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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 OsseoTi 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 a new component to the Personalized Knee System, the component is the Persona Ti-Nidium PPS Femurs. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous coated Ti-6Al-4V femoral component will be added to the system. These femoral components articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The new femoral 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 describes the regulatory clearance for the Persona Ti-Nidium PPS Femurs, a component of the Personalized Knee System, but it does not contain the specific details required to answer your questions about acceptance criteria and study design.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validation studies with acceptance criteria in the way you've outlined for software or AI-driven medical devices.

Here's why the information you're asking for is not in the text:

• Device Type: This submission is for an orthopedic implant (knee prosthesis components), not a diagnostic software or AI device. The regulatory pathway and what's typically reported in these summaries are different. Performance for orthopedic implants is usually evaluated through biomechanical testing, material characterization, and sometimes clinical follow-up for the overall system, rather than metrics like sensitivity, specificity, or AUC based on expert reads of images.
• Focus of the Document: The document is primarily an FDA clearance letter and a 510(k) summary. It confirms the device's substantial equivalence to previously cleared predicate devices. It lists the types of non-clinical tests performed (e.g., fatigue, wear evaluation, material characterization) but does not provide the acceptance criteria for these tests or detailed results against those criteria. It states that "Clinical Testing Not Applicable," indicating that a clinical study with human subjects for efficacy was not required for this 510(k) clearance.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance (in the context of AI/software metrics).
2. Sample size used for a "test set" (as in expert-labeled data) or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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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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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 OsseoTi 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 a new component to the Personalized Knee System. The component is the Persona OsseoTi 3-Peq Patella and the associated instruments. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones. With this submission a new porous metal backed UHMWPE patella component will be added to the system. These patellar components articulate against femoral component as part of a total knee system. The new 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. To aid the implantation of these devices several new reusable instruments are also introduced.

The provided text is an FDA 510(k) clearance letter for the "Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)". This document primarily addresses the substantial equivalence of a new medical device to existing legally marketed devices, rather than detailing the acceptance criteria and the rigorous study design typically associated with a de novo approval or a premarket approval (PMA) application that would involve extensive clinical trials with pre-defined acceptance criteria.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Specific type of ground truth used.
• Training set sample size or how its ground truth was established.

Instead, the FDA 510(k) process is about demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on non-clinical performance testing and a comparison of technological characteristics and indications for use.

The relevant section for performance data in this document is under "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)". This section lists several mechanical and characterization tests performed on the device:

• Shear and Torsional Strength of the Persona Link OsseoTi Patella Polyethylene -Ti6Al4V Interface
• Fatigue Strength of the Persona OsseoTi Porous Patella in an Undersupported Bending Configuration and Manufactured Using PQ Process Parameters
• Shear Fatigue Strength of Persona OsseoTi Porous Patella Pegs Manufactured Using PQ Process Parameters
• Durability Testing, per ISO 14243-5, for the Persona OsseoTi 3- Peg Patella when Articulated with a Persona CR Femoral Component
• Expanded In Vivo RF-Induced Heating Simulations for the Persona Primary Knee System
• Characterization of As-Printed Four-Point Bend Fatigue Strength
• Evaluation of the Interfacial Motion Between the Persona OsseoTi Patella and a Bone Analog When Subjected to Physiologically Derived Patellofemoral Joint Kinetics and Kinematics
• Characterization of OsseoTi Lattice

However, the document states: "Clinical Testing Not Applicable". This explicitly indicates that human-in-the-loop performance studies, multi-reader multi-case studies, or standalone algorithm performance studies with human data (which would require establishing ground truth from expert consensus or pathology) were not conducted or deemed necessary for this 510(k) clearance.

The conclusion drawn by the applicant is that:

• "any differences [from the predicate] do not raise new questions of safety and effectiveness; and"
• "the proposed device is at least as safe and effective as the legally marketed predicate device(s)."

This illustrates that for a 510(k) submission, the "proof" often comes from extensive non-clinical testing demonstrating equivalence in mechanical properties, materials, and design features, rather than clinical efficacy trials involving patients or human readers interpreting diagnostic images.

