(79 days)
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. This system is intended to be used for cemented applications.
The Movation Knee System is a tri-compartmental posterior stabilized knee for cemented applications. The system is comprised of four primary components: Femur, Tibial Insert, Tibial Baseplate, and Patella. The system is intended to treat patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. The design of the knee system is a total condylar design, increasing sagittal conformity and stability. The post and cam of the posterior stabilized design are crucial to inducing femoral rollback and providing resistance to tibial subluxation, substituting the function of the absent PCL. The tibial post in combination with the femoral cam is designed to encourage femoral roll-back on the tibia and allow clearance for deep flexion.
The Movation Knee System is a medical device and therefore the acceptance criteria are not based on performance metrics like accuracy, sensitivity, or specificity, but rather on regulatory compliance and substantial equivalence to predicate devices. The study proving the device meets acceptance criteria is a non-clinical study involving functional testing, rather than a clinical study with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Implant performance for anticipated in vivo loading via various constraint and fatigue tests. | Functional testing was conducted in compliance with FDA guidance ("Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA") to verify that the implant performance would be substantially equivalent to predicate devices. (Specific performance metrics are not provided, only the statement that equivalence was verified). |
| Design/Material Equivalence: Components (Femur, Tibial Baseplate, Tibial Insert, Patella) are comparable in design and materials to predicate devices. | Femur: Asymmetric anterior flange (similar to Optetrak), total condylar design with post and cam articulating geometry (similar to Optetrak), anatomic component (similar to Foundation PS Knee). |
| Baseplate: Asymmetric perimeter, finned or trapezoid keel (similar to Foundation and Optetrak, respectively). | |
| Posterior Stabilized Insert: Symmetric component (similar to Foundation PS and Optetrak PS Systems). | |
| Patella: Domed geometry with three pegs (similar to Optetrak), same diameters as Optetrak and