(34 days)
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.
| Acceptance Criterion (Demonstrating Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Tibiofemoral Range of Motion (ASTM F2083 6.2.3): Equivalent maximum flexion angle. | Simulated Computer-Aided-Design software determined the range of motion (maximum flexion angle) of the Subject Device was equivalent to the Predicate Device. |
| Tibiofemoral Constraint Characterization (ASTM F1223 and F2083): Satisfy preestablished benchmark performance in comparison to the Predicate Device for anterior (A/P), medial/lateral (M/L), and internal/external constraint of the articular surface through various degrees of flexion. | The results satisfied the preestablished benchmark performance in comparison to the Predicate Device. |
| Tibiofemoral Contact Area and Contact Pressure (ASTM 2083 6.2.2): Equivalent throughout a range of motion compared to the Predicate Device. | The contact area and contact pressure was found to be equivalent throughout a range of motion compared to the Predicate Device. |
| Material: Identical to current Freedom UC tibial insert. | The material... of the MC tibial insert are identical to the current Freedom UC tibial insert. |
| Locking Tab Geometry: Identical to current Freedom UC tibial insert. | The... locking tab geometry of the MC tibial insert are identical to the current Freedom UC tibial insert. |
| Tibial Insert-Tray Disassembly Forces: Considered the same as for the MC tibial insert due to identical material and locking tab geometry. (No specific test reported, but inferred equivalence) | Given the identical material and locking tab geometry, disassembly testing is needed [to confirm, but implies expectation of equivalence]. |
| Sizing and Compatibility with Freedom CR Femoral Components: Same as for existing UC tibial inserts and femoral components. | The sizing and compatibility of the MC tibial inserts and the Freedom CR femoral components is therefore the same as for the existing UC tibial inserts and femoral components. |
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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.