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The Maxx Libertas Bipolar Head is intended for use in combination with a Maxx Libertas Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other devices or treatments for these indications have failed.

The Maxx Libertas Bipolar Head consists of three factory-assembled parts: a cobalt chromium outer shell, a UHMWPE liner, and a UHMWPE retention ring. The outer shell has a highly polished spherical outer surface for articulating with the acetabular joint socket. The liner has an hemispherical inner surface for articulating with the spherical head component of the Libertas femoral stem (28 mm). The retention ring provides a locking function to resist dislocation of the femoral head from the bipolar head.

The provided FDA 510(k) clearance letter and summary for the Maxx Libertas Bipolar Hip Head (K243634) describe the device and its intended use, but it does not contain information regarding statistically significant acceptance criteria derived from a clinical or standalone study comparing the device's performance against specific metrics.

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761) primarily through non-clinical mechanical testing and engineering analysis. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, often by demonstrating similar design, materials, and performance in simulated conditions.

Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, ground truth type) are typically not included in a 510(k) summary that relies solely on bench testing and
engineering analysis for substantial equivalence.

Here's an analysis of the information that is available and what is not based on the provided document:

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

• Range of Motion tests were performed.
• Static push-out tests were performed.
• Static Lever-out tests were performed.
  Engineering Analysis:
• Impingement scenarios analysis was performed.

Overall Conclusion: The device performed "identical to the predicate device," supporting substantial equivalence. |

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

• Sample Size for Test Set: Not applicable/Not provided. The "test set" in this context refers to physical test articles used for mechanical testing, not a patient cohort or imaging dataset. The number of physical samples tested is not specified in the summary.
• Data Provenance: Not applicable/Not provided in the summary. Mechanical testing data does not have country of origin in the same way clinical data would.

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. For mechanical and engineering testing, "ground truth" is established by standard engineering principles, test methods (e.g., ASTM or ISO standards, though not explicitly cited here), and simulation results, not by human experts interpreting clinical data.

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

• Not applicable. This concept applies to human interpretation of clinical data in studies, not to device mechanical testing.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/software devices where human-in-the-loop performance is evaluated. The Maxx Libertas Bipolar Hip Head is a physical orthopedic implant.

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

• No, a standalone performance evaluation in the context of an "algorithm only" or AI device was not done. The "standalone" performance here refers to the mechanical and engineering performance of the physical device.

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

• The "ground truth" for demonstrating substantial equivalence for this device was established based on mechanical test results and engineering analysis comparing the subject device's performance to that of the predicate device under simulated conditions. There is no expert consensus, pathology, or outcomes data mentioned in this submission summary.

8. The sample size for the training set

• Not applicable. This term refers to data used to train AI models. This device is a physical orthopedic implant, not an AI/software device that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Summary of what the study did demonstrate:

The provided document indicates that the Maxx Libertas Bipolar Hip Head gained 510(k) clearance primarily by demonstrating substantial equivalence to a predicate device (BioPro Bipolar Head, K100761). This was achieved through:

• Mechanical Testing: Including Range of Motion, Static push-out, and Static Lever-out tests.
• Engineering Analysis: Specifically for impingement scenarios.
• Technological Comparison: The subject device was deemed "identical to the Predicate Device in design, material, chemical composition, principle of operation."

The conclusion was that the device "performed identical to the predicate device" based on these non-clinical tests, thus supporting its substantial equivalence for the stated Indications for Use.

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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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• 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, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation

The Freedom Total Knee System All-Poly Tibial Plate implants have been developed with the desire to expand upon the already clinically successful Freedom® Total Knee System, melding together the best design features of various sub-systems into one. The implants will retain the key benefits of the All-Poly Tibial implant system while leveraging some of the modular, metal-backed systems (K090411, K182574, K243277). Using the All-Poly design, the articular surface, tibial baseplate, and stem are manufactured from a single component. This eliming from modularity, reduces the overall weight and subsidence risk, adds full radiolucency to the tibial implants, and comes at a reduced cost. Like the original All-Poly Implants, these new versions will be manufactured from GUR 1020 (Type 1) UHMWPE per ASTM F648.

