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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 or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Zimmer Inc Persona Personalized Knee System offers Vivacit-E polyethylene components that are sterile packaged with a shelf life of 5 years. The purpose of this submission is to extend the shelf life of these polyethylene components by re-packaging and re-sterilizing unexpired product and product expired up to 3 months post-expiration date. The rework of these devices to extend the shelf life by an additional 5 years does not change the intended use or fundamental scientific technology of the device.

Based on the provided text, the submission is for extending the shelf life of an existing medical device, the Zimmer Persona Personalized Knee System. It is not a submission for a new AI/ML-driven medical device, and therefore, the document does not contain information about acceptance criteria or a study proving an AI/ML device meets those criteria.

The text focuses on non-clinical data related to:

1. Shelf life extension of the Vivacit-E polyethylene components after ethylene oxide re-sterilization.
2. Biological safety assessment of the re-sterilized components.

The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states that the listed items are "Non-Clinical Tests." There is no mention of a comparative effectiveness study involving human readers with and without AI assistance, or any standalone algorithm performance testing, or the use of experts to establish ground truth for a test set.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device meets those criteria, as the provided document pertains to a resubmission for a non-AI/ML device's shelf-life extension.

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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 or uncemented (biological fixation). All other femoral, tibial baseplate, stem extension, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The subject Persona Personalized Knee System components are identical to the predicate Persona Personalized Knee System components. Introduction of a kinematic alignment technique for use with the Persona Personalized Knee System CR and UC components does not change the intended use or the fundamental scientific technology of the associated implants.

The provided text is a 510(k) summary for the Zimmer® Persona® Personalized Knee System, focusing on the addition of a kinematic alignment surgical technique. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/medical device. Instead, it details the regulatory process for a knee replacement system.

Therefore, I cannot extract the requested information from the provided document. The document describes a traditional medical device (knee implant) rather than a software-as-a-medical-device (SaMD) or an AI-powered diagnostic device, which typically involves the kind of performance studies and acceptance criteria you've asked about (sensitivity, specificity, AUROC, etc.).

The "Summary of Performance Data" section lists non-clinical tests related to the mechanical performance of the knee system, not diagnostic accuracy or AI model performance.

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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 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 purpose of this submission is for a specification update to the Persona Trabecular Metal tibial component, as well as to introduce new tibial instrumentation unique to the device. These modifications do not change the intended use or fundamental scientific technology of the device.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a knee joint prosthesis (Zimmer® Persona® Personalized Knee System). It describes the device, its intended use, indications for use, and a summary of technological characteristics, stating that clinical data was not deemed necessary.

Therefore, there is no information in this document about:

1. Acceptance criteria or reported device performance for an AI/ML or diagnostic device.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

This document pertains to a medical device (knee implant), not a software or AI/ML product.

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 (biological fixation). All other femoral, tibial baseplate, 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. With this submission, Medial Congruent (MC) Vivacit-E® articular surface components are being added to the system. The subject components articulate against, the existing Cruciate Retaining (CR) femoral component, and lock onto the existing tibial baseplate components using a dovetail mechanism. The subject articular surface components, when used with the CR femoral, can accommodate a maximum active flexion of 155°. The MC articular surfaces provide greater medial conformity, similar anterior lateral conformity, and less posterior lateral conformity when compared to the predicate Persona UC articular surface design. In addition, the subject articular surface can be implanted with or without a functioning PCL. The components are single use and are provided sterile to the healthcare facility/hospital. MC articular surfaces are for use with both cemented and uncemented femoral and tibial baseplate components.

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer® Persona® Personalized Knee System. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.

However, the provided document does not contain information related to software or AI-driven medical devices. Therefore, it is not possible to describe acceptance criteria or a study proving that an AI-enhanced device meets those criteria based on this document.

The document discusses acceptance criteria and performance data for a physical medical device (a knee prosthesis), which involves mechanical and material properties rather than AI-related metrics like accuracy, sensitivity, or specificity.

Specifically, the document lists "Property or Characteristics" and "Analysis/Test Results" for the knee system, which include:

• Biocompatibility testing
• Evaluation of wear performance
• Tibiofemoral Constraint Evaluation
• Tibiofemoral Contact Area and Contact Pressure Evaluation
• Anterior and Posterior Liftoff Testing
• Evaluation of Interactions with Magnetic Fields (MRI compatibility)
• Posterior Crush Evaluation

These are all physical tests for a physical implant. The document explicitly states: "Clinical data and conclusions were not needed for this device." This further confirms that the assessment did not involve human-in-the-loop studies or standalone algorithm performance, as these would be relevant for software or AI.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study for an AI-driven device based on the provided text. The information requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, etc.) is specific to AI/software validation studies and is not present in this document.

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 (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 semi-constrained 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 F136-13) with a Titanium Nitride surface treatment are being added to the system (5050, 5056, 5070, 5076 femoral component families). These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. They are available in Cruciate Retaining (CR) and Posterior Stabilized (PS) designs. Both designs are 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. The PS and CR femoral components, when used with a PS or CR articular surface component, can accommodate a maximum active flexion of 155°. The CR femoral component, when used with an Ultra-Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. The PS femoral component, 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 to the healthcare facility/hospital.

The provided document is a 510(k) summary for the Zimmer® Persona® Personalized Knee System. It is a medical device submission to the FDA, and as such, it does not describe a study involving an AI algorithm or software. Instead, it describes non-clinical performance testing for a physical orthopedic implant.

Therefore, many of the requested fields related to AI algorithm performance evaluation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information regarding the acceptance criteria and study results for the physical device's performance, as outlined in the "Non-Clinical Performance and Conclusions" section.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI-specific questions, I must state that these are not applicable to the provided document as it concerns a physical orthopedic implant and its non-clinical performance testing.

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: This document describes non-clinical performance testing of a physical medical device, not an AI algorithm evaluated on a data set. The "test set" would refer to physical prototypes or materials tested.

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 expert consensus, is not relevant for the physical performance tests conducted for this device. Ground truth for these tests would be established by scientific measurement and adherence to standards.

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

• Not Applicable: Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant to the non-clinical physical testing 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 type of study is for evaluating AI in diagnostic contexts with human readers, which does not apply to a knee implant.

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

• Not Applicable: There is no AI algorithm discussed in this document.

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

• Analytical/Empirical Standards: For the physical device, the "ground truth" or reference for assessment relies on established international standards (ISO 10993-1 for biocompatibility, ISO 14243-3 for wear testing) and engineering analyses for MRI compatibility.

8. The sample size for the training set

• Not Applicable: There is no AI algorithm or training set discussed in this document.

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

• Not Applicable: There is no AI algorithm or training set discussed in this document.

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