Search Results

• 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.

Ask a specific question about this device

The Freedom® Total Knee System consists of a femoral component, poly tibial component, and a patellar component. The Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:

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

The Freedom® Total Knee System is comprised of a femoral component (cruciate retaining and posterior stabilizing), all-poly tibial component and a patellar component as described below.
The Freedom® 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® Total Knee System's Femoral Component is made of Cobalt-Chromium-Molybdenum and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection.
The Freedom® Total Knee System's Tibial baseplate component is fabricated from ultra high molecular weight polyethylene 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. The Freedom® Total Knee System Patellar component is available in a symmetric design fabricated from industry standard UHMWPE (ASTM F648). Testing of the Freedom® Total Knee System has been performed out to 135 degrees which demonstrates high flexion of the total knee device.

The provided text describes the 510(k) summary for the Maxx Orthopedics Freedom® Total Knee System. This document outlines the device's characteristics, intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, AUC). Instead, the performance testing section refers to mechanical and material characteristics.

Therefore, I cannot populate the requested table and answer the study-related questions as the information is not present in the provided document.

Here's why and what can be extracted:

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

• Cannot be created based on the provided text. The document states: "Evaluations were performed to determine the material and mechanical characteristics of the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. This testing shows that the Freedom® Total Knee System functions as intended and is safe and effective for its intended use."
• This indicates that performance testing was done, but the specific acceptance criteria (e.g., maximum wear rate, minimum fatigue life, specific range of stability) and the reported device performance against those criteria are not detailed in this summary. It only states that the device "functions as intended" and is "safe and effective."

Regarding the study that proves the device meets the acceptance criteria:

The document mentions "Performance Testing" was conducted to determine the material and mechanical characteristics. However, it does not provide the specific details required for the following requested points:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not provided. The nature of the "test set" for mechanical and material characteristics would typically be specific components or full implant assemblies, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. For mechanical testing of an orthopedic implant, ground truth is established through standardized engineering tests, not expert human assessment in the way it's done for AI/ML diagnostic tools.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. This is relevant for human-interpreted diagnostic findings, not 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:
* Not applicable. This device is a total knee replacement system, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a total knee replacement system; there is no algorithm in this context.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* For material and mechanical properties, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM standards for material properties, ISO standards for wear testing, fatigue testing parameters). The document references "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," which would outline these standards.

8. The sample size for the training set:
* Not applicable/Not provided. There is no "training set" in the context of mechanical testing for a conventional medical device like a knee implant.

9. How the ground truth for the training set was established:
* Not applicable/Not provided. See point 8.

In summary, the provided 510(k) pertains to a physical medical device (a total knee system) and its mechanical/material performance, not an AI/ML-based device. Therefore, many of the requested criteria and study details, which are typical for AI/ML device evaluations, are not present or applicable to this document.

Ask a specific question about this device