(41 days)
The INNOVASIS 'X-Box' PEEK Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial canal in hip stem and total knee replacement.
This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
The INNOVASIS 'X-Box' PEEK Cement Restrictor is an implant system for use as a non-load bearing 'cement plug' in orthopedic surgery.
The design of the X-Box include rectangular components of different cross-sectional sizes to accommodate various configurations in the midsection femoral/tibial diaphyseal canal. These various size components will aid in placement and retention of the device in the medullary canal in order to prevent the migration of PMMA cement into the canal for patients receiving orthopedic cemented femoral hip or tibial total knee components. The X-Box is a hollow, PEEK material, rectangular frame with fenestrated sides and exterior ribs.
The device is intended to be used in conjunction with standard PMMA bone cement.
Acceptance Criteria and Device Performance Study for Innovasis 'X-Box' PEEK Cement Restrictor
The provided text does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary for a medical device (PEEK Cement Restrictor "X-Box") and primarily focuses on establishing substantial equivalence to previously marketed devices. It details the device's description, intended use, materials, and asserts safety and effectiveness based on this substantial equivalence, rather than new performance data.
Here's why the requested information cannot be extracted from the provided text:
- No mechanical tests were performed to support this application. The document explicitly states: "No mechanical tests were performed to support this application. The Innovasis PEEK Cement Restrictor is a non-load bearing device." This indicates that no performance study was conducted to generate data against specific acceptance criteria.
- Basis of Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through "substantial equivalence" to predicate devices. This means that if the new device is sufficiently similar to an already approved device, and the predicate device was found safe and effective, then the new device is also considered safe and effective without requiring extensive new performance data.
- Absence of Performance Data Section: The "Performance Data" section in the document directly follows the "Material" section and explicitly states that no mechanical tests were performed. There are no other sections that describe a study, acceptance criteria, or performance data.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided 510(k) summary. The FDA's approval appears to be based on the device's classification as non-load bearing and its material composition being compliant with established biocompatibility standards.
§ 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.