(137 days)
X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
X-Repair is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
X-Repair is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
The X-Repair is a bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh manufactured from poly-l-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.
The provided text describes a 510(k) summary for the Synthasome X-Repair surgical mesh. However, it does not contain the specific details required to populate a table of acceptance criteria, reported device performance measurements, study design specifics (like sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods), or any information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The document focuses on:
- Device Description: Bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh from PLLA.
- Intended Use: Reinforcement of soft tissue where weakness exists, specifically for tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps).
- Comparison to Predicate Devices: Similar intended use, but different material (PLLA vs. Artelon™ or Vicryl). The document states these differences "do not raise new types of safety or effectiveness questions."
- Summary of Performance Data (General Statement): "The results of performance testing, including biocompatibility, mechanical, and animal testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use and do support a determination of substantial equivalence."
Therefore, I cannot provide the detailed information requested in your bullet points because it is not present in the provided text. The document only offers a high-level statement about performance testing without specific criteria or results.
§ 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.