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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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ATTUNE™ Revision Knee System: Candidates for total knee replacement include patients with A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatod arthritis Moderate valgus, varus, or flexion deformities Avascular necrosis of the femoral condyle A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with: Absence or loss of both cruciate ligaments Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon Bone loss that requires supplemental fixation in the clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cementless applications. ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.

DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only. The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives. THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM. THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM.

S-ROM™ NOILESTM Rotating Hinge Knee: The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions: 1. Severe instability, gross deformity and/or bone loss. 2. Failure of a previous knee reconstruction procedure. 3. Trauma or tumor resection. 4. Absent or markedly insufficient collateral ligaments.

DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for cement use only.

ATTUNE™ Revision Knee System: A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design Total knee arthroplasty may include supplemental fixation through stems, sleeves, and/or modular augments where bone loss requires said fixation in the opinion of the surgeon. Total knee arthroplasty may also include more constrained bearing surfaces where necessary to provide stability where musculoligamentous supporting structures are insufficient.

DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves: A Total Knee Prosthesis System is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges. The patella component may be of an all polyethylene design or may be a metal backed polyethylene component. The wobble bit is an instrument used to aid implant assembly.

DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components: A SIGMA™ Total Knee System is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant, with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial tray with or without porous coating, and a polyethylene insert and locking components. Some metal components have modular stems, sleeves and/or modular wedges or augments. The patella component is an all polyethylene design.

S-ROM™ NOILESTM Rotating Hinge Knee System: The S-ROM NOILES Rotating Hinge Knee System is a tricompartmental total knee replacement for both primary and revision cases. The S-ROM NOILES Rotating Hinge Knee System includes the femoral component with hinge pin, the tibial plateau assembly, and the distal femoral augmentation blocks. Replacement bumpers for the femoral component assembly and replacement hinge bearings for the tibial plateau assembly are also available.

DePuy P.F.C. TM SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis: The DePuy SIGMA™ and P.F.C.™ SIGMA® Total Knee Prosthesis is a total knee prosthesis composed of individually packaged femoral, tibial base, tibial insert and patellar components designed to replace the natural articular surface of the knee joint or after a failed previous implant. Some femoral and tibial components can be used with modular stems, porous and non-porous coated sleeves and/or modular augments when supplemental fixation is required in the judgement of the surgeon. The natural patella may or may not be resurfaced.

The provided text describes several knee prosthesis systems from DePuy, specifically outlining their intended use, indications for use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The devices in this application (ATTUNE™ Revision Knee System, DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves, DePuy Sigma PS Femoral Components, DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components, S-ROM™ NOILES™ Rotating Hinge Knee System, DePuy P.F.C.™ SIGMA™ Total Knee Prosthesis, DePuy SIGMA™ Total Knee Prosthesis) are being submitted with a modification to labeling to include updated MRI compatibility information and modernized/standardized language in the Instructions for Use (IFU) and labels. There are no changes in design, manufacturing, principle of operation, indication, or intended use of the devices themselves. Therefore, the "acceptance criteria" and "reported device performance" in this context relate to Magnetic Resonance (MR) Safety standards.

2. Sample size used for the test set and the data provenance:

The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The "tests" mentioned are non-clinical (bench testing) and refer to compliance with ASTM standards for MR safety and ANSI/AAMI for bacterial endotoxin. The document does not provide specific sample sizes for these non-clinical tests or their data provenance (e.g., country of origin, retrospective/prospective). It merely states that the tests were performed according to the specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as "No clinical tests were conducted." The ground truth for this submission is established through compliance with recognized industry standards for MR safety and bacterial endotoxin testing, not through expert-reviewed clinical data.

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

This is not applicable as "No clinical tests were conducted." The assessment is based on the results of non-clinical, standard laboratory tests.

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:

This is not applicable. The submission is for knee joint prostheses and concerns MR safety labeling, not an AI-assisted diagnostic or treatment system.

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

This is not applicable. The submission does not involve an algorithm or AI.

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

The "ground truth" for this submission is the compliance with established international and national standards for medical device safety, specifically:

• ASTM standards for Magnetic Resonance (MR) Environment safety (F2503-23, F2182-19E2, F2052-21, F2213-17, F2119-07).
• ANSI/AAMI ST 72:2019 for bacterial endotoxin testing.

8. The sample size for the training set:

This is not applicable as "No clinical tests were conducted." There is no "training set" in the context of this submission, which relies on non-clinical engineering and biological safety testing against established standards.

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

This is not applicable, as explained in point 8.

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The CPM Medical Consultants Tibial Revision Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthrius, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.

The CPM Medical Consultants Tibial Revision Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.

The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783.

