(24 days)
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
- · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity:
- · Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to the femoral component and cemented to the prepared femur.
The proposed devices are intended to be used for primary and revision total knee replacement.
The fluted femoral stems and the keeled femoral stems are slight modifications of the existing designs. The femoral stems offer enhanced press-fit implantation and torsional stability by adding longitudinal raised ribs similar to most stems designs currently marketed.
The notched 10mm posterior femoral augment has been created to increase the product offerings when using posterior augments. The new notched augment will allow a 10mm distal augment and 10mm posterior augment to be used together.
The femoral Locking Bolt functions similarly to the tibial locking bolt. It was designed for femoral use for enhanced fixation of the stem to the femur.
The current tibial peg offers additional torsional stability when added to the modular tibial baseplate. The proposed revision tibial Peg is a slight modification of that existing tibial peg and is improved in size and torque strength. The Augment Peg Bolt is similar to the tibial peg and can be used to add additional torsional stability to the modular tibia baseplate when augments are used.
The material of each new component is titanium alloy Ti-6Al-4V E.L.I (ASTM F136)
The provided document is a 510(k) premarket notification for a medical device called the "Apex Revision Knee System." It details the device's indications for use, its description, and the manufacturer's assertion of substantial equivalence to previously cleared devices.
Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for artificial intelligence (AI) or software-based medical devices.
This 510(k) is for a physical medical device (a knee prosthesis), not a diagnostic AI system or a decision support software. The "study" referenced in the document (KTR-102 Femur Stem Bolt Testing Justification, KTR-100 Revision Knee Fluted Stem FEA Comparison, etc.) are engineering justifications and comparisons to existing predicate devices, primarily through finite element analysis (FEA) and design comparisons, not clinical trials or performance assessments against specific numerical acceptance criteria for an AI system.
Therefore, I cannot fulfill your request for the tables and study details related to AI device performance based on the provided text. The information you are seeking (AI acceptance criteria, human reader improvement with AI, ground truth establishment, sample sizes for training/test sets, expert qualifications, etc.) is simply not present in this type of regulatory submission for a physical orthopedic implant.
If you have a document describing an AI medical device, please provide that, and I would be happy to assist with your request.
§ 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.