(50 days)
Synergy™ Tissue Matrix is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons,
Synergy Tissue 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 tissue to the bone, provide biomechanical strength for the tendon repair.
Synergy Tissue Matrix is an implantable biologic mesh comprised of non-crosslinked bovine pericardium. Synergy Tissue Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
Here's a breakdown of the acceptance criteria and study information for the Synergy™ Tissue Matrix, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 compliance | Acceptable and equivalent to predicate devices. |
| Viral inactivation | Satisfactory results (implied by overall biocompatibility). | |
| Pyrogen testing | Satisfactory results (implied by overall biocompatibility). | |
| Residual chemicals assessment | Satisfactory results (implied by overall biocompatibility). | |
| Biomechanical Performance | Tensile strength | Equivalent to predicate devices and satisfies mechanical performance requirements for intended use. |
| Burst strength | Equivalent to predicate devices and satisfies mechanical performance requirements for intended use. | |
| Suture pull-out strength | Equivalent to predicate devices and satisfies mechanical performance requirements for intended use. | |
| Physical/Chemical/Structural Characterization | (General characterization) | Comparable to predicate devices. |
| In Vivo Performance | Tissue response/functionality | Normal tissue healing response and confirms remodeling capability. |
| Substantial Equivalence | Materials | Equivalent to Veritas and PROPatch. |
| Physical characteristics | Equivalent to Veritas and PROPatch. | |
| Performance characteristics | Equivalent to Veritas and PROPatch. | |
| Biological attributes | Equivalent to Veritas and PROPatch. | |
| Indications for Use | Substantially equivalent to OrthADAPT, PROPatch, and CuffPatch (with specific exclusions). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical studies with human subjects or a defined dataset for AI evaluation. The evaluations are primarily based on:
- Bench Testing: Mechanical properties (tensile strength, burst strength, suture pull-out) would involve samples of the device itself. No specific sample sizes are mentioned.
- Animal Implant Studies: These are in vivo (live animal) studies. The number of animals used is not specified.
- Biocompatibility Testing: Conducted in vitro (laboratory) or in vivo (animal) according to ISO 10993-1. Specific sample sizes are not provided.
The provenance of the data is not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical/laboratory-based and animal studies, not human clinical trials. They are likely prospective for the specific tests performed on the Synergy™ Tissue Matrix.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical mesh; the ground truth for its performance is established through objective physical, chemical, and biological testing as well as animal studies, not through expert consensus on interpreting data (like images).
4. Adjudication Method for the Test Set
Not applicable, as the evaluation methods are objective measurements and animal observations, rather than interpretation by multiple 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
Not applicable. This is a medical device (surgical mesh), not an AI/software-as-a-medical-device (SaMD) that involves human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device is based on:
- Objective measurement standards: For biocompatibility (e.g., ISO 10993-1), pyrogenicity, residual chemicals.
- Engineered performance metrics: For biomechanical properties (tensile strength, burst strength, suture pull-out).
- Histopathological and physiological observations: From animal implant studies (normal tissue healing, remodeling capability).
- Chemical and physical characterization: Material composition, structure, etc.
These are established by recognized scientific and engineering principles and standards, not expert consensus on ambiguous data.
8. The Sample Size for the Training Set
Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.
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.