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The Freedom® Medial Congruent Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following:

• · Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
• · Correction of functional deformities.
• · Post-traumatic loss of knee ioin contour, particularly when there is patellofemoral erosion.
• dysfunction, and/or prior patellectomy.
• · Moderate valqus, varus, or flexion trauma.
• · Knee fractures untreatable by other methods.

The Freedom® Medial Congruent Tibial Liner is intended for cemented use only. This device is for single use only.

Freedom® Medial Congruent Liners have been developed with the desire to achieve a higher level of constraint than typically achieved in a traditional CR knee design while also providing the femoral component with a medial-pivoting motion throughout a range of motion. They possess an anterior and buildup and a higher sagittal conformity of the medial compartment that interact with the femoral component, to provide additional constraint.

Designed to be used with the Freedom CR Femoral Component.

Eliminates the need to remove bone for a PS box.

Designed to allow high flexion.

Includes a deep anterior patellar cut-out to allow for tendon clearance.

Facilitates intraoperative flexibility, given compatibility with existing femoral and tibial baseplate options

The provided text is a 510(k) summary for a medical device called the "Freedom® Medial Congruent Liner." This document describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (Freedom Ultracongruent CR Tibial Liner, K182574) through non-clinical testing. Instead of specific numerical thresholds for performance, the acceptance is based on demonstrating equivalency or satisfactory performance relative to the predicate.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document indicates that the tests were performed on "the Subject Device." It does not specify a numerical sample size for the devices tested. Given that these are non-clinical (mechanical/simulation) tests, the "sample size" might refer to the number of simulations or physical prototypes tested, which is not stated.
• Data Provenance: The tests are non-clinical studies (simulations and characterization tests) rather than human subject data. Therefore, concepts like "country of origin" or "retrospective/prospective" do not apply. The data is generated from laboratory testing and computational modeling.

3. Number of Experts and Qualifications for Ground Truth

• This device's substantial equivalence is demonstrated through non-clinical engineering testing and simulation, not clinical data requiring expert review for "ground truth." Therefore, the concept of "experts" establishing ground truth in the radiological sense is not applicable here. The "experts" involved would be the engineers and scientists conducting and reviewing the test methods and results.

4. Adjudication Method for Test Set

• As this is non-clinical testing, there is no "adjudication method" in the sense of clinician review or consensus. The results are based on objective measurements and computational outcomes compared against predefined standards (ASTM standards) and the predicate device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted or reported. This filing is for a medical implant (knee liner), not a software or AI product that assists human readers in diagnosis. The evaluation focuses on the mechanical and design properties of the implant itself.

6. Standalone (Algorithm Only) Performance

• No, this concept is not applicable. The device is a physical knee implant component, not a software algorithm.

7. Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is derived from:
  • Engineering Principles and Benchmarks: Adherence to established ASTM (American Society for Testing and Materials) standards (F2083, F1223).
  • Computational Simulations: Computer-AAided-Design (CAD) software for range of motion.
  • Direct Mechanical Comparison to Predicate Device: Physical and performance characteristics of the subject device are directly compared to those of the legally marketed predicate device.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design and testing are based on engineering principles and comparison to a predicate, not data-driven model training.

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

• Not applicable, as there is no training set.

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The Opulent TiNbN Coated Knee is indicated for the following:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.

· Correction of functional deformities.

• · Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• · Knee fractures untreatable by other methods.
• · Revision surgery where sufficient bone and soft tissue integrity are present.

The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of a Femoral Component and Tibial Component as described below,

• Femoral Knee Component CR and PS (Left and Right) ●
• Tibial Component (Tibial Base Plate) ●

Each of these components is described below. These components are compatible with previously cleared components of the Destiknee Total Knee System (e.g., patellae, tibial inserts).

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a knee prosthesis called "Opulent TiNbN Coated Knee."

This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a detailed clinical study demonstrating meeting specific performance acceptance criteria for a novel device. While it mentions non-clinical performance data and mechanical tests, it doesn't provide specific acceptance criteria values or the detailed results of a study designed to prove the device meets those criteria in the context of the questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, effect sizes, standalone performance).

The information provided includes:

• Device Name: Opulent TiNbN Coated Knee
• Regulation Number: 21 CFR 888.3560 (Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: JWH
• Predicate Device: Freedom® - TiNbN Coated Knee (K200912) from Maxx Orthopedics Inc., USA, and Destiknee Total Knee System (K160771 and K172936) from Meril Healthcare Pvt. Ltd.
• Device Description: Comprises Femoral and Tibial Components, made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) coated with Titanium Niobium Nitride (TiNbN).
• Indications for Use: Severe knee joint pain, loss of mobility, disability due to various arthritis types, correction of functional deformities, post-traumatic loss of knee joint contour, moderate valgus/varus/flexion trauma, knee fractures untreatable by other methods, and revision surgery. Intended for cemented use only, single use.
• Comparison of Technological Characteristics: Stated to be substantially equivalent to the predicate device with same indications, design, materials, packaging, surgical implantation technique, intended use, TiNbN coating, and sterilization method.
• Non-clinical Performance Data: Mentions mechanical tests performed on TiNbN coating (Wear Resistance, Coating Chemical Composition, Coating Thickness, Coating Hardness, Coating Adhesion Strength, Roughness, Metal Ion Analysis) and leveraged mechanical tests from predicate devices (Tibial-Femoral Contact Area Stress and Surface Stress Testing, Tibial-Femoral Constraint Testing, Range of motion analysis, Patello-Femoral Lateral Subluxation, Patello-Femoral Contact Area Stress and Surface Stress Testing, Tibial Tray Locking Mechanisms Testing, Finite Element Analysis of Tibial Tray, Tibial base plate component fatigue testing, Tibial Post Fatigue Strength).

