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Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

• Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
• Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR).
• Acute traumatic fracture of the femoral head or neck.
• Avascular necrosis of the femoral head.

Z1 Hip System is for cementless use only.

The Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation in the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region and the taper, the entire surface of the stem is grit-blasted, proximally sprayed with a Ti-6Al-4V titanium alloy plasma coating, and followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in standard, high offset, and coxa vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The stems are compatible with previously cleared Zimmer Biomet modular femoral heads and/or acetabular components.

The provided text is an FDA 510(k) clearance letter for the Z1 Hip System, which is a medical device for hip arthroplasty. The document details the administrative aspects of the clearance, the device description, intended use, and a summary of non-clinical testing.

However, the question asks for information related to a "study that proves the device meets the acceptance criteria," specifically in the context of an AI/Software as a Medical Device (SaMD). The Z1 Hip System is a physical orthopedic implant, not an AI/SaMD. The document clearly states:

• "No clinical testing was conducted." (Page 6)
• The tests performed are "Distal Fatigue Testing per ISO 7206-4", "Proximal Fatigue Testing per ISO 7206-6", "Evaluation of Compatibility with Femoral Heads", and "Evaluation of Range of Motion" (Page 6). These are all mechanical and performance tests for a physical implant, not studies involving AI algorithms, expert reads, or clinical outcomes data as would be relevant for an AI/SaMD.

Therefore, I cannot provide the requested information as the provided text does not contain any details about acceptance criteria or a study design relevant to an AI/SaMD. The information requested (multi-reader multi-case studies, ground truth establishment, sample size for training sets, etc.) is specific to the validation of AI algorithms, which is not applicable to the Z1 Hip System described in this 510(k) clearance.

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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 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 purpose of this submission is to add a new component to the Persona Revision Knee System, the component is the Persona Revision SoluTion Femoral Components. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The Persona Revision Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones. With this submission a new Ti-6Al-4V femoral component will be added to the system. These femoral components articulate against an articular surface of the tibial component, as well as, a pat of a total knee system. The new femoral components are compatible with a variety of augments, cones, and stem extent of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

This document is a 510(k) Premarket Notification from the FDA regarding the "Persona® Revision Knee System (Persona Revision Solution™ Femoral Components)." It does not contain acceptance criteria for a study, nor does it present the results of a study to demonstrate that a device meets such criteria.

Instead, this document is a notification of the FDA's decision that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a review of information provided by the manufacturer, Zimmer, Inc., which includes a summary of non-clinical tests performed.

The relevant section, "Non-Clinical and/or Clinical Tests Summary & Conclusions" on page 5, lists several non-clinical tests that were performed (e.g., fatigue evaluations, wear evaluation, constraint assessment, augment shear and torque, stem junction fatigue, stem static axial pull-off and torque-off, RF-induced heating simulations, fretting corrosion assessment).

However, for each of these tests, the document only lists the test name. It does not provide:

• Acceptance criteria: What performance metrics were deemed acceptable for each test.
• Reported device performance: The actual results obtained from these tests.
• Study details: Such as sample sizes, data provenance, ground truth establishment, or any information related to expert involvement (for clinical studies, which are explicitly stated as "Not Applicable" here).
• Comparative effectiveness study (MRMC) or standalone performance: These are not discussed as the tests are non-clinical.

In summary, the provided document explicitly states "Clinical Testing Not Applicable" and lists non-clinical tests without presenting their results or acceptance criteria. Therefore, it is not possible to provide the requested information.

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Anatomic Total Shoulder Applications:

· Osteoarthritis

• The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.

OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications.

Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement.

Compatible Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

The OsseoFit™ Stemless Shoulder System consists of a stemless humeral head adapter for anatomic total shoulder applications. The OsseoFit humeral implant is an anatomical (left/right specific), asymmetric humeral anchor with six fins whose location, length, and height vary. The OsseoFit humeral implants are available in Onlay and Inlay variants. The Onlay implants sit on top of the prepared bone while the Inlay implants have a dished superior portion with a shorter fin length to sit within the bone. The OsseoFit Humeral Implant also includes anterior suture holes for soft tissue attachment.

The humeral implants are manufactured through additive manufacturing which includes areas of OsseoTi porous technology to allow biological fixation.

The OsseoFit Stemless Shoulder System is intended for cementless applications and is designed to be used with a compatible Identity Shoulder System (K213856) humeral head. The Identity Humeral Head is assembled to the OsseoFit Humeral Head Adapter via a locking taper by a disposable impactor that is packaged together with the head adapter. The Identity heads can be used with a compatible Alliance Glenoid Implant (K191814 and K193180) or Comprehensive Convertible Baseplate liner (K211729).

The provided text describes the regulatory filing for the OsseoFit Stemless Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing.

However, the document does not contain any information about a study that assesses the device's performance against specific acceptance criteria in terms of algorithm or diagnostic accuracy, or human reader improvement with AI assistance. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Tests: None Provided." The non-clinical tests listed are related to the mechanical and material properties of the device (e.g., fatigue testing, micromotion testing, MRI compatibility, porous coating characterization, manufacturing validation), not to an AI component or a diagnostic performance study.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and the reported device performance: This information is not present as there's no mention of a performance study in the context of diagnostic accuracy or AI.
2. Sample size used for the test set and the data provenance: No such test set or data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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: The document clearly states "Clinical Tests: None Provided." There is no mention of an AI component or human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No algorithm or standalone performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in this context.
8. The sample size for the training set: Not applicable as there's no mention of an AI model or training.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical implant, focusing on its mechanical, material, and design characteristics relative to predicate devices. It does not contain information about studies measuring diagnostic performance, AI performance, or human reader effectiveness with AI assistance.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.

• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

• Moderate valgus, varus, or flexion deformities.

• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

When a Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.

• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-Peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

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

The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. With this submission a new porous coated Ti-6Al-4V femoral component will be added to the system. These femoral components articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The new femoral come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

The provided text describes the regulatory clearance for the Persona Ti-Nidium PPS Femurs, a component of the Personalized Knee System, but it does not contain the specific details required to answer your questions about acceptance criteria and study design.

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

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

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

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

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

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 Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona Osseo Ti Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add compatibility of the Persona OsseoTi 3-Peg Patella to the Persona® the Personalized Knee System Posterior Stabilized (PS) femoral components. The addition of this compatibility does not change the intended use or fundamental scientific technology of the device system.

The Persona® the Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patella bones. With this submission compatibility of the Persona OsseoTi 3-Peg patella components will be added to the Persona PS femoral components of the knee system. These patella components articulate against femoral component as part of a total knee system. These patellar components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

The provided text is a 510(k) summary for the "Persona the Personalized Knee System." It details the device's indications for use, technological characteristics, and comparison to predicate devices, focusing on the added compatibility of the Persona OsseoTi 3-Peg Patella with Posterior Stabilized (PS) femoral components.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an algorithm or AI performance. The tests mentioned are non-clinical durability tests for mechanical components of a knee prosthesis, performed according to ISO standards. These are physical tests, not studies evaluating software or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device being described.

Here's what can be extracted based on the provided text, while acknowledging that the primary request is not fully addressable due to the nature of the device:

1. A table of acceptance criteria and the reported device performance:

Since the device is a knee prosthesis and not an AI/software device, the "acceptance criteria" and "reported device performance" are related to mechanical durability rather than algorithmic accuracy. The document states that durability testing was performed "per ISO 14243-5." This ISO standard would inherently define the acceptance criteria (e.g., number of cycles without failure, wear rates within limits). However, the specific quantitative acceptance criteria and the detailed qualitative or quantitative performance results (e.g., actual wear rates, exact number of cycles completed by the device in the test without failure) are not reported in this summary. It only states that the tests were done.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable in the context of an AI/software test set. For the mechanical durability tests, the "sample size" would refer to the number of prostheses tested. This is not explicitly stated in the provided text.
• Data Provenance: Not applicable in the context of clinical data for AI. These are non-clinical mechanical tests, likely performed in a lab setting by the manufacturer (Zimmer, Inc., based in Warsaw, Indiana, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. Ground truth, in the context of experts interpreting data, is relevant for AI/software evaluations. For mechanical durability testing, the "ground truth" is determined by the physical outcome of the test (e.g., whether a component fractured, or wear measurements). This doesn't involve human experts establishing a ground truth in the interpretative sense.

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

Not applicable. Adjudication methods are used to resolve disagreements among multiple human readers/experts in AI/software evaluations. This is a non-clinical mechanical test.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document does not mention any MRMC study. The device is a physical knee prosthesis, not an AI or software product intended to assist human readers.

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

No. This is not an algorithm.

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

Not applicable in the AI/software sense. For mechanical tests, the "ground truth" is the physical measurement or observation of the component's state after rigorous testing (e.g., did it fail, what was the wear rate).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a premarket notification for a physical medical device (knee prosthesis) and its mechanical testing. It does not pertain to an AI/software device, therefore, almost all the specific questions about acceptance criteria and studies for AI performance cannot be answered from this text.

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 Personalized Alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented (biological fixation), except for the Persona OsseoTi Keel Tibia and the Persona OsseoTi 3-peg Patella which are for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

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

The Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral, tibial, and patellar bones. With this submission a new porous metal backed UHMWPE patella component will be added to the system. These patellar components articulate against femoral component as part of a total knee system. The new patellar components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use. To aid the implantation of these devices several new reusable instruments are also introduced.

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

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

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

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

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

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

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

The conclusion drawn by the applicant is that:

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

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

Ask a specific question about this device

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

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 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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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
5. Revision procedures where other treatment or devices have failed

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

Indications for G7® Vivacit-E® Freedom® Constrained Liner:

The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.

The provided text describes the 510(k) submission for the G7® Vivacit-E® Freedom® Constrained Liner, a medical device for total hip arthroplasty. The document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device approval in the United States. This involves comparing the new device's characteristics and performance to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• No acceptance criteria for an AI/ML device are described. The document pertains to a physical orthopedic implant, not a diagnostic AI/ML software. Acceptance criteria for mechanical implant devices typically involve benchmarks for physical properties, wear, and mechanical strength, which are mentioned in the "Summary of Performance Data," but these are not the type of diagnostic performance metrics expected for an AI/ML device.
• No study proving diagnostic performance is detailed. The studies listed are engineering performance tests for a physical implant (e.g., insertion energy, torque out, wear testing, fatigue testing, range of motion), not studies to assess diagnostic accuracy, sensitivity, or specificity of an AI/ML algorithm.
• No information on ground truth, expert consensus, or training/test sets for an AI/ML model is present. These concepts are not applicable to the type of device described in the document.

In summary, the provided document does not align with the request to describe acceptance criteria and a study for an AI/ML diagnostic device. It describes a traditional medical device (a hip implant component) and its substantial equivalence submission to the FDA.

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