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Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

The NexGen® Trabecular Metal™ Femoral Cone Augments are manufactured wholly of Trabecular Metal™, porous tantalum. The existing, commercially available NexGen® Trabecular Metal™ Femoral Cone Augments have a tapered elliptical cross-section. The periphery of the distal end is larger than that of the proximal end. The cone is not fully enclosed at its top most proximal section (giving the impression of U-Shape through slot). A similar pattern is also present in the modified femoral cones, with the exception that these cones are fully enclosed at its top most proximal section.

Both the modified femoral cones augments and the existing, commercially available femoral cone augments are to be used in conjunction with Zimmer's NexGen® Complete Knee Systems -both the Legacy® Constrained Condylar Knee (LCCK) Stemmed Femoral Implant and the femoral component of Zimmer's Rotating Hinge Knee (RHK) System. When used with the RHK System, the Trabecular Metal™ Femoral Cone Augments are for cemented use only. Fixation of all of the cone augments to the femoral implant is accomplished by cementing the internal portion of the augment to the superior side (non-articulating side) of the femoral component. Apposition of the cone to bone inside the medullary canal is with or without cement when used with the LCCK femoral implant and with cement for the RHK femoral implant.

The existing, commercially available augments come in three sizes; small, medium and large and three height options. The proposed additional femoral cones will come in the same three sizes: small, medium and large and two height options.

Here's an analysis of the acceptance criteria and study information based on the provided text:

This document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results for novel performance criteria. As such, information regarding AI-specific studies, ground truth establishment, and expert involvement for evaluation of an AI model will not be found in this type of submission.

Therefore, many of the requested categories related to AI performance metrics cannot be directly extracted from this document. The "device" in question is a physical orthopedic implant, not an AI system.

1. A table of acceptance criteria and the reported device performance

• Static shear
• Axial compression fatigue
• Rotational beam fatigue
• Young's modulus of elasticity (in tension and compression) |
  | Mechanical Performance (Predicate Devices) | Maintain assembly integrity using surgical technique instructions after: | - Fatigue testing
• Wear testing
• Assembly torque testing |
  | Mechanical Performance (Proposed Device - Strength) | Adequately meets predetermined requirements for mechanical performance during normal gait activities (walking, stair ascent/decent, deep flexion). | - Comparative Finite Element Analysis (FEA) study demonstrated adequate strength. |
  | Substantial Equivalence | - Same material as previously cleared predicate devices.
• Identical intended use and indications for use as predicate devices.
• Similar sizes, cross-sectional dimensions, design features, and overall geometry to predicate device.
• No significant differences that would adversely affect product use.
• No new issues of safety and efficacy raised by technological characteristics. | - All criteria met and detailed in the "DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES" and "CONCLUSION" sections. The FDA concurred with substantial equivalence (K103517). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not applicable. The "tests" here are mechanical engineering tests (material properties, fatigue, wear, FEA), not human subject or imaging dataset evaluations for an AI model. The sample sizes for these engineering tests are not specified in the summary, nor is the "provenance" in the context of data origin relevant for these types of physical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts & Qualifications: Not applicable. This information is relevant for AI model validation where human experts establish ground truth for image interpretation or diagnosis. For mechanical testing of an orthopedic implant, "ground truth" is typically defined by engineering specifications, material standards, and validated simulation models, carried out by engineers and material scientists. The document does not specify the number or qualifications of experts involved in the material property or FEA analyses beyond stating that analyses were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI performance evaluations to resolve disagreements among human annotators or diagnosticians when establishing ground truth. For mechanical engineering tests and FEA, the results are typically derived algorithmically or through physical measurement against established engineering standards, not through expert adjudication in this typical sense.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study / AI Assistance: No. This device is a physical knee implant, not an AI system. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Algorithm Performance: No. This device is a physical knee implant, not an AI algorithm. "Standalone performance" in this context refers to the algorithm's performance without human interaction, which is not applicable. The device itself performs its mechanical function "stand-alone" in the body, but this is a different meaning than used for AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the mechanical aspects, the "ground truth" is based on:
  • Engineering Specifications and Standards: "Predetermined requirements established for its mechanical performance."
  • Material Science Principles: Properties of Trabecular Metal™ measured against established scientific understanding.
  • Validated Mechanical Testing Methods: Fatigue, wear, and assembly torque testing.
  • Finite Element Analysis (FEA) Models: Computational models validated against physical principles and potentially prior experimental data.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This submission is for a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable. No AI model or training set is mentioned in the document.

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