(14 days)
The Medtronic Sofamor Danek CEMENT RESTRICTOR is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Medtronic Sofamor Danek Cement Restrictor is NOT intended for any spinal indications.
The Medtronic Sofamor Danek CEMENT RESTRICTOR is a hollow, titanium and cylindrical frame with a tapered surface. The device is intended to be used in conjunction with standard PMMA cement.
The Medtronic Sofamor Danek CEMENT RESTRICTOR implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.
The provided text is a 510(k) summary for the Medtronic Sofamor Danek CEMENT RESTRICTOR, which describes the device, its intended use, and its substantial equivalence to a previously cleared device. It also includes the FDA's clearance letter. However, this document does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on the regulatory clearance process for a modified geometry of an existing device, emphasizing its substantial equivalence to the predicate device (K003718). It states: "A Design Review for the modified device was provided in this submission." This suggests that the clearance relied on demonstrating that the new geometry did not alter the fundamental characteristics or performance that were deemed acceptable for the original device, rather than requiring a new, extensive performance study with acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The text does not detail:
- Acceptance criteria or reported device performance metrics.
- Sample sizes for test sets, data provenance, or details on training sets.
- The number or qualifications of experts, or adjudication methods for establishing ground truth.
- Any multi-reader multi-case comparative effectiveness study or related effect sizes.
- Stand-alone algorithm performance (as this is a physical medical device, not an AI algorithm).
- The type of ground truth used for performance evaluation.
§ 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.