The CPM Medical Consultants Tibial Revision Knee System is an extended design of The Modal Manufacturing Total Knee System (K142649/K150783). It is a cobalt-chromium-molybdenum (Co-Cr-Mo) metallic baseplate with a variety of components including tibial augments, stems, and offset adapters that provide more choice for surgeon treatment of their patients. The CPM Medical Consultants posterior stabilized plus inserts is a line extension to the previously cleared Modal Manufacturing posterior stabilized tibial insert (K142649). The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the previously cleared Modal Manufacturing Total Knee System (K142649/K150783) which is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Progressive Orthopaedic Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotation.

This document is a 510(k) summary for a medical device called the "CPM Medical Consultants Tibial Revision Knee System". It's a submission to the FDA to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices, meaning it's safe and effective for its intended use. Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum fatigue cycles, maximum stress values) for comparison. Instead, it refers to the performance of the predicate device as demonstrating substantial equivalence for the subject device. The reported device performance is that the testing confirms the components exhibit "appropriate mechanical characteristics" and are "substantially equivalent" to the predicate devices.

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

The document does not specify sample sizes for the performance tests conducted on the predicate devices. It states "Extensive preclinical testing was performed on the predicate devices per K142649 and K150783."

Data provenance (country of origin, retrospective/prospective) is not mentioned. Given that this is a 510(k) summary for a revision knee system, the testing is typically bench testing, not clinical trials with human subjects.

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)

This information is not applicable to this type of submission. The performance testing described is mechanical bench testing, not an evaluation that requires expert medical opinion to establish "ground truth."

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

Not applicable. The tests are physical and mechanical, not subject to human adjudication as would be the case in an image-based diagnostic study.

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 is not a study involving human readers or AI assistance. It's a submission for a mechanical implant.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for mechanical performance in this context would be the established engineering standards and specifications for orthopedic implants, which the predicate device demonstrated compliance with.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used.

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

Not applicable.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

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

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

• Moderate valgus, varus, or flexion deformities.

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

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

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

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

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

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

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

The provided text only briefly mentions that:

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

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

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

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

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint confi guration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and fibial augment components are indicated for cemented use only.

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

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

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

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

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

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

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

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

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

It does NOT contain information about:

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

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

Therefore, your request, which is structured around the evaluation of an AI or algorithm-based medical device, cannot be answered using the provided text, as the text describes a hardware medical implant, not a software device.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

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

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

• Moderate valgus, varus, or flexion deformities.

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

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

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

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

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

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Revision Tibia Baseplates offer enhanced torsional stability by adding keels to the posterior end of the device. This design is similar to keeled stem designs currently marketed.
The retaining bolt modifications offer additional bolt sizes that allow the cleared tibial inserts to lock into the proposed longer Revision tibial Baseplate.
The material of the proposed Revision Tibial Baseplate is Cobalt Chrome, CoCr (ASTM F75). The material if the proposed retaining bolts is Ti-6Al-4V E.L.I (ASTM F136)

This document describes the regulatory submission for the Apex Revision Knee System (K163332), a medical device. The information provided heavily emphasizes substantial equivalence to a predicate device (K153437) rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in a traditional sense (e.g., performance metrics, statistical analysis).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) or a study with reported performance values. Instead, the basis for approval is "substantial equivalence" to a predicate device.

The study presented is a justification of substantial equivalence, not a performance study against specific acceptance criteria. The "reported device performance" is essentially that it is considered "as safe, as effective, and performs as well as or better than the legally marketed predicate."

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

• Sample Size: Not applicable in the traditional sense of a clinical or performance study with a test set of data. The "test set" here refers to the new proposed components and their interaction with existing components.
• Data Provenance: Not applicable. The "study" is a series of justifications and evaluations rather than a data-driven test.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned, as this was not a study involving human interpretation or subjective assessment.

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

• MRMC Study: No. This device is a mechanical knee prosthesis, not an AI-assisted diagnostic tool.

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

• Standalone Performance: No. This device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (K153437). The new device is deemed equivalent because its modifications do not introduce new risks. The justifications listed are:

• "KTR-116 Tray Fatigue FEA" (Finite Element Analysis) - This indicates an engineering simulation was performed for fatigue, but the results or a direct comparison to acceptance criteria are not provided in this summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not a machine learning model.

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

• Ground Truth Establishment: Not applicable.

Summary of Device Acceptance and Study:

The acceptance of the Apex Revision Knee System (K163332) is based on the demonstration of substantial equivalence to a previously cleared predicate device (K153437). The "study" is less of a traditional performance study and more of a technical justification.

Acceptance Criteria (Implied by Substantial Equivalence):

Key takeaways from the document regarding the "study":

• This was a Special 510(k) submission, used when modifications to a legally marketed device do not significantly alter its safety or effectiveness.
• The manufacturer explicitly states that "Testing was not conducted" in a hands-on sense for comparing the new device against the predicate. Instead, "justifications were written" and the devices were "evaluated."
• The primary justification is that the modifications (additional baseplate and retaining bolt types) maintain the "basic design, interface, fundamental technology, materials and intended use" of the cleared predicate device.
• The listed "study" is "KTR-116 Tray Fatigue FEA", which is a Finite Element Analysis for fatigue. This is a computational simulation, not a physical study with a test set of real-world data or human subjects. The details of the FEA results or acceptance criteria for fatigue are not included in this summary document.
• The "ground truth" for demonstrating equivalence is the established safety and effectiveness profile of the predicate device (K153437).

