(154 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; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolaps) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hemia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
Medeor Matrix 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 bone, provide biomechanical strength for the tendon repair.
Medeor Matrix is intended for one time use.
Medeor™ Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer peel-open packages. The product is either packaged dry (lyophilized) to be hydrated prior to use, or can be supplied prehydrated, packaged and sterilized in saline.
This document describes the performance data for the Medeor Matrix, a surgical mesh, in support of its 510(k) submission. However, it does not describe an AI/ML device or studies typically associated with such devices (e.g., comparative effectiveness studies with human readers, standalone algorithm performance, or ground truth establishment relevant to AI models). Therefore, I cannot extract information related to AI/ML device performance or study design for an AI/ML model from this document.
The document focuses on the traditional regulatory submission requirements for a medical device (surgical mesh), including mechanical testing and biocompatibility studies.
Let's break down what is available in the document regarding its performance criteria and studies for the Medeor Matrix surgical mesh:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a formal table of acceptance criteria with numerical targets. Instead, it states that the device "passed the requirements of all tests" for biocompatibility and "demonstrated equivalence of the device to legally cleared predicate devices" for mechanical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Demonstrated equivalence to legally cleared predicate devices for Tensile Testing and Suture Retention. |
| Biocompatibility Testing | Passed the requirements of all tests conducted per ISO 10993-1:2003, including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity, and Hemolysis. |
| In Vivo Studies | Results not explicitly detailed as "acceptance criteria met," but implies successful outcomes for defect repair in a sheep model and tissue reactions in a rabbit study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical Testing: Sample sizes are not specified for Tensile Testing and Suture Retention.
- Biocompatibility Testing: Sample sizes are not specified.
- In Vivo Studies:
- Sheep model: "defects were repaired and evaluated in a sheep model." Sample size not specified.
- Rabbit study: "a rabbit study was performed to evaluate tissue reactions." Sample size not specified.
- Data Provenance: Not specified within the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device adjudicated by experts.
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
This information is not applicable. No MRMC study was conducted as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI/ML device; therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be the measured physical properties and their comparison to established standards or predicate devices. For biocompatibility, it's adherence to ISO 10993 standards and accepted biological response criteria. For in vivo studies, the "ground truth" would be histological analysis, gross observations, and clinical outcomes in the animal models.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML 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.