To enhance the existing All-Poly Implant designs, the stem of these implants is being upgraded to the larger, finned stem/keel design from the modular Freedom® Total Knee System (K090411). This will provide the new All-Poly Tibial implanted stability post-operatively and allow surgeons to use the same instruments/surgical technique as the modular, metal-backed system. This will improve the harmony between the various Freedom® systems and ensure all produce the same strong clinical results.

This document is a 510(k) Premarket Notification from the FDA regarding a Knee Joint Prosthesis, specifically the Freedom Total Knee System (All-poly Tibial Plate). It does not contain information related to an AI/ML (Artificial Intelligence/Machine Learning) powered medical device. Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study data for an AI/ML device.

The document discusses substantial equivalence for a physical medical device (a knee implant) based on mechanical properties, design comparisons, and adherence to existing predicate devices. It does not mention any software, algorithms, or AI components that would require a study with acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).

To provide the information you're asking for, I would need a document related to an AI/ML medical 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® Porous Tibial Base Plate and Cementless Femoral Components are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom® Porous Tibial Base Plate is a line extension of the Freedom® Total Knee System comprising of tibial base plate components for cemented or uncemented use in total knee arthroplasty. Freedom® Porous Tibial Base Plates are intended for use with existing, compatible Freedom® femoral and tibial liner components. Freedom® 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® 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.

The provided document is a 510(k) premarket notification for a medical device, specifically the Freedom® Total Knee System - Porous Tibial Base Plate. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria and performance analysis. Therefore, the information requested about acceptance criteria and a study proving the device meets them, typically found in a clinical trial report or a performance study for novel devices or software, is not directly applicable in the same way.

However, I can extract the information related to the non-clinical performance testing conducted to support the substantial equivalence claim. This testing serves as the "study" demonstrating that the device performs as intended and is similar to the predicate.

Here's an interpretation based on the provided text:

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

The document does not explicitly state numerical "acceptance criteria" for each test in the way a clinical trial might. Instead, the "acceptance" is implicitly defined by demonstrating that the subject device's performance is substantially equivalent to established performance standards or the predicate/reference devices. The "reported device performance" is summarized as the satisfactory completion of these tests.

2. Sample sized used for the test set and the data provenance

• Sample Size: The document does not specify the exact number of implants or test coupons used for each non-clinical test (e.g., how many tibial trays were fatigue tested). It mentions that "All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards."
• Data Provenance: The tests are non-clinical (laboratory/mechanical testing), not human clinical data. Thus, terms like "country of origin" or "retrospective/prospective" are not applicable. The data originates from laboratory testing conducted by or for the manufacturer (Maxx Orthopedics, Inc.).

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

This information is not applicable. The "test set" here refers to physical specimens (implants/coupons) for non-clinical testing, not patient data requiring expert interpretation or ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and requirements of the referenced ASTM and ISO standards.

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

This is not applicable as the tests are non-clinical, mechanical, and material evaluations performed against established standards, not clinical data requiring adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical knee implant, not an AI software or diagnostic tool used by human readers.

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

This 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 non-clinical performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced ASTM and ISO standards. For example, the acceptable number of cycles for fatigue testing is defined by ASTM F1800. For residual particles, the "ground truth" is the acceptable range established in the literature for the reference device, as evaluated against ASTM F1877.

8. The sample size for the training set

This is not applicable. The device is a physical knee implant. There is no "training set" in the context of machine learning or AI. The manufacturing process is validated, and the device's design is based on engineering principles and existing predicate designs, not a data-driven training set.

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

This is not applicable for the reasons stated above.

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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 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.

The Freedom® Total Knee System is intended for cemented and for 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.

