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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 confi guration, 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 components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augments are indicated for cemented use only.

The purpose of this submission is to obtain clearance for the changes/proposed changes made to the Persona Revision Knee System femoral metaphyseal cones post their original 510(k) submission/clearance. The Persona Revision Knee System femoral metaphyseal cones are intended to fill distal femoral cavitary bone defects during knee arthroplasty.

This FDA document is a 510(k) clearance letter for the Persona® Revision Knee System Femoral Metaphyseal Cones. It confirms that the device is substantially equivalent to a previously cleared predicate device.

The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the way you've outlined for an AI/ML medical device. This is because the Persona Revision Knee System Femoral Metaphyseal Cones are a mechanical orthopedic implant, not an AI/ML imaging or diagnostic device.

For a mechanical device like this, "acceptance criteria" and "performance studies" are typically related to:

• Biocompatibility: Ensuring the materials are safe for implantation.
• Mechanical Testing: Verifying the strength, fatigue life, and wear characteristics of the implant components under simulated physiological loads. This often involves standardized tests (e.g., ISO standards) and sometimes finite element analysis (FEA).
• Sterilization Validation: Confirming the chosen sterilization method is effective.
• Design Verification and Validation: Ensuring the device meets its design specifications and user needs.

The provided text only briefly mentions that:

• Finite Element Analysis (FEA) was used to predict peak stress under physiological loading. This is a common non-clinical method for evaluating the mechanical performance of orthopedic implants.

Therefore, I cannot populate your requested table and information points as they are designed for AI/ML device evaluations, and this document pertains to a traditional mechanical medical device.

Here's why each of your requested points cannot be answered from the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable for an AI/ML device; for this mechanical device, specific mechanical test results and acceptance criteria are not detailed in this summary document.
2. Sample size for test set and data provenance: No test set of data (like images or patient records) for an algorithm is mentioned.
3. Number of experts and qualifications for ground truth: No ground truth established by experts for algorithmic performance is relevant here.
4. Adjudication method: Not applicable as there's no diagnostic output to adjudicate.
5. MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic tool.
6. Standalone performance: Not applicable, as there is no algorithm that performs independently.
7. Type of ground truth: Not applicable, as there's no diagnostic task involving ground truth.
8. Sample size for training set: Not applicable, as there is no AI algorithm to train.
9. How ground truth for training set was established: Not applicable.

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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 confi guration, 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 components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and fibial augment components are indicated for cemented use only.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:

• Femoral components
• Articular surfaces
• Tibial components
• . Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones
  The large modularity of the componentry of the Persona Revision Knee System including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
  The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

The provided text is an FDA 510(k) clearance letter for the Persona Revision Knee System. It does not contain any information about acceptance criteria, device performance studies, or AI/human reader studies.

The document states that the purpose of the submission is to obtain clearance for "proposed changes to the contraindications for the Persona Revision Knee System" to align with current standard practice and for clarification. Crucially, it explicitly mentions: "Non-clinical or clinical tests are not needed to support the proposed changes to contraindications."

Therefore, I cannot fulfill your request to describe acceptance criteria and study details as this information is not present in the provided text. The document is about a modification to labeling (contraindications) for an already cleared device, not about a study proving new performance claims.

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 components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:

• Femoral components
• Articular surfaces
• Tibial components
• Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones.
  The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
  The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

I'm sorry, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

The provided text is an FDA 510(k) clearance letter for a Persona Revision Knee System, which is a medical device (a knee prosthesis). This document primarily focuses on the regulatory clearance process, stating that the device is "substantially equivalent" to legally marketed predicate devices.

It does NOT contain information about:

• Specific acceptance criteria metrics (e.g., in terms of sensitivity, specificity, accuracy for an AI/algorithm-based device).
• Detailed performance study results for an AI/algorithm-based device.
• Sample sizes for test sets or training sets in the context of an AI/algorithm.
• Information about expert consensus, ground truth establishment methods, multi-reader multi-case studies, or standalone algorithm performance.

The document mentions "Non-Clinical Tests" and "Clinical Tests" but these refer to mechanical and sterility testing of the knee implant and associated instruments, not to the performance evaluation of an AI or algorithmic medical device. For example, "Stem housing cantilever fatigue" and "Cadaveric design validation" are relevant to a physical medical implant, not a software algorithm. The document explicitly states, "Clinical data was not deemed necessary for the subject device," further indicating that a a large-scale clinical performance study (as would be typical for an AI/ML device) was not conducted or required for this particular type of device clearance.

Therefore, your request, which is structured around the evaluation of an AI or algorithm-based medical device, cannot be answered using the provided text, as the text describes a hardware medical implant, not a software 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 components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:
• Femoral components
• Articular surfaces
• Tibial components
• Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones
The large modularity of the componentry of the Persona Revision knee system including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.

This FDA 510(k) summary for the "Persona Revision Knee System" does not describe a study involving an AI/ML device or its performance criteria. It pertains to a physical medical device (a knee prosthesis) and the tests conducted are primarily mechanical and material property assessments, not related to AI/ML performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving an AI/ML device meets them from the provided text. The document focuses on showing substantial equivalence of a knee implant to existing devices through non-clinical (mechanical, material, design) testing and intended use comparisons.

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