Search Results
Found 9 results
510(k) Data Aggregation
(30 days)
Persona Personalized Knee System
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 or uncemented (biological fixation), except for the Persona Osseo Ti Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMVPE and VEHXPE) patella components are indicated for cemented use only.
The purpose of this submission is to add the Personalized Alignment surgical technique indication to the Persona Personalized Knee System
The provided text is a 510(k) summary for the Zimmer® Persona® Personalized Knee System, which is a knee prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a device meets specific acceptance criteria for performance as one might expect for a digital health or AI device.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is largely not applicable in the context of this 510(k) submission.
Here's why and what can be extracted:
- Acceptance Criteria & Reported Performance: This document does not describe specific performance-based acceptance criteria for the device itself (e.g., accuracy, sensitivity, specificity, or surgical outcome percentages). Instead, it relies on demonstrating that the new indication (Personalized Alignment surgical technique) is substantially equivalent in terms of safety and effectiveness to existing predicate devices.
- Study That Proves the Device Meets Acceptance Criteria: No clinical study demonstrating performance against acceptance criteria in the traditional sense is described. The "performance data" section explicitly states "Non-Clinical Tests" and "Clinical Tests: None provided."
- Algorithm/AI Context: The Persona™ Personalized Knee System is a physical medical device (knee prosthesis), not an AI-powered diagnostic or therapeutic software. Therefore, concepts like "test set," "training set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance" are not relevant to this type of device submission.
Summary of Extracted Information based on the provided text's context:
Since the provided text is for a physical medical device (knee prosthesis) seeking 510(k) clearance based on substantial equivalence, the questions regarding acceptance criteria, study design, sample sizes, ground truth, experts, and AI analysis are generally not applicable. The submission focuses on comparing the new use of the device to existing predicate devices.
What can be inferred or directly stated from the text:
- Device Type: Zimmer® Persona® Personalized Knee System (Knee Prosthesis)
- Purpose of Submission: To add the "Personalized Alignment surgical technique indication" to the existing Persona Personalized Knee System.
- Basis for Clearance: Substantial Equivalence to predicate devices (K113369, K172524, K221479).
- Rationale for Substantial Equivalence: Based on identical/similar characteristics:
- Intended Use: Identical
- Indications for Use: Similar (expanded with Personalized Alignment)
- Materials: Identical
- Design Features: Identical
- Sterilization: Identical
- Non-Clinical Tests Performed:
- Persona® 0° Keel Tibial and Persona® PPS® Femur Design Validation - Device Comparison.
- Persona 0° Tibia Keel and Peg Perforation Personalized Alignment.
- Clinical Tests: None provided.
- Ground Truth: Not applicable in the context of this submission. The "ground truth" for a physical device is its physical properties and mechanical performance as demonstrated through non-clinical testing and comparison to predicates.
If this were a submission for an AI/digital health product, the information would be very different.
Ask a specific question about this device
(178 days)
Persona Personalized Knee System
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.
Ask a specific question about this device
(54 days)
Zimmer Persona Personalized Knee System
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:
- Shelf life extension of the Vivacit-E polyethylene components after ethylene oxide re-sterilization.
- 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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(56 days)
Persona Personalized Knee System
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
(63 days)
Persona Personalized Knee System
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
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Durability/Integrity: | "Performance data and analyses demonstrate that: any differences 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 devices." (General conclusion) |
| - Intercondylar (IC) notch deformation (Internal test method) | Not explicitly detailed, but presumably met internal standards to ensure structural integrity and prevent deformation. |
| - Posterior condyle fatigue (Internal test method) | Not explicitly detailed, but presumably met internal standards to ensure resistance to repeated stress. |
| Biocompatibility/Wear Performance: | |
| - Ti-Nidium femoral induced wear of ultra-high molecular weight polyethylene (UHMWPE) articular surfaces (per ISO 14243-3) | Not explicitly detailed, but the test was performed to assess adverse wear effects. Conclusion implies acceptable wear. |
| - Assessment of wear due to 3rd body particles during articulation | Not explicitly detailed, but the test was performed to assess resilience to wear in the presence of contaminants. Conclusion implies acceptable wear. |
| Imaging Compatibility: | |
| - Evaluation of the Persona Ti-Nidium Femur Components in the Magnetic Resonance Imaging (MRI) Environment | Not explicitly detailed, but presumably showed acceptable MRI compatibility (e.g., minimal artifact). |
| Sterility/Endotoxin Levels: | |
| - Bacterial Endotoxin Test (BET) per ANSI/AAMI ST 72:2011, demonstrating implants meet the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter Medical Devices - Bacterial Endotoxin and Pyrogen Tests | Met the specified limit of ≤20 EU/Device. |
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
(269 days)
Zimmer Persona Personalized Knee System
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.
Ask a specific question about this device
(90 days)
Zimmer Persona Personalized Knee System
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:
- Acceptance criteria or reported device performance for an AI/ML or diagnostic device.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- 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
(124 days)
Zimmer Persona Personalized Knee System
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
(87 days)
Zimmer Persona Personalized Knee System
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
| Test | Acceptance Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility testing of Ti-6Al-4V alloy with bonded Titanium Nitride. | Meet ISO 10993-1 requirements. | "This test demonstrated that the material utilized by the subject femoral components meet ISO 10993-1 requirements. Therefore, there are no biocompatibility concerns." |
| Wear testing of the subject femoral components with Persona articular surfaces. | Equivalent to the predicate device Persona system (per ISO 14243-3). | "This test, completed per ISO 14243-3, demonstrated that the wear characteristics of the subject femoral components with Persona articular surfaces are equivalent to the predicate device Persona system." |
| Evaluation of Interactions with the Magnetic Fields in the Magnetic Resonance Imaging (MRI) Environment. | Safety and compatibility within the MRI environment, under previously defined conditions for the predicate device. | "This analysis demonstrated safety and compatibility of the Persona knee system within the MRI environment. Therefore, the Persona system can be used under the same MRI conditions previously defined for the predicate device system." |
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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