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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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Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Cemented and uncemented applications. The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System. The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Ligament deficiencies. Tumor Resection. Revision of previously failed total joint arthroplasty. Trauma. These are single use implants. These devices are for cemented use only.

The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment). The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.

The provided document is a 510(k) premarket notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments. The content primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed study proving the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not present in this document. The document states:

"Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." (Page 1)
"Clinical Testing: None provided as a basis for substantial equivalence." (Page 1)

This means the submission relies on non-clinical testing and comparison to predicates, not specific clinical performance studies with detailed acceptance criteria as one might find for a novel device requiring more extensive validation.

Given the information provided, here's what can be inferred and what cannot:

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

Missing: Specific quantifiable acceptance criteria (e.g., tensile strength, fatigue life, wear rate thresholds) and the exact numerical performance results for these criteria. The document only provides a general statement of functionality.

2. Sample size used for the test set and the data provenance

Not provided. The document mentions "non-clinical laboratory testing" but does not specify the sample size, type of test specimens, or the provenance of any data used for these tests. It is implied these were laboratory tests on the device itself, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Since the testing was non-clinical and no clinical data was presented, there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set requiring adjudication by experts was presented.

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

No. This device is a medical implant (knee augments), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

No. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by standard engineering and material science specifications, predicate device performance data, and regulatory standards for mechanical and material properties of implants. However, the document does not detail these specific standards or how the device's performance compared against them. It only states it was "functional within its intended use."

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission as it is not a machine learning/AI device.

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

Not applicable/Not provided. As above, no training set was involved.

In summary: The provided 510(k) notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments relies heavily on a comparison to predicate devices and general non-clinical laboratory testing to assert substantial equivalence. It does not contain the detailed performance data, acceptance criteria, sample sizes for patient data, or expert review methodologies that would be typical for clinical studies validating a new diagnostic or AI-driven device. The statement "Clinical Testing: None provided as a basis for substantial equivalence" is key in understanding the limited scope of detailed performance data in this particular document.

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Trabecular Metal Tibial Cone Augments and 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 Tibial Cone Augments and 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 Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.

The Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System. the Trabecular Metal Cone Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.

This 510(k) premarket notification for the Zimmer Trabecular Metal Technology, Inc. Trabecular Metal Tibial and Femoral Cone Augments does not contain a study that proves the device meets specific acceptance criteria in the manner you've described (e.g., related to algorithm performance, human reading, or medical outcomes).

Instead, this submission seeks to demonstrate substantial equivalence to previously cleared predicate devices. Substantial equivalence for medical devices like this typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device. This is often achieved through non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than clinical studies with defined acceptance criteria for diagnostic or AI performance.

Therefore, many of the specific questions you've asked about acceptance criteria for device performance with numerical metrics, expert adjudication, or AI performance are not applicable to this type of 510(k) submission.

Here's an assessment based on the provided text:

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

• Not applicable in this context. This 510(k) does not present a table of specific numerical acceptance criteria for a study proving device performance in the way a diagnostic or AI device approval might. The device is a knee implant augment, and its "performance" is primarily assessed through its material properties, design, and biocompatibility, which are implicitly covered by its substantial equivalence to predicate devices.

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

• Not applicable. There is no mention of a "test set" for performance evaluation in the context of diagnostic or AI accuracy. The "performance data" mentioned in the submission refers to the characteristics that ensure substantial equivalence, which would typically be derived from engineering specifications and testing, not patient data in the sense of a test set for diagnostic accuracy.

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)

• Not applicable. Ground truth in the context of diagnostic accuracy or AI performance is not relevant to this submission. The device is a physical implant.

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

• Not applicable. No test set or human adjudication process is described.

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

• Not applicable. This device is a component of a knee implant system, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable. There is no algorithm associated with this physical implant device.

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

• Not applicable. Ground truth for diagnostic performance is not relevant. The "ground truth" for a device like this would be its physical properties, biocompatibility, and mechanical performance, which are assessed through engineering standards and testing, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. No AI or machine learning model requiring a training set is mentioned.

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

• Not applicable. As no training set is mentioned, this question is not relevant.

Summary of the Document's Approach to "Performance":

The core of this 510(k) submission, regarding "performance," is found in the statement:

"Performance Data: The predicate and subject devices are identical; performance characteristics therefore remain as documented in the predicate submission (K031962 and K051756)."

This indicates that the Zimmer Trabecular Metal Tibial and Femoral Cone Augments are considered to have the same "performance characteristics" as their predicate devices because they are described as "identical." In the context of medical devices like these, "performance characteristics" would typically refer to aspects such as:

• Material properties: Strength, ductility, fatigue resistance, porosity, etc.
• Biocompatibility: Demonstrated through standard biocompatibility tests.
• Mechanical integrity: Ability to withstand loads and stresses inherent in knee joint function.
• Design compatibility: Ensuring proper fit and function with the specified Zimmer knee systems.

Since the devices are stated to be "identical," no new "performance data" is presented in this submission itself; rather, it refers back to the data provided and accepted in the clearance of the predicate devices.

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