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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 Freedom® Total Knee System is indicated for patients with severe knee pain and the 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, 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® Total Knee System – Titan PCK Components are intended for cemented and single use only.

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 K091280, K192148, K090411, K182574, K131481, K111785, K200912, and K240863 respectively.

This submission seeks the clearance of Titanium Niobium Nitride (TiNbN) coated version of previously cleared Femoral Augment (non-coated version cleared in K131481), Tibial Augments, Stem Extension & Offset Junction (non-coated versions cleared in K111785). The coated versions are now branded as Freedom® Total Knee System – Titan PCK Components.

Below is the description of the coated components.

Freedom® Titan Femoral Augments

The Freedom® Titan Femoral Augments are fabricated from Titanium-6Aluminum-4Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the internal distal and posterior surfaces of the previously cleared PCK Stemmed Femoral Component (K131481) and Titan PCK Stemmed Femoral Component (K240863) 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, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Femoral Component and other augments.

The Freedom® Titan Femoral Augments is available in distal and posterior design configuration. Each configuration is further available in 6 different sizes.

Freedom® Titan Tibial Augments

The Freedom® Titan Tibial Augments are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). These augments are intended to be screwed to the distal surface of the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) 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, and are coated with Titanium Niobium Nitride (TiNbN), are available as an accessory to the system to fix the augments to the Stemmed Tibial Base Plate and other augments.

Freedom® Titan Offset Junction

The Freedom® Titan Offset Junctions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). Offset Junctions are intended to be used with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863) to provide an additional 4mm or 6mm offset between the tibial keel and stem. 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® Titan Stem Extension

The Freedom® Titan Stem Extensions are fabricated from Titanium-Aluminum-Vanadium (Ti-6A1-4V), complaint with ASTM F136, and are coated with Titanium Niobium Nitride (TiNbN). The Titan Stem Extensions are intended for use with the previously cleared Stemmed Tibial Base Plate (K111785) & Titan Stemmed Tibial Base Plate (K240863). The 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.

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This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

Note: In the US, this device is for cemented use only.

"UNITED" U2 Total Knee System – Posterior Stabilized Augmentable (PSA) type is a patellofemorotibial polymer/ metal/ polymer, semiconstrained, cemented knee prosthesis, which has a metallic femoral component and a tibial component composed of a polyethylene insert and a metallic tibial baseplate. Tibial inserts are available in two design configurations: for the PSA type insert, it is intended for use in patients who require constrained stabilization of the tibiofemoral joint due to soft tissue imbalance. While the PSA low constrained type (PSA, LC) insert provides less constrained stabilization than the PSA type insert.

This system is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. There are a variety of components including femoral augment set, tibial augment, stem extension and offset stem adapter that provide more choices for surgeon to treat their patients. In addition, this system provides more stability for patients with inadequate medial-lateral, anterior-posterior or varus-valgus soft tissue imbalance. For total knee replacement, "UNITED" patella components are intended to be used with the U2 Total Knee System—PSA Type.

For the subject device, it's a line extension of the 510(K) cleared device U2 Total Knee System—PSA Type (K082424), which introduces the variation, Straight Stem, Cross Slot, PSA, with stem lengths from 75mm to 200mm, diameters from Ø10 to Ø24mm.

The compatibility of the Straight Stem, Cross Slot, PSA is the same as that of the 510(k) cleared U2 Total Knee System—PSA Type (K082424).

The Straight Stem, Cross Slot, PSA is an extension of the geometric characteristics of the 510(k) cleared device, U2 Total Knee System—PSAType (K082424). Its materials, size, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Straight Stem, PSA.

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Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

• Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.

The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.

The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System and AGC® Complete Knee system prostheses families only

The Materialise TKA Guides are intended for single use only.

• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty® Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

The subject device is a system that consists of the following two functional components:

• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.

• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

The provided FDA 510(k) clearance letter and summary for the Materialise TKA Guide System describes the device and its indications for use, but it does not contain the specific acceptance criteria or the details of a study (like a clinical study or specific performance data) that proves the device meets those criteria.

