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The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis,

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques.
  Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.

• · Severe anteroposterior instability of the knee joint.

The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

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

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

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 this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering 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

• No. This is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

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

• No. This is a physical knee implant, not an AI/ML algorithm.

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

• The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

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The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

The indications for use are:

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
• E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

The Consensus Knee System (CKS) modular tibial baseplate is a non-porous (uncoated), anatomic, fixed-bearing design made from cast CoCrMo (ASTM F75). Its boss-and-fin type keel employs a modular 12/14 female taper for assembly with Consensus Revision Knee System (RKS) stems or the RKS taper plug. The CKS modular baseplate is offered in pegged, pegless, and holed configurations. Holed configurations are supplied with preassembled cement dams manufactured from UHMWPE (ASTM F648). All configurations are supplied with a distal plug intended for assembly in the operating room when stems are not desired. Distal plugs are manufactured from UHMWPE (ASTM F648). Other components compatible with the CKS modular baseplate include all CKS tibial inserts, femoral components, and patella components; all RKS femoral components; and the 6.5mm cancellous bone screw used with CKS holed baseplates.

This document is a 510(k) premarket notification for the "Consensus Knee System Modular Tibial Baseplate." It demonstrates the device's substantial equivalence to previously marketed devices rather than providing a study demonstrating the device meets a set of acceptance criteria in the typical sense of a clinical trial for an AI/CAD product.

Therefore, the requested information elements related to AI/CAD system performance (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this regulatory submission.

However, I can extract the closest analogous information regarding the evaluation of this medical device.

1. A table of Acceptance Criteria and the Reported Device Performance:

The document describes non-clinical performance data (bench testing) to verify the device's safety and effectiveness. The "acceptance criteria" are implied by the standards used for testing (ASTM F1800-12) and the stated objective to ensure no failure or involuntary dislocation.

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: Not specified in terms of clinical cases or patient data, as this is bench testing. For bench testing, "sample size" would refer to the number of device components tested, which is not detailed in this summary.
• Data Provenance: Non-clinical bench testing. The country of origin of testing is not specified, but the device is manufactured by a US-based company (Consensus Orthopedics, Inc., El Dorado Hills, California).
• Retrospective/Prospective: Not applicable. This is non-clinical bench testing.

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 this context refers to the physical properties and performance of the device component itself, evaluated through engineering tests, not interpretation by medical experts.

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

Not applicable. This refers to the adjudication of clinical outcomes or diagnostic interpretations, not bench testing results.

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 a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

The "ground truth" for this device's evaluation is derived from engineering specifications and the established performance standards of ASTM F1800-12 for fatigue testing, as well as functional testing for the distal plug's retention and operability.

8. The sample size for the training set:

Not applicable. This is a conventional medical device, not an AI/CAD system.

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

Not applicable. This is a conventional medical device, not an AI/CAD system.

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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.

This device is intended to be used with cemented knee constructs.

The Persona 14 x+30mm Tapered Stem Extension is intended for implantation for total knee arthroplasty (TKA) when supplemental tibial baseplate support is needed. Extending into the intramedullary canal from the base of the Persona Cemented Stemmed Tibia Baseplate, the Persona 14 x+30mm Stem Extension provides supplemental support and shields the fixation interfaces from excessive stress by resisting bending and torsional moments. The subject device is intended to be used with cement knee constructs.

Here's an analysis of the provided text regarding the Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension, focusing on acceptance criteria and the supporting study:

The provided document (K133737) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It's important to note that this device is a physical implant (a knee system component), not an AI/software device. Therefore, many of the requested fields related to AI study design (like MRMC, human readers, ground truth for training data, etc.) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes "performance characteristics" and the "Test Results" demonstrating that the device meets these characteristics. The context implies that the acceptable outcome is for the device to demonstrate sufficient strength or to be assessed for risk in comparison to existing devices, aligning with established FDA guidance for orthopedic implants.

