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The Freedom Infinia™ 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, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present. (For PCK Components and Primary PCK Components only)

The Freedom Infinia™ Total Knee System components are intended for cemented and single use only. The Freedom Infinia™ Cementless Femoral (CR and PS) Components and Porous Tibial Base Plates are additionally indicated for cementless biological fixation application.

The Freedom® Total Knee System is comprised of a femoral component, all-poly tibial component, patellar component, tibial base plate and tibial articular surface. The Freedom® Total Knee System's Femoral Component is offered as different versions such as stemmed PCK design, primary PCK, cruciate retaining, posterior stabilizing. The Freedom® Total Knee System's Tibial Base Plate is offered with stemmed design and without stemmed design. The Freedom® Total Knee System was originally cleared under the 510(k) number K082019. Later on, several modifications were made and were cleared under 510(k)s K090411, K091280, K111785, K131481, K150680, K182574, K192148, K241597, K243277, K251717 respectively.

This submission seeks the clearance of an additional brand, Freedom Infinia™ Total Knee System.

Below is the description of the Freedom Infinia™ Total Knee System's components.

Freedom Infinia™ Femoral Component

The Freedom Infinia™ Total Knee System's Femoral Component is offered in both cruciate retaining and posterior stabilizing designs. The Femoral components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom Infinia™ Total Knee System's Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection.

Freedom Infinia™ Cementless Femoral Component

The Freedom Infinia™ Total Knee System's Cementless Femoral Component is offered in both cruciate retaining and posterior stabilizing designs. The Cementless Femoral Components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom Infinia™ Total Knee System's Cementless Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and porous coated CoCr beads and is intended for cementless biological fixation application to replace the articulating surface of the distal femur in a measured resection.

Freedom Infinia™ Stemmed Femoral Component

The Freedom Infinia™ Total Knee System's Stemmed Femoral Component with progressive constraint (PCK) is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75, intended for cemented application to replace the articulating surface of the distal femur in a measured resection technique. It is available in left and right configurations. Each configuration is further available in 8 different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus total of 16 models are available for the Stemmed Femoral Component.

Freedom Infinia™ Femoral Augments

The Freedom Infinia™ Total Knee System's Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136. These augments are intended to be screwed to the internal distal and posterior surfaces of Freedom Infinia™ PCK Stemmed Femoral Component when required in cases of significant bone loss. The augments are designed to be stackable and for use on either the medial or lateral side.
Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, are available as an accessory to the system to fix the augments to the Freedom Infinia™ Stemmed Femoral Component and other augments.
The Freedom Infinia™ Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.

Freedom Infinia™ Primary PCK Femoral Component

Freedom Infinia™ Total Knee System's Primary PCK Femoral Component is designed to be used with the Freedom Infinia™ Stemmed Tibial Components. It is fabricated from Cobalt- Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application.

Freedom Infinia™ Tibial Base Plate

The Freedom Infinia™ Total Knee System's Tibial Base Plate is fabricated from Cobalt- Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

Freedom Infinia™ Titanium Tibial Base Plate

The Freedom Infinia™ Total Knee System's Titanium Tibial Base Plate is fabricated from Wrought Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136-13 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Titanium Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

Freedom Infinia™ Porous Tibial Base Plate

The Freedom Infinia™ Total Knee System's Porous Tibial Base Plate is intended for use with existing, compatible Femoral Components and Tibial Liner Components. Freedom Infinia™ Porous Tibial Base Plates are additively manufactured from Ti-6Al-4V ELI Grade 23 and include a porous lattice structure on the distal face. Freedom Infinia™ Porous Tibial Base Plates are available in eight asymmetric design offerings (Sizes 1 – 8, Left / Right configurations), based on anterior / posterior (A/P) and medial / lateral (M/L) dimensions.