Instead, the document primarily focuses on establishing "substantial equivalence" to a predicate device (Materialise TKA Guide System K221337) and a reference device (Materialise PKA Guide System K202207). It states that "The non-clinical performance testing indicates that the subject device is as safe and effective as the predicate device." However, it does not provide the actual results of this non-clinical performance testing in terms of specific acceptance criteria and detailed study outcomes.

The information given is typical for a 510(k) summary, which generally affirms that V&V (Verification and Validation) was done and that the device performs as intended, but it doesn't usually include the granular details of the V&V studies themselves, especially not in a public-facing clearance letter. These details would be contained within the full 510(k) submission, which is not publicly accessible in its entirety.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide answers to most of your specific questions (sample size, data provenance, expert details, adjudication, MRMC study, ground truth type, training set details) because this information is not present in the provided text.

The document mentions:

• Software verification and validation: "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs." This implies acceptance criteria were defined (as "defined requirements" and "user needs") and met, but the specific metrics and results are not listed.
• Hardware testing: "Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device (no changes have been applied to the Hardware)." Again, this confirms testing occurred and was successful, but the specific criteria and outcomes are omitted.

In summary, none of the specific data you requested (acceptance criteria, study details, sample sizes, expert qualifications, etc.) are available in the provided FDA 510(k) clearance letter.

To provide the information you're looking for, one would typically need access to the full 510(k) submission, specifically the V&V reports, which are proprietary and not released with the public clearance letter.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• 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;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Revision VVC+, e+™ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications:

• 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 EMPOWR Revision Knee™ system is intended for use in total knee arthroplasty. The system includes femoral components, tibial components, tibial inserts, cones, stems, stem extenders, and augments. Components are available in various sizes and configurations to accommodate a range of patient anatomies and surgeon preferences.

The purpose of this submission is to obtain clearance for using vaporized hydrogen peroxide (VHP) as a sterilization method for the EMPOWR VVC+, e+ Tibial Insert component. The subject device is identical in design, materials, and intended use to the predicate.

This FDA 510(k) clearance letter pertains to a medical device, the EMPOWR Revision Knee™ system, specifically focusing on the clearance for a new sterilization method (Vaporized Hydrogen Peroxide - VHP) for the EMPOWR Revision VVC+, e+ Tibial Insert component. The document explicitly states that no clinical data or animal studies were submitted for this clearance. Instead, the substantial equivalence to the predicate device is based on non-clinical performance data (verification and validation activities).

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical or AI-based study cannot be extracted from this document, as it is not relevant to the type of submission described.

The document discusses the following non-clinical performance data:

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

   • This information is not explicitly presented in a table format within the provided document. However, the document states that "Verification and validation activities demonstrate substantial equivalence between the subject and predicate devices." and lists the types of tests conducted. To fully answer this, one would typically need access to the actual verification and validation reports.

   Acceptance Criteria (Implied)	Reported Device Performance (Implied)
   Sterilization Efficacy	Validated for VHP
   Shelf-Life Stability	Demonstrated stability
   Packaging Integrity	Demonstrated integrity
   Biocompatibility (Cytotoxicity)	Met biocompatibility requirements
   Material Properties	Maintained material characteristics
   Wear Resistance	Comparable to predicate (Pin-on-disk)
   Fatigue Strength (Lock Detail)	Met strength requirements
   Fatigue Strength (Tibial Post)	Met strength requirements

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

   • Sample sizes: Not specified in the provided text. These would be detailed in the individual test reports for each verification and validation activity.
   • Data provenance: Not specified. This would typically come from internal laboratory testing or contract research organizations. The document indicates these are "Verification and validation activities," implying laboratory-based testing.

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

   • Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in the traditional sense. The "ground truth" for non-clinical testing refers to established engineering or biological standards.

4. Adjudication method for the test set:

   • Not applicable. Adjudication is typically for clinical or interpretation-based studies. Non-clinical tests follow predefined protocols and acceptance limits.

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. The document explicitly states: "No clinical data submitted." This is not a study involving human readers or AI.

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

   • No. This is not an algorithm-based device.