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

• Sample Size: The document does not specify the exact sample size (e.g., number of test specimens) for each bench test. For mechanical tests like fatigue and strength, multiple samples are typically tested, but no numbers are provided here.
• Data Provenance: The data is non-clinical bench testing, meaning it was generated in a laboratory setting, not from human or animal subjects. The location of the testing is not explicitly stated but would typically be in the sponsor's (Zimmer, Inc.) labs or a qualified contract testing facility. This is retrospective in the sense that the testing was performed and then reported, but it is not clinical data.

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

This question is not applicable as the study involves mechanical bench testing of an orthopedic implant component, not an AI or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is defined by engineering principles and measurement of physical properties.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical tests rely on objective measurements from standardized equipment rather than subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. This is a submission for a physical orthopedic implant component, not a diagnostic device or AI system that would involve human readers. Clinical data and conclusions "were not needed for this device."

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

This question is not applicable as the device is a physical knee implant component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is defined by:

• Mechanical Properties: Measured physical characteristics such as fatigue life, axial strength, torsional strength.
• Engineering Standards and FDA Guidance: Compliance with relevant ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards (implied by the FDA guidance documents cited) that define appropriate testing methodologies and performance expectations for such devices.
• Comparison to Predicate Devices: Performance relative to legally marketed predicate devices, demonstrating similarity in performance characteristics.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a physical medical device and not an AI or machine learning model.

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

This question is not applicable for the same reasons as #8.

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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.
  This device is intended for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This document describes the non-clinical performance testing for the Zimmer® Persona™ Personalized Knee System, a semi-constrained modular knee prosthesis. Since this is a medical device (knee implant) rather than an AI/software device, many of the requested fields (multi-reader multi-case study, ground truth establishment, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly demonstrating "sufficient" or "adequate" strength/wear/constraint, or being "comparable" to predicate devices. The "Test Results" column describes how the device performance met these implicit criteria.

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

The document does not explicitly state the sample sizes for each mechanical test. These "tests" are non-clinical (laboratory-based mechanical and wear simulations) rather than using patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as these are not studies involving human subjects or patient data.

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

Not applicable. This is a medical device, not an AI/software device that requires expert ground truth for its performance evaluation. The "ground truth" for these tests is based on established engineering principles, industry standards (e.g., ISO 14243), and comparison to predicate devices, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical mechanical testing, not a clinical study requiring human adjudication.

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 a physical medical device (knee implant), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant.

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

Not applicable. As this is not an AI/software device, the concept of a "standalone algorithm" is not relevant. The device itself (the knee implant) is the "standalone" item being tested in these non-clinical performance studies.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests is based on:

• Industry Standards: For instance, wear testing was conducted "Under Load and Motion Curves From the ISO 14243 Standard."
• Established Engineering Principles: Tests like fatigue, static shear strength, and contact mechanics rely on well-known engineering material and biomechanical principles.
• Predicate Device Performance: Many tests established comparability to existing, legally marketed predicate devices (e.g., NexGen articular surfaces, NexGen predicate devices). The performance of these predicate devices, which have a history of safe and effective use, serves as a benchmark or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device (knee implant), not a machine learning or AI algorithm. There is no concept of a "training set" for the device itself.

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

Not applicable, as there is no training set for this type of 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 ratellofemoral 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.
  This device is intended for cemented use only.

The NexGen MIS Modular Tibial Plates and Keels are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.

The provided text is a 510(k) summary for the Zimmer NexGen MIS Modular Tibial Plates and Keels. It is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.

Therefore, the document does not contain the information required to populate the requested table about acceptance criteria, device performance, or details about a study proving the device meets those criteria.

Specifically, the document states:

• Performance Data (Nonclinical and/or Clinical): "Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This indicates that the Zimmer NexGen MIS Modular Tibial Plates and Keels were cleared based on design assurance performance testing and substantial equivalence to a previously cleared predicate device (NexGen Complete Knee Solution, K933785, cleared January 30, 1995), not on clinical studies with specific acceptance criteria as you've requested. The modifications from the predicate device were considered minor and not to change the intended use or fundamental scientific technology.

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