Freedom Infinia™ Stemmed Tibial Base Plate

The Freedom Infinia™ Total Knee System's Stemmed Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum (CoCrMo) alloy complying with ASTM F75 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection technique. The Stemmed Tibial Base Plates are available in 8 different sizes (1 to 8) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions and are supplied with UHMWPE plugs to close off augment screw holes and distal taper when not used and with a set screw to provide additional locking to the stem or offset junction during extraction.

Freedom Infinia™ Tibial Augments

The Freedom Infinia™ Total Knee System's Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136. These augments are intended to be screwed to the distal surface Freedom Infinia™ Stemmed Tibial Base Plate when required in cases of significant bone loss. The augments are designed to be stackable, using a system of pins, bosses and screws, and reversible for use on either the medial or lateral side. Augment Screws, fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.

Freedom Infinia™ Stem Extension

The Freedom Infinia™ Total Knee System's Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136. The Freedom Infinia™ Stem Extensions are intended for use with Freedom Infinia™ Stemmed Tibial Base Plate. The Freedom Infinia™ Stem Extensions are available in a range of diameters and lengths and are fluted distally with a distal slot in the larger lengths and diameters.

Freedom Infinia™ Offset Junction

The Freedom Infinia™ Total Knee System's Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, are intended to be used with the Freedom Infinia™ Stemmed Tibial Base Plate to provide an additional 4mm or 6mm offset between the tibial keel and stem. Freedom Infinia™ The Offset Junction is attached to the tibial component and stem through taper junctions. A set-screw is supplied with the Offset Junction to provide additional locking during extraction.

Freedom Infinia™ Tibial Liner

The Freedom Infinia™ Total Knee System's Tibial Liner is available in two designs i.e. posterior stabilizing (PS) and cruciate retaining (CR). Based on the Tibial Liner compatibility with Femoral Component configurations, each PS and CR designs are available various sizes with different anterior/posterior (A/P) and medial/lateral (L/P) dimensions, and each size is further bifurcated as on thickness. Tibial liner is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complying with ASTM F648 and is intended for cemented application along Tibial Base Plate to replace the articulating surface of the proximal tibia in a measured resection. Both the CR and PS Tibial Liners have identical locking mechanisms to mate with the Tibial Base Plate.

Freedom Infinia™ Medial Congruent Liner

The Freedom Infinia™ Total Knee System's 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 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.

Freedom Infinia™ Ultra-Congruent CR Tibial Liner

The Freedom Infinia™ Total Knee System's Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner complies with ASTM F648 that is designed to be used with the Freedom Infinia™ Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom Infinia™ Total Knee System.

Freedom Infinia™ PCK Tibial Liner

The Freedom Infinia™ Total Knee System's PCK Tibial Liner is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complies with ASTM F648. Based on the Tibial liner compatibility with PCK femoral component configurations, each PCK tibial liner design is available different sizes with different anterior/posterior (A/P) and medial/lateral (L/P) dimensions, and each size is further bifurcated on thickness variants.
The PCK Tibial Liners consist of the same articulating surface of existing Tibial liner components and have a same locking mechanism on the peripheral edge of the distal surface to lock into the Tibial / Stemmed Tibial Base Plate. The PCK tibial liner supplied with a liner securing pin manufactured from Ti-6Al-4V ELI to provide additional locking with stemmed tibial base plate.

Freedom Infinia™ All Poly Tibial Component

The Freedom Infinia™ Total Knee System's All Poly Tibial Component is fabricated from ultra high molecular weight polyethylene (UHMWPE) complying with ASTM F648 and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. Both the Total Knee System CR and PS Tibial Inserts have identical locking mechanisms to mate with the Tibial Base Plate.

Freedom Infinia™ All Poly Patella

The Freedom Infinia™ Total Knee System's All Poly Patella is available in symmetrical single radius design. Based on different diameter and thickness different models are available. All Poly Patella is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) complying with ASTM F648.
The symmetric design features a central cement recess, and three pegs on the bone interface surface. The symmetric patellar component is intended for cemented application via an onset resurfacing surgical technique.

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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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