7. The type of ground truth used:

   • For the non-clinical tests listed (Sterilization Validation, Shelf-Life Study, Packaging Testing, Cytotoxicity, Material Characterization, Pin-on-disk Wear, Lock Detail Fatigue, Tibial Post Fatigue), the "ground truth" would be established engineering standards, regulatory requirements, and validated testing methodologies.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable. This is not an AI/machine learning device requiring a training set.

In summary, the provided document is a 510(k) clearance letter for a medical device that highlights a change in sterilization method. The substantial equivalence argument is based entirely on non-clinical performance testing, not clinical trials or AI performance evaluations. Therefore, most of the requested information related to clinical studies, AI performance, expert ground truth, and sample sizes for such studies is not applicable to this specific submission.

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Intended Use:

The EMPOWR Revision Knee™ Symmetric TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon. The EMPOWR Revision Knee™ Symmetric TT Cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Indications for Use:

The EMPOWR Revision Knee™:

Total joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• 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;
• treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions.

The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions:

• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon.
• EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

The EMPOWR Revision Knee™ Symmetric TT (Trabecular Titanium) Cones are an optional accessory in primary or revision Total Knee Arthroplasty. The EMPOWR Symmetric TT Cones are sterile, single-use devices that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR Symmetric TT Cones are composed of Ti6Al4V alloy (per ASTM F1472 and ISO 5832-3) and feature a porous Trabecular Titanium (TT) structure on the external surface of the implant. The EMPOWR Symmetric TT Cones are additively manufactured via Electron Beam Melting in the same manner as the reference AMF TT Cones device.

This document is an FDA 510(k) clearance letter for a medical device: the EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones).

It is crucial to understand that this document DOES NOT contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) clearance process for this orthopedic implant relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through bench testing (mechanical performance) and, in some cases, clinical data if significant differences exist. This is a very different type of clearance than for AI/ML devices, which require performance data related to algorithmic accuracy or clinical utility.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training sets, experts, adjudication, MRMC, standalone performance, ground truth establishment) because it is not present in this document.

The document states:

• "No animal data submitted."
• "No clinical data submitted."
• "All testing and evaluations demonstrate that the subject device is substantially equivalent to the primary predicate."

The performance testing listed focuses on mechanical properties (Dynamic Fatigue Testing, MR Conditional Labeling), which are relevant for an orthopedic implant but entirely different from the performance metrics and study designs expected for an AI/ML diagnostic or assistive device.

In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance data for an AI/ML device.

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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, 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® Total Knee System – Titanium Tibial Base Plate is intended for cemented and single use only.

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 K091280, K192148, K090411, K182574, K131481, K111785 and K200912 respectively.

The primary purpose of this special 510(k) Device Modification to the Freedom® Metal Backed Tibial Component (K090411) is to notify the FDA of the change in materials used to manufacture the tibial base plate from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) as an alternative material option for the tibial base plate.

The Titanium Tibial Base Plate is fabricated from Titanium alloy Ti-6Al-4V ELI, compliant with ASTM F136 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.

This 510(k) clearance letter pertains to a Class II medical device, specifically the Freedom® Total Knee System - Titanium Tibial Base Plate (K251717). The submission is a special 510(k) Device Modification, indicating that the changes made to the device are well-defined and do not significantly alter the indications for use or raise new questions of safety and effectiveness.

The core change is the material of construction for the tibial base plate, shifting from CoCrMo to Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti-6Al-4V ELI). The design, geometry, surfaces, and locking features remain identical to the previously cleared predicate device (K090411).

Therefore, the acceptance criteria and the study proving the device meets these criteria primarily focus on mechanical performance and biocompatibility related to this material change, rather than extensive clinical efficacy studies or comparative effectiveness studies involving human readers, as would be typical for AI/software devices.

Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a material change for an orthopedic implant with identical design), the acceptance criteria are not explicitly numerical thresholds like sensitivity/specificity, but rather involve demonstrating mechanical equivalence to the predicate device and biocompatibility of the new material.

