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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 is to 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 the Tibia baseplate and cemented to the prepared tibia.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

The provided text describes a 510(k) premarket notification for the "Apex Knee™ System," a knee joint prosthesis. However, the document does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device.

The document is a submission for a physical medical device (a knee implant), not an AI device. Therefore, the questions related to AI device performance (e.g., number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical implant, primarily through material characterization, mechanical testing, and biocompatibility testing. The "acceptance criteria" discussed are mainly related to the performance standards for the implant materials and design, such as wear testing, strength testing, and sterility assurance levels.

Here's a breakdown of what is and is not in the provided text:

Information NOT Found (as it pertains to an AI device):

• 1. Table of acceptance criteria and reported device performance for an AI device: Not present. The acceptance criteria relate to mechanical and biological properties of the implant.
• 2. Sample size and data provenance for an AI test set: Not applicable. The "test set" refers to mechanical samples and animal models, not patient data for AI evaluation.
• 3. Number of experts and qualifications for AI ground truth: Not applicable. Ground truth for an AI device (e.g., image annotation) is not relevant here.
• 4. Adjudication method for an AI test set: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI: Not applicable.
• 6. Standalone (algorithm only) performance for AI: Not applicable.
• 7. Type of ground truth for an AI device: Not applicable. Ground truth here refers to engineering specifications and biological response, not diagnostic labels for AI.
• 8. Sample size for an AI training set: Not applicable.
• 9. How ground truth for an AI training set was established: Not applicable.

What the document does provide regarding the physical device's "studies":

The document broadly mentions "non-clinical testing" conducted to demonstrate the safety and effectiveness and substantial equivalence of the modified Apex Knee™ System. These tests are the "study" proving the device meets its acceptance criteria (though not presented in the AI-specific format requested).

• Testing for Pegged Tibial Baseplates:
  • FEA (Finite Element Analysis) simulation
  • Peg location templating study
• Testing for ECiMa Tibial Inserts & Patellae:
  • Material characterization
  • PS (Posterior Stabilized) post strength testing
  • Insert disassembly strength testing
  • Wear testing
• Biocompatibility Testing for ECiMa material:
  • Intramuscular implantation in animal models
  • Implant toxicity and subcutaneous implantation in animal models
• Sterility: Validated sterilization process using ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10-6. Endotoxin testing via Limulus amebocyte lysate (LAL) on a quarterly rotating basis for product groups.

Conclusion:

This document is a regulatory submission for a physical knee implant and does not contain the specific information requested regarding AI device acceptance criteria and study methodologies. The "studies" mentioned are engineering and biological tests demonstrating the physical device's performance and safety.

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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.

Ask a specific question about this device