This submission seeks the clearance of Titanium Nitride (TiNbN) coated version of previously cleared Stemmed PCK Femoral Component (non-coated version cleared in K131481) and Stemmed Tibial Base Plate (non-coated version cleated in K111785). The coated versions are now branded as Titan PCK Stemmed Femoral Component and Titan Stemmed Tibial Base Plate.

Both these components are manufactured from CoCrMo alloy and are coated completely with Titanium Niobium Nitride (TiNbN).

This document is a 510(k) premarket notification for a medical device, the Freedom® Total Knee System, and does not contain information about the development or testing of an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving an AI/ML device meets those criteria.

The document discusses the substantial equivalence of a new version of a total knee system (with a TiNbN coating) to previously cleared versions. The "performance testing" section refers to mechanical and biocompatibility tests for the physical knee implant components and their coating, not the performance of a software or algorithm. There is no mention of AI, machine learning, or any related technology.

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The Freedom® - 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 joint contour, 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 stock and soft tissue integrity are present.

The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Freedom® - TiNbN Coated Knee comprises of 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.

The provided text does not describe a study involving an AI/ML powered medical device or a diagnostic device that would require the establishment of ground truth by experts or a comparative effectiveness study with human readers.

Instead, the document is a 510(k) premarket notification for the Freedom® - TiNbN Coated Knee, which is a knee joint prosthesis. The acceptance criteria and the "study" (referred to as "Non clinical Performance data") described in the document relate to the physical and material properties of this medical implant, not to a diagnostic or AI-driven system.

Therefore, I cannot answer your request based on the provided text, as the information you've asked for (such as ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and AI effect size) is irrelevant to the type of device described in the document.

The document discusses:

• Device Type: Knee joint prosthesis (mechanical implant).
• Purpose of Submission: Demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.
• "Acceptance Criteria" / Performance Testing: Physical and material tests to ensure the implant meets safety and performance standards (e.g., wear resistance, coating adhesion, fatigue testing). This is not about diagnostic accuracy or AI performance.
• "Study" Data: Non-clinical (laboratory) performance data on the mechanical properties and coating characteristics of the knee implant.

If you have a document describing an AI/ML medical device, I would be happy to analyze it according to your criteria.

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The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• · Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

Note

· The Modular Shell, Uncemented Stem and Taper Uncemented Femoral Stem are intended for press-fit, uncemented use only.

· The Cemented stem is intended for cemented use only.

This 510k is intended to add a Modular Liner made from Vitamin E containing HXLPE (E-XLPE) to the Libertas™ - Hip Replacement System and Libertas™ Acetabular Hooded Liner cleared under K180973 and K183365, respectively. These Modular Liners are designed to be used with the Libertas components already cleared under K180973. These are available in different sizes i.e. MA, MB, MD, MF, MH, MJ, MK and different variants for each size Viz, neutral offset, "+4 mm offset", "Elevated wall", "10° Oblique", "15° Oblique" and "+4 mm offset 10° Oblique".

This looks like a 510(k) summary for a medical device called the Libertas™ E-XLPE Modular Liner, which is a component for hip replacement systems. The document states that the device is substantially equivalent to previously cleared predicate devices.

However, the provided text does not contain information about a study proving the device meets acceptance criteria in the way typically seen for AI/ML-powered medical devices. The "Non-clinical Performance data" section describes a series of mechanical and material tests for the physical hip implant component, not a clinical study or AI/ML performance evaluation.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance studies (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training set details, or ground truth establishment).

Here's an analysis of what is present in relation to "acceptance criteria" and "proof":

Analysis of Provided Information Regarding Acceptance Criteria and Proof

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical and material testing, which is the standard pathway for many Class II medical devices like this hip implant component. The "acceptance criteria" are implicitly tied to meeting the performance standards of these established predicate devices and the relevant ASTM/ISO standards.

The "study that proves the device meets the acceptance criteria" refers to the set of non-clinical bench tests listed.