Ask a specific question about this device

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.

Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Persona™ Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. The addition of the Trabecular Metal™ femoral component will provide surgeons with the ability to implant with, or without cement (biological fixation).

The Zimmer® Persona™ Personalized Knee System is a medical device for knee replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing an extensive study report with detailed acceptance criteria and performance metrics typically found in efficacy trials.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Clinical data and conclusions were not needed for this device" because it is a Class II device demonstrating substantial equivalence to existing predicate devices. Therefore, the acceptance criteria are met by demonstrating that the new device exhibits similar or identical performance characteristics to these predicate devices through non-clinical (bench) testing. The acceptance criteria are implicit in the FDA guidance documents followed for testing.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document does not specify the exact sample sizes (number of components tested) for each non-clinical bench test. These details would typically be found in the full test protocols and reports, but are not included in this summary.
• Data Provenance: The data provenance is "Non-Clinical Performance and Conclusions," meaning the tests were conducted in a laboratory setting (bench testing) rather than on human subjects. This is not retrospective or prospective clinical data. The location of the testing laboratories is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is not applicable. For bench testing of medical devices like knee implants, ground truth is established by engineering specifications, material properties, and relevant industry standards (e.g., ISO, ASTM), rather than expert medical consensus on patient cases. The "experts" involved are likely engineering and materials science professionals who design and conduct the tests according to the FDA guidance.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. Since this submission relies on non-clinical bench testing, such an adjudication method is not relevant. The "adjudication" is essentially the adherence to pre-defined test protocols and acceptance criteria based on FDA guidance and engineering standards.

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 knee implant, not an AI-powered diagnostic tool requiring MRMC studies to assess the impact of AI on human reader performance.

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

Not applicable. As above, this is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is established by:

• Engineering Specifications: Designed tolerances, material strengths, and fatigue limits.
• Industry Standards: ASTM, ISO, and other relevant standards for orthopedic implant testing.
• FDA Guidance Documents: The specific guidance documents cited (e.g., Class II Special Controls Guidance Document for Knee Joints, Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces, Guidance for MR Safety) define the methods and performance expectations for validating the device's properties.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be the extensive research and development phases involving finite element analysis, material science studies, and repeated experimental bench testing, but these are not considered "training sets" in the context of AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the AI sense for this device.

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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.
  Porous coated tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This submission describes the Zimmer Persona Personalized Knee System. The device is a modular knee prosthesis for resurfacing the articulating surfaces of the femoral, tibial, and patellar bones. The submission focuses on non-clinical performance and a comparison of the device's material characteristics to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for each test. However, it indicates that "bench testing outlined below was conducted according to FDA guidance documents," which implies that appropriate sample sizes were used as per relevant standards (e.g., ISO 14243 for wear testing).
• Data Provenance: The data is from non-clinical bench testing performed by Zimmer, Inc., a company located in Warsaw, IN, USA. This is prospective data generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This submission relies on non-clinical bench testing, not expert-derived ground truth from human data. The "ground truth" for these tests comes from established engineering and biocompatibility standards and predicate device performance.

4. Adjudication Method:

• Not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in interpretation. This submission focuses on objective bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This submission describes the clearance of a medical device based on non-clinical performance data and substantial equivalence to predicate devices, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance (Algorithm Only):

• Not applicable. This device is a physical knee prosthesis, not an AI algorithm. Its "performance" is assessed through its mechanical, wear, and material characteristics, not through algorithmic accuracy.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is derived from:
  • Established engineering standards: Such as ISO 14243 for wear testing.
  • FDA guidance documents: Which outline appropriate test methodologies and performance expectations for orthopedic implants.
  • Predicate device characteristics: The Vivacit-E material characteristics for the Persona Knee System are stated to be "identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370)," and other performance metrics are compared to "Persona Conventional UHMWPE articular surfaces."

8. Sample Size for Training Set:

• Not applicable. This submission describes a physical medical device, not an AI system that requires a "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable. As above, there is no AI training set involved.

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