(90 days)
The tibial spacer is a primary component intended for cemented use only in total knee arthroplasty in skeletally mature individuals for treatment of the following:
- Patient conditions of Noninflammatory Degenerative Joint Disease (NIDJD); e.g., avascular . necrosis, osteoarthritis and Inflammatory Joint Disease (IJD); e.g., rheumatoid arthritis;
- Correctable valgus-varus deformity and moderate flexion contracture.
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
These Tibial Spacers are optional components designed to mate with the previously-cleared Natural-Knee II Cemented Modular Tibial Baseplate. Like the Tibial Baseplate, the Tibial Spacers are manufactured from cobalt chrome alloy. The tibial spacers are available in seven sizes (00 through 5) and in two thickness levels. They are available in both medial and lateral and both left and right configurations to match the radial contour of the baseplates.
The provided text is a 510(k) summary for a medical device called "Tibial Spacer for the Natural-Knee® II Cemented Modular Tibial Baseplate." It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical data, statistical analysis, or expert review related to AI/ML or diagnostic performance. The basis of substantial equivalence is stated as "Performance testing, design comparisons, and functional analyses conducted on Tibial Spacers for the Natural-Knee® II Cemented Modular Tibial Baseplate demonstrate that the Tibial Spacer is substantially equivalent to the predicate device."
Therefore, based only on the provided text, I cannot fill out the requested table or answer the specific questions related to acceptance criteria, diagnostic performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not mentioned in the context of this 510(k) submission.
This document is for a traditional medical device (a knee implant component) and not an AI/ML-driven diagnostic or image analysis tool, which is typically where the "acceptance criteria" and "study proving criteria met" for performance metrics like sensitivity, specificity, or AUC would be detailed. The "performance testing" mentioned likely refers to mechanical and biocompatibility testing common for implantable devices, not diagnostic accuracy.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.