(388 days)
PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the PolyGraft™ BGS Cement Restrictor. It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure. However, the document does not contain or reference any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Specific performance metrics for the device.
- Clinical study details like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on regulatory approval, specifically indicating a warning that the device is not intended for spinal indications and that its safety and effectiveness in the spine have not been established. It also outlines general FDA regulations and requirements.
Therefore, I cannot provide the requested information based on the given text.
§ 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.