Here's a table summarizing the implicit acceptance criteria based on standard regulatory requirements for such a device modification, and how the document indicates they were met:

Study Details (Relevant to Orthopedic Implants, Not AI)

The provided text describes a submission for an orthopedic implant and does not involve an AI/software component, nor does it detail a clinical study with human patients for AI performance evaluation. Therefore, many of the requested points regarding sample sizes for test/training sets, expert readers, ground truth for AI, MRMC studies, etc., are not applicable to this type of device clearance and are consequently not found in the document.

However, based on the information provided, here's what can be inferred/stated:

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

   • Test Set: Not applicable in the context of clinical AI performance data. For mechanical testing (ASTM F1800), standard test methods specify the number of samples required (e.g., minimum of 6 samples for fatigue per ASTM F1800-97), but the exact number used in this specific submission is not reported in the summary.
   • Data Provenance: Not applicable for AI performance data. For material and design, the device is manufactured by Maxx Orthopedics Inc. (Norristown, PA, USA) and Meril Healthcare Pvt. Ltd. (Vapi, Gujarat, India).

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

   • Not applicable as this is a mechanical and material modification, not an AI diagnostic device requiring expert interpretation of images for ground truth.

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

   • Not applicable for the type of device/study described.

4. 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 type of study (MRMC, AI assistance) is not relevant or performed for this device. The submission is for a physical orthopedic implant with a material change.

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

   • Not applicable, as there is no algorithm or AI component in this device.

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

   • For the mechanical testing, the "ground truth" would be the engineering specifications and performance of the predicate device, alongside adherence to international standards (e.g., ASTM F1800).
   • For biocompatibility, the "ground truth" is established long-term clinical use data, compliance with ASTM F136 (Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications), and prior FDA clearances of devices using this material.

7. The sample size for the training set:

   • Not applicable (no AI training set).

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

   • Not applicable (no AI training set).

In summary, the FDA clearance for K251717 as a special 510(k) is based on demonstrating that the new Titanium Tibial Base Plate is mechanically equivalent to its predicate and that the new material is biocompatible and has a well-established history of safe use in similar orthopedic applications. The regulatory review focuses on engineering performance criteria and material biocompatibility rather than clinical performance data from patient studies or AI algorithm validation.

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The NextStep Arthropedix Total 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 arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, 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 NextStep Arthropedix Total 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 NextStep Arthropedix Total Knee System is designed for cemented use only.

The subject device submission includes a combination of devices based on previously cleared devices (K142649 and K150783) and devices with new designs. This submission will include several identical devices reviewed in K142649 and K150783, new devices not yet reviewed by FDA, and new cleaning, packaging, and sterilization validations for all implants. The subject device submission includes 2 system options for total knee replacement:

• Option 1 – Posterior Stabilized (PS), Cruciate Retaining (CR), and Ultra Congruent Cruciate Retaining (UC-CR) patellofemorotibial total knee replacement system that is based on the Progressive Orthopedic Total Knee System cleared in K142694 and K150783

  • Includes additional femoral component sizes, additional vitamin E UHMWPE material option for the symmetrical tibial inserts, and manufacturing patellar components from vitamin E UHMWPE only.

• Option 2 – Medial Pivot Total Knee System, including cruciate retaining (MP-CR) and cruciate substituting (MP-CS) tibiofemoral articulation

The provided FDA 510(k) clearance letter describes a medical device, the NextStep Arthropedix Total Knee System, but it is not a software device or an AI/ML device.

The document primarily focuses on the mechanical and material properties of a knee implant system, comparing it to predicate devices. There is no mention of "acceptance criteria" related to an algorithm's performance, nor is there a "study" involving data sets, expert ground truth, or statistical measures like sensitivity, specificity, or AUC, which are typical for AI/ML device evaluations.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The concepts of "test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," and "training set" are not applicable to the information provided in this 510(k) summary for a physical knee implant.

The "Non-Clinical and/or Clinical Tests Summary" section lists mechanical tests performed for the physical device, such as fatigue performance, interlock mechanism strength, and wear testing. These are physical tests, not evaluations of an AI algorithm's computational performance.

