(35 days)
TissueMend Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
TissueMend Soft Tissue Repair 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. TissueMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.
TissueMend is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.
The provided 510(k) Premarket Notification for TissueMend Soft Tissue Repair Matrix does not contain information about acceptance criteria or a study proving device performance against such criteria.
This document primarily focuses on establishing substantial equivalence to a predicate device (OrthoMend, K051766) based on technological characteristics and biocompatibility, rather than performance metrics.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria or Performance Data: The document does not list any specific performance metrics (e.g., tensile strength, tear resistance, degradation rate, clinical outcomes) that the device must meet, nor does it provide results from any study designed to assess such performance.
- Focus on Substantial Equivalence: The core of this 510(k) is to demonstrate that TissueMend is "substantially equivalent" to an already legally marketed device. This often involves comparing device design, materials, manufacturing process, and intended use, rather than conducting new clinical performance studies that establish acceptance criteria.
- Biocompatibility Assessment: A "rigorous biocompatibility assessment" is mentioned, indicating tests like cytotoxicity, sensitization, etc. However, these are general safety assessments and not performance criteria for its intended use as a soft tissue repair matrix. The results of these tests (e.g., "demonstrated the biocompatibility") are reported qualitatively, not against numerical acceptance thresholds.
- Viral Inactivation: Similarly, "manufacturing methods... were also tested by an independent laboratory to assure safe levels of viral inactivation." This is a process validation and safety measure, not a performance criterion for the device's functional use in reinforcing soft tissues.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, experts, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided 510(k) summary.
The document's purpose is to satisfy regulatory requirements for market clearance by demonstrating equivalence, not to detail the full performance validation studies that might be conducted internally by the manufacturer or required for a PMA application.
§ 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.