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

Since this is a mechanical device, the "acceptance criteria" are the passing criteria for the referenced ASTM and ISO standards for properties like axial disassembly, offset pull-out, torque-out disassembly, impingement, range of motion, and material characteristics. The document states that these tests were "conducted to evaluate device function/mechanical performance and to demonstrate substantial equivalence," implying that the device met the acceptance criteria defined by these standards. However, the specific quantitative results of these tests and the exact thresholds for acceptance are not provided in this summary.

Implied Acceptance Criteria and Reported Performance (Based on available info):

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical bench tests on physical devices, not a test set of data like in AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to the results of the bench tests against established standards, not expert adjudication of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the non-clinical tests would be the measured physical and material properties meeting the specifications outlined in the referenced ASTM and ISO standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The Freedom® Primary PCK is designed to be used with the Freedom® Stemmed Tibial Components and as a part of the Freedom® Total Knee System, and is indicated for the following:

· Severe knee joint pain, loss of mobility 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

· Revision surgery where sufficient bone stock and soft tissue integrity are present

The Freedom® Primary PCK is intended for cemented use only. This device is for single use only.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Freedom Primary PCK" knee prosthesis does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

The document is a clearance letter for a physical medical device (a knee implant) and focuses on regulatory aspects like substantial equivalence to predicate devices, general controls, and indications for use. It does not mention any AI/ML components, performance metrics, or clinical study data related to an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

These details are typically found in the clinical study report or performance evaluation section of a submission for an AI/ML-driven device, which is not present in this regulatory clearance letter for a knee implant.

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The Libertas™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.

Total hip replacement is indicated for the following conditions:

• · Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Congenital hip dysplasia.
• · Acute traumatic fracture of the femoral head or neck.
• · Certain cases of Ankylosis.
• Dislocation of the hip.
• · Correction of functional deformity.
• · Revision of failed joint reconstruction or treatment.
• · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.

NOTE:

• · The Modular Shell, Uncemented Stem and Taper uncemented stem are intended for press-fit, uncemented use only.
• · The Cemented stem is intended for cemented use only.

The Libertas™ - Taper uncemented femoral stem is fabricated from Ti6Al4V - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial) and it is intended to be used with Libertas Femoral heads, previously cleared under K180973. The proximal portion of stem is coated with commercially pure Titanium with plasma spray method. Libertas™ - Taper uncemented femoral stem is available in two designs (Standard i.e. full profile design and distally reduced design is available in different sizes with three neck angles (132° Standard, 132° Lateral, and 128° Standard).

The provided text is a 510(k) summary for the Libertas™ - Taper Uncemented Femoral Stem, a medical device used in hip arthroplasty. This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing.

It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which would typically involve clinical performance metrics like sensitivity, specificity, or reader studies. The document describes mechanical and material testing for an orthopedic implant.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met, as the provided text pertains to a different type of medical device (a mechanical implant) and a different regulatory pathway (510(k) for substantial equivalence based on physical and material properties, not AI/ML performance).

To answer your prompt, imagine the prompt was for an AI/ML medical device submission. Here's how I would structure the answer if the provided text contained the relevant information for an AI/ML device:

Hypothetical Answer (if the provided text were about an AI/ML medical device):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: [Number, e.g., 500 cases]
• Data Provenance: [e.g., Retrospective cohort from hospitals in the USA and Europe]

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: [e.g., 3]
• Qualifications: [e.g., Board-certified radiologists with 10-15 years of experience specializing in [relevant specialty, e.g., musculoskeletal imaging]]

4. Adjudication Method for the Test Set

• Method: [e.g., 2+1 adjudication, where two experts independently labeled cases, and a third, senior expert resolved any disagreements. Or, consensus reading by all three experts.]

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• Was an MRMC study done? [Yes/No]
• Effect Size (if Yes): [e.g., Human readers showed an average improvement of 7.2% in sensitivity and a 12.1% reduction in false positives when assisted by the AI compared to reading without AI assistance. This translate to a statistically significant improvement in AUC of 0.05 (p

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