(30 days)
This device is indicated for:
- Moderate to severe knee instability
- Sigmificant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or proximal tibia.
- Valgus, varus or flexion deformities
- The salvage of previously failed surgical attempts
- A total femoral replacement consisting of the MOST Options® or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
- Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
- · Fluted stem extensions require the use of either a smooth or Trabecular, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
- · The Trabecular Metal collar may be used cemented or uncemented against the bone.
- All other constructs are for cemented use only.
The Zimmer Segmental System is intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration. The Segmental System provides for cross compatibility between selected components from the MOST Options® System and NexGen® Rotating Hinge Knee System. A total mid-calf to hip replacement can be achieved using the Segmental System. The cleared distal femoral and the proposed distal femoral components are designed to be compatible with standard NexGen patella components.
I am sorry, but the provided text is a 510(k) summary for a medical device (Zimmer Segmental System XT Components), which focuses on establishing substantial equivalence to a predicate device. It does not describe a study that proves the device meets acceptance criteria in the context of an AI/ML device.
Therefore, I cannot extract the information requested regarding:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states under "Clinical Performance and Conclusions:" that "Clinical data and conclusions were not needed for this device." and mentions "results of non-clinical (lab) component fatigue performance testing" but does not provide details on specific acceptance criteria or performance metrics in a way that aligns with an AI/ML device evaluation.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.