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EXULT Knee Replacement System is indicated for the treatment of diseases as follows:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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;
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

The EXULT Knee Replacement System is intended for cemented use only.

The purpose of this submission is to introduce EXULT Tibial Insert UCR (Ultra Congruent & Cruciate Retaining) which is a line extension to the EXULT Knee Replacement System.

The EXULT Tibial Insert UCR is a modification to the PCL (Posterior Cruciate Ligament) notch of the EXULT Tibial Insert UC (K242046). This change allows the EXULT Tibial Insert UC to be used by surgeons who do not resect the PCL when implanting an EXULT Tibial Insert UC. Tibial Insert is used at both right and left knee. It is only used in combination with the same Femoral component and Tibial baseplate of the predicate device.

The provided FDA 510(k) clearance letter for the EXULT Knee Replacement System (K250889) does not contain any information about an AI/ML-driven medical device, nor does it include details about a study that assesses AI/ML performance against acceptance criteria.

This document pertains to a medical device (a knee replacement system) that is a physical implant made of materials like UHMWPE. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biomechanical tests to ensure the mechanical integrity, wear characteristics, range of motion, and other physical properties of the knee implant.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI/ML device based on this input. The provided text does not contain any of the required information regarding AI/ML performance, sample sizes for AI/ML test sets, expert ground truth adjudication, MRMC studies, standalone AI performance, or training set details.

The "Non-Clinical Testing" section on Page 7 lists the following mechanical/physical tests:

• Contact area/pressure per ASTM F2083
• Interlocking test per ASTM F1814
• Wear of articular surface per ISO 14243-2/3
• Range of Motion analysis per ISO 21536
• Constraint analysis per ASTM F1223
• Endurance and deformation under high flexion per ASTM F2777

These are standard tests for orthopedic implants and are not related to AI/ML performance. The "Clinical Testing" section explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject device." This further confirms that no clinical study involving human readers or AI assistance was conducted for this device.

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• Rheumatoid arthritis;
• Post-traumatic arthritis, osteoarthritis, or degenerative arthritis;
• Posterior stabilized and constrained knee systems are also indicated for the treatment of unicompartmental replacement or total knee replacement;
• Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
• Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.

The subject insert is a line addition to the LEGION Inserts with JOURNEY Lock (K200407) and has undergone design modifications to provide a new articulating surface that incorporates a flatter lateral plateau and extended medial geometry to match the asymmetry of the tibial baseplate, while maintaining the JOURNEY locking mechanism. The subject LEGION Medial Stabilized Inserts with JOURNEY Lock have a size range of 1-2, 3-4, 5-6, and 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18mm, and come in both left (LT) and right (RT) configurations. The LEGION Medial Stabilized XLPE Inserts with JOURNEY Lock are provided sterile via Ethylene Oxide sterilization and are intended for single use only. The subject inserts are intended to be used with compatible knee systems for total knee arthroplasty in skeletally mature patients with or without bone cement.

I am sorry, but based on the provided FDA 510(k) clearance letter for the LEGION Total Knee System, the document does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/human-in-the-loop performance study.

Here's why the requested information cannot be found in the provided text:

• Device Type: The cleared device, the "LEGION Total Knee System," is a physical medical device (a knee joint prosthesis), not an AI/software device. The 510(k) is for a hardware modification (a new articulating surface for an insert).
• Study Type: The document states, "No clinical testing was performed to support safety and effectiveness of the subject device." The testing mentioned is "bench testing" (Tibiofemoral Constraint Testing and Tibiofemoral Contact Area Testing) which applies to the physical properties of the knee implant.
• AI/Human-in-the-loop: There is no mention of AI, human readers, ground truth establishment by experts, or MRMC studies, as the device is not an AI diagnostic or assistance tool.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes for AI test sets, expert numbers, adjudication methods, MRMC studies, standalone AI performance, or training set details, as these concepts are not applicable to the cleared device as described.

The document focuses on demonstrating substantial equivalence of a new knee implant component to existing, legally marketed predicate devices through material and mechanical performance testing.

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