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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
-Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona Osseo Ti Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add compatibility of the Persona OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System Posterior Stabilized (PS) femoral components. The addition of this compatibility does not change the intended use or fundamental scientific technology of the device system.

The Persona® the Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones. With this submission compatibility of the Persona OsseoTi 3-Peg patella components will be added to the Persona PS femoral components of the knee system. These patella components articulate against femoral component as part of a total knee system. These patellar components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

The provided text is a 510(k) summary for the "Persona the Personalized Knee System." It details the device's indications for use, technological characteristics, and comparison to predicate devices, focusing on the added compatibility of the Persona OsseoTi 3-Peg Patella with Posterior Stabilized (PS) femoral components.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an algorithm or AI performance. The tests mentioned are non-clinical durability tests for mechanical components of a knee prosthesis, performed according to ISO standards. These are physical tests, not studies evaluating software or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device being described.

Here's what can be extracted based on the provided text, while acknowledging that the primary request is not fully addressable due to the nature of the device:

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

Since the device is a knee prosthesis and not an AI/software device, the "acceptance criteria" and "reported device performance" are related to mechanical durability rather than algorithmic accuracy. The document states that durability testing was performed "per ISO 14243-5." This ISO standard would inherently define the acceptance criteria (e.g., number of cycles without failure, wear rates within limits). However, the specific quantitative acceptance criteria and the detailed qualitative or quantitative performance results (e.g., actual wear rates, exact number of cycles completed by the device in the test without failure) are not reported in this summary. It only states that the tests were done.

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

• Sample Size for Test Set: Not applicable in the context of an AI/software test set. For the mechanical durability tests, the "sample size" would refer to the number of prostheses tested. This is not explicitly stated in the provided text.
• Data Provenance: Not applicable in the context of clinical data for AI. These are non-clinical mechanical tests, likely performed in a lab setting by the manufacturer (Zimmer, Inc., based in Warsaw, Indiana, USA).

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 experts interpreting data, is relevant for AI/software evaluations. For mechanical durability testing, the "ground truth" is determined by the physical outcome of the test (e.g., whether a component fractured, or wear measurements). This doesn't involve human experts establishing a ground truth in the interpretative sense.

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

Not applicable. Adjudication methods are used to resolve disagreements among multiple human readers/experts in AI/software evaluations. This is a non-clinical mechanical test.

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 document does not mention any MRMC study. The device is a physical knee prosthesis, not an AI or software product intended to assist human readers.

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

No. This is not an algorithm.

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

Not applicable in the AI/software sense. For mechanical tests, the "ground truth" is the physical measurement or observation of the component's state after rigorous testing (e.g., did it fail, what was the wear rate).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a premarket notification for a physical medical device (knee prosthesis) and its mechanical testing. It does not pertain to an AI/software device, therefore, almost all the specific questions about acceptance criteria and studies for AI performance cannot be answered from this text.

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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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