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert review, MRMC studies, or training data for a typical AI/software device evaluation, as this document pertains to a mechanical knee implant and a substantial equivalence review for a 510(k) clearance.

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The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities,
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods
  The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is intended for cemented use only. This device is for single use only.

The Maxx Orthopedics' Freedom® CR Femoral Component is compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019 and the Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The proposed Freedom® CR Femoral Component consist of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom® Total Knee System described in K082019 and the Freedom Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component (posterior stabilizing), an all-poly tibial component, and a patellar component. The Freedom Metal Backed Tibial Component subject of K090411 consists of a metal backed tibial component and polyethylene insert. The proposed CR Femoral Component will provide the surgeon with an alternative femoral component in the event that the surgeon prefers to use a CR component rather than the PS component with the Freedom® Total Knee System. In addition, a second metal backed tibial component was cleared for use with the Freedom Total Knee System under K090411. The proposed CR Femoral Component and a (UHMWPE) insert will be used in place of the PS Femoral component with the Freedom® Total Knee System.
The CR Femoral Component of the Freedom® Total Knee System CR is designed to replace the articulating surface of the distal femur. The cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Freedom® Total Knee Cruciate Retaining (CR) Femoral Component) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, along with some general information about performance testing.

Specifically, the document states:

• "Mechanical and functional testing described in K082019, K090411 and in Section 8 demonstrates that the Freedom® CR Femoral Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems."
• "Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® CR Femoral Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Fernorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
• "The verification and validation testing have been performed which demonstrate that the CR Femoral Component functions as intended and is safe and effective for its intended use."

However, it does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance against those criteria.
3. Details about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for software/AI components. This is likely because the device is a physical knee implant, not a software or AI-driven diagnostic/treatment tool.

Therefore, I cannot provide the requested table and information.

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The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are designed to be used with the Freedom® Total Knee System. The Maxx Orthopedics' Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.

The Maxx Orthopedics' Freedom Total Knee System is intended for cemented use only. This device is for single use only.

The Maxx Orthopedics' Freedom® Metal Backed Tibial Component and Ultra High Molecular Weight Polyethylene (UHMWPE) insert are compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.

The Freedom® Metal Backed Tibial Component and UHMWPE insert are intended to be used with the Freedom® Total Knee System. The proposed metal backed Tibial Component and UHMWPE insert will be used in place of the all-poly tibial component with the Freedom® Total Knee System.

The proposed metal backed tibial component consists of a cobalt-chromiummolybdenum tray, and the insert is made from UHMWPE. These components are intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection.

The tibia base components are designed with a keel portion which extends into the proximal tibial medullary canal. The more distal portion of the tibial base has a flat plate that rests on the patient's tibial plateau region. On the underside of this plate are cement recesses allowing allow for cement interdigitation which helps to provide rotational stability. The Freedom® Knee tibial inserts have an interlocking relation to the tibial base. The Freedom® Knee femoral components articulate with the bearing base (proximal) surface of the tibial inserts. The articulating surface of these inserts is identical to the articulating surface of the all-poly liner components mentioned in the already cleared Freedom® Total Knee System (K082019).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., minimum fatigue life, maximum wear rate). Instead, the acceptance is based on demonstrating mechanical and functional similarity to predicate devices and adherence to relevant guidance documents.

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

The document does not specify a "test set" in the context of clinical data or human-interpreted data. The performance testing describes mechanical and functional testing, not a clinical study on patients. Therefore, information regarding sample size and data provenance (country of origin, retrospective/prospective) for a test set is not applicable or provided.

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

This information is not applicable as the document describes mechanical and functional testing of a medical device, not a study requiring expert interpretation of diagnostic data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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 information is not applicable. The document describes the mechanical testing and substantial equivalence of a knee implant, not an AI or imaging diagnostic device. Therefore, MRMC studies are not relevant.

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

This information is not applicable. The device is a physical knee implant, not an algorithm.

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

For the mechanical and functional testing, the "ground truth" would be established by engineering standards, material specifications, and biomechanical performance requirements derived from the Class II Special Controls Guidance Document and comparisons to predicate devices. This is not the same as a clinical "ground truth" established by pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical knee implant, not a machine learning model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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