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Candidates for total knee replacement include patients with:

• A severely painful and/or severely disabled joint resulting from osteoarthritis, post-● traumatic arthritis, or rheumatoid arthritis
• Moderate valgus, varus, or flexion deformities
• Avascular necrosis of the femoral condyle
• A previous unsuccessful knee replacement, osteotomy, or other knee procedure ●

ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:

• Absence or loss of both cruciate ligaments ●
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased ● constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Any non porous-coated components are intended for cemented use only.

The ATTUNE® Revision Knee System is a total knee replacement prosthesis consisting of various components including ATTUNE REVISION CRS FEMORAL COMPONENTS, ATTUNE REVISION CRS FIXED BEARING INSERTS, ATTUNE REVISION FIXED BEARING TIBIAL BASES, ATTUNE REVISION STEMS, ATTUNE REVISION FEMORAL SLEEVES, ATTUNE REVISION FEMORAL AUGMENTS, ATTUNE REVISION TIBIAL AUGMENTS, and ATTUNE REVISION OFFSET ADAPTOR. These components are made from materials such as cast Co-Cr-Mo alloy, UHMWPE, and Ti-6Al-4V ELI alloy. The system is designed for use in total knee arthroplasty to replace the damaged knee joint articulation.

The provided document is a 510(k) Premarket Notification for a medical device, the ATTUNE® Revision Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets clinical acceptance criteria through a formal clinical study with ground truth and expert consensus. The FDA document explicitly states, “Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Revision Knee System and the predicate devices.”

Therefore, the requested information regarding acceptance criteria, study data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document.

The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. Below is a summary of the non-clinical performance information provided.

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

The document describes functional testing performed in compliance with FDA Guidance for Knee Joint Prostheses. While explicit numerical acceptance criteria values are not provided, the general statement below indicates that the measured performance met the necessary thresholds.

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 refers to non-clinical, in-vitro mechanical and material testing, not human-subject testing involving datasets.

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 based on expert review was established in this submission.

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. No MRMC comparative effectiveness study was performed or required for this device.

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

Not applicable. This is a knee implant, not an AI/algorithm device.

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

Not applicable. The "ground truth" in this context is adherence to established engineering standards (ASTM F75, F136, F648, F620, F1537, F799, ANSI AAMI ST-72:2011) and FDA Guidance for mechanical performance testing for knee prostheses.

8. The sample size for the training set:

Not applicable. No training set for an algorithm was used.

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

Not applicable.

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity:
• · Revision procedures where other treatments or devices have failed;

The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.

The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement.

The fluted femoral stems and the keeled femoral stems are slight modifications of the existing designs. The femoral stems offer enhanced press-fit implantation and torsional stability by adding longitudinal raised ribs similar to most stems designs currently marketed.

The notched 10mm posterior femoral augment has been created to increase the product offerings when using posterior augments. The new notched augment will allow a 10mm distal augment and 10mm posterior augment to be used together.

The femoral Locking Bolt functions similarly to the tibial locking bolt. It was designed for femoral use for enhanced fixation of the stem to the femur.

The current tibial peg offers additional torsional stability when added to the modular tibial baseplate. The proposed revision tibial Peg is a slight modification of that existing tibial peg and is improved in size and torque strength. The Augment Peg Bolt is similar to the tibial peg and can be used to add additional torsional stability to the modular tibia baseplate when augments are used.

The material of each new component is titanium alloy Ti-6Al-4V E.L.I (ASTM F136)

The provided document is a 510(k) premarket notification for a medical device called the "Apex Revision Knee System." It details the device's indications for use, its description, and the manufacturer's assertion of substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for artificial intelligence (AI) or software-based medical devices.

This 510(k) is for a physical medical device (a knee prosthesis), not a diagnostic AI system or a decision support software. The "study" referenced in the document (KTR-102 Femur Stem Bolt Testing Justification, KTR-100 Revision Knee Fluted Stem FEA Comparison, etc.) are engineering justifications and comparisons to existing predicate devices, primarily through finite element analysis (FEA) and design comparisons, not clinical trials or performance assessments against specific numerical acceptance criteria for an AI system.

Therefore, I cannot fulfill your request for the tables and study details related to AI device performance based on the provided text. The information you are seeking (AI acceptance criteria, human reader improvement with AI, ground truth establishment, sample sizes for training/test sets, expert qualifications, etc.) is simply not present in this type of regulatory submission for a physical orthopedic implant.

If you have a document describing an AI medical device, please provide that, and I would be happy to assist with your request.

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