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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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona porous and cemented non-porous CR femoral components, Persona CR or UC articular surface components, and the cemented nonporous Persona Natural cemented 5 degree tibial components without a stem extension,

Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona porous 0 degree OsseoTi Spiked Keel Tibia which is 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 three new components to the Persona Personalized Knee System. These components consist of a non-porous cemented stemmed tibial baseplate, a porous OsseoTiTM non-cemented tibial baseplate, and a porous plasma sprayed femur. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The Persona 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 plasma sprayed femoral component will be added to the system. These femoral components articulate against tibial and patellar articular surface to form a total knee system. In addition, two new tibial plates will be added, a cemented non-porous stem tibial baseplate and a porous OsseoTiTM stemmed tibial baseplate. All of the new 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 a 510(k) summary for the Zimmer® Persona™ Personalized Knee System. It is a regulatory document from the FDA, and it focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and results for a novel AI/device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI-based or similar novel medical device. The information requested (acceptance criteria table, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is typically found in submissions for AI/ML-based devices or other novel technologies that require demonstrating performance against specific metrics.

This document describes a joint replacement system and its components, and the "Summary of Performance Data" section lists non-clinical tests (e.g., fatigue testing, material evaluations, Bacterial Endotoxin Test) and explicitly states "Clinical Tests: - None provided."

To directly answer your request based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not available. The document lists non-clinical tests (e.g., fatigue testing, material evaluations) but does not provide specific quantitative acceptance criteria or reported performance values for these tests.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set in the context of an AI/ML algorithm evaluation is described. The non-clinical tests would have their own sample sizes for the materials or components tested, but these are not provided in this summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic or AI-based performance test is mentioned.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 document does not describe an AI-assisted device or an MRMC study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. No training set is mentioned as this device is not an AI/ML product.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) pertains to a knee prosthetic system and relies on demonstrating substantial equivalence through similar intended use, indications, materials, design features, and sterilization to predicate devices, along with non-clinical mechanical and material testing. It does not describe a performance study with acceptance criteria in the manner you've outlined for an AI/ML or diagnostic device.

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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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.

Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) 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. With this submission, femoral components made from Titanium alloy (ASTM F136) that undergo the Ti-Nidium nitriding surface hardening treatment are being added to the system. These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. This design is available in multiple sizing options to accommodate a wide range of anatomies. "Narrow" femoral components have a smaller M/L dimension than the "Standard" femoral components. This femoral component, when used with a PS articular surface component, can accommodate a maximum active flexion of 155°, and when used with a Constrained Posterior Stabilized (CPS) articular surface, can accommodate a maximum active flexion of 135°. These femoral components are provided sterile and single use.

The provided document is a 510(k) premarket notification letter and summary for the Persona® Personalized Knee System. This document does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML medical device.

Instead, it pertains to a knee prosthesis, which is a physical implant, not an AI/ML device. The document details the components of the knee system, its intended use, indications for use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to predicate devices. There is no mention of an algorithm, AI, machine learning, or software performance in this context.

Therefore, I cannot fulfill your request for information about acceptance criteria and study proving device meets acceptance criteria for an AI/ML device based on this input. The information provided describes a traditional medical device (knee implant) and its regulatory clearance process, which involves different types of testing (e.g., mechanical, wear, MRI compatibility) and substantial equivalence arguments, rather than the performance metrics and study designs typically associated with AI/ML device validation.

Ask a specific question about this device

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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.

Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) 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. With this submission, femoral components made from Titanium alloy (ASTM F136) that undergo the Ti-Nidium nitriding surface hardening treatment are being added to the system. These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. This design is available in multiple sizing options to accommodate a wide range of anatomies. "Narrow" femoral components have a smaller M/L dimension than the "Standard" femoral components. This femoral component, when used with a CR or Medial Congruent (MC) articular surface, can accommodate a maximum active flexion of 155°, and with an Ultra Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. These femoral components are provided sterile and single use.

The provided text describes a 510(k) premarket notification for the "Persona® Personalized Knee System," a knee prosthesis. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving a device meets specific performance acceptance criteria for an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for an AI/ML device is not applicable to this document.

The document explicitly states:

• Clinical Tests: "Clinical data was not deemed necessary for the subject device." This strongly indicates that performance metrics, such as those you'd establish for an AI/ML algorithm's accuracy or efficacy in a clinical setting, were not assessed for this submission.
• Purpose of Submission: The purpose is for "the addition of the Ti-Nidium cruciate retaining (CR) femoral components to the Persona Personalized Knee System." This is a hardware modification, not an AI/ML software submission.
• Basis for Substantial Equivalence: It's based on "Intended Use: Identical to predicates," "Indications for Use: Identical to predicate," "Materials: Similar to predicates," "Design Features: Identical to predicate," and "Sterilization: Identical to predicate." These are general device characteristics, not performance metrics for an intelligent system.

However, I can extract the non-clinical tests performed, which serve as the "proof" for the modified hardware component, albeit not in the context of AI/ML performance acceptance criteria.

Here's a breakdown of what can be inferred or directly stated from the provided document, even if it doesn't align with an AI/ML device's typical performance study criteria:

Acceptance Criteria and Study for Persona® Personalized Knee System (Hardware Modification):

Based on the provided FDA 510(k) summary, the device is a knee prosthesis, and the submission is for the addition of new components (Ti-Nidium cruciate retaining (CR) femoral components). The regulatory pathway chosen is substantial equivalence to existing predicate devices. This means that instead of defining novel performance acceptance criteria for a new type of device or AI/ML algorithm, the manufacturer needed to demonstrate that the modified device is as safe and effective as existing legally marketed devices, primarily through non-clinical (bench) testing.

The "acceptance criteria" here are implied by the successful completion of these non-clinical tests to demonstrate that the new component does not negatively impact the established safety and efficacy of the overall system when compared to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. For bench testing, sample sizes are typically determined by statistical power calculations or industry standards for the specific test (e.g., n=3 or n=5 for certain mechanical tests, or a larger number for wear tests).
• Data Provenance: The tests are "Non-Clinical Tests," meaning they were performed in a lab setting (benchtop testing), likely by the manufacturer (Zimmer, Inc.). There is no mention of country of origin for data as it's not patient data.
• Retrospective or Prospective: Not applicable, as this refers to patient data collection.

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

• Not Applicable: This type of information (experts establishing ground truth) is relevant for studies involving qualitative assessments, diagnostic accuracy, or clinical endpoints adjudicated by medical professionals (e.g., radiologists, pathologists). For a knee prosthesis hardware modification, the "ground truth" is established by adherence to engineering specifications, material properties, and performance against established mechanical or sterility standards as measured by laboratory equipment.

4. Adjudication Method for the Test Set

• Not Applicable: Similar to point 3, adjudication methods are used to resolve disagreements among human reviewers (e.g., in reading medical images). Bench test results are quantitative measurements, not subject to human adjudication in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: The document explicitly states: "Clinical data was not deemed necessary for the subject device." Therefore, no MRMC study (which involves human readers/clinicians) was conducted or provided for this submission. The effect size of human readers improving with AI assistance is not relevant here as the device is a hardware implant, not an AI system.

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

• Not Applicable: This device is a physical knee prosthesis, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for non-clinical tests is based on established engineering and materials science principles and validated test methods (e.g., ISO standards, internal validated methods). For example, a fatigue test's "ground truth" is whether the component fractured after a certain number of cycles, compared to a predefined acceptance limit. For the Bacterial Endotoxin Test, the ground truth is the measured Endotoxin Units per device staying below a specified limit.

8. The Sample Size for the Training Set

• Not Applicable: This refers to machine learning models. The Persona® Personalized Knee System is a medical device hardware.

9. How the Ground Truth for the Training Set was Established

• Not Applicable: This refers to machine learning models.

In summary, the provided document is a 510(k) clearance letter for a hardware modification to a knee prosthesis. The regulatory path chosen (510(k) based on substantial equivalence) and the type of data presented (non-clinical bench testing) are entirely different from the robust clinical and AI/ML performance studies that would require the detailed information you requested about acceptance criteria, human experts, and large datasets for training and testing AI algorithms.

Ask a specific question about this device