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The Precision Casting Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The Precision Casting Solutions Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Precision Casting Solutions Total Knee System is designed for cemented use only.

The Precision Casting Solutions Total Knee System is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented knee prosthesis that consists of a femoral component, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Precision Casting Solutions Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.

The provided text describes a medical device, the "Precision Casting Solutions Total Knee System," and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm or software as a medical device (SaMD).

The document is a 510(k) summary for a physical medical implant (a knee replacement system), which follows a different regulatory pathway and testing methodology than an AI/ML system. The performance testing mentioned (fatigue, strength, contact area, range of motion) are mechanical tests relevant to a physical orthopedic implant.

Therefore, I cannot provide the requested information for an AI/ML device based on the given text. The text does not mention:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set or data provenance
3. Number of experts and qualifications to establish ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone (algorithm-only) performance
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. Sample size for the training set
9. How ground truth for the training set was established

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