appropriate levels of viral inactivation. | Manufacturing methods were tested by an independent laboratory to assure appropriate levels of viral inactivation. |
| Mechanical Testing | Not explicitly stated in the provided text, but implied to be sufficient for soft tissue reinforcement. | Mechanical test reports were completed for: |
- Tensile Testing
- Suture Retention. The device passed the requirements of all tests. |
| Hydration Testing | Not explicitly stated, but implied to allow for hydration with various fluids. | Hydration testing was performed using various hydration fluids. The device passed the requirements of all tests. |
| In Vivo Performance | Not explicitly stated, but implied to demonstrate appropriate tissue repair and reaction in animal models. | The device was evaluated in two in vivo studies: - Defects were repaired and evaluated in a sheep model.
- A rabbit study was performed to evaluate tissue reactions. The device passed the requirements of all tests. |
| Substantial Equivalence | Demonstrated equivalence to predicate devices (Medeor™ Matrix (K091499) and KN ECM Surgical Patch (K094061)) in materials, intended use, and technological characteristics. | Performance Testing confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify exact sample sizes for each test within the performance data section. However, it indicates the following studies were conducted:
- Biocompatibility Tests: The tests were conducted "on the finished device," implying a sufficient number of samples for each specific test mandated by ISO 10993-1:2003.
- Mechanical Tests (Tensile Testing, Suture Retention): Samples of the Medeor™ Matrix were used for these tests.
- Hydration Testing: Samples were tested with "various hydration fluids."
- In Vivo Studies:
- Sheep Model: Defects were repaired and evaluated in a sheep model. The specific number of sheep is not provided.
- Rabbit Study: A rabbit study was performed to evaluate tissue reactions. The specific number of rabbits is not provided.
Data Provenance:
The data was generated through laboratory testing and animal studies. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, implying the data would be acceptable to U.S. regulatory standards. All studies appear to be prospective in nature, as they were specifically conducted to evaluate the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the context of human interpretation or review. The evaluation of the device relied on standardized laboratory tests (biocompatibility, mechanical, hydration) and animal models (in vivo studies). The "ground truth" for these tests would be the established scientific and engineering principles, and the interpretation of results would be by qualified laboratory personnel and researchers, rather than a panel of clinical experts adjudicating cases.
4. Adjudication Method for the Test Set
Not applicable. The reported studies (biocompatibility, mechanical, in vivo) are objective tests with predefined pass/fail criteria based on scientific standards and observations, not on expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers evaluating medical images or data, with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The Medeor™ Matrix is a surgical mesh, not an AI-powered diagnostic device, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not conducted. The Medeor™ Matrix is a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
The ground truth for the various tests was based on:
- Established Industry Standards: For biocompatibility, adherence to ISO 10993-1:2003.
- Inherent Material Properties: For mechanical testing (tensile strength, suture retention) and hydration properties, the measurements are objective.
- Biological Response: For viral inactivation and in vivo studies (sheep model for repair, rabbit study for tissue reactions), the ground truth was the observable biological outcomes and whether they met safety and performance expectations.
8. Sample Size for the Training Set
Not applicable. The Medeor™ Matrix is a physical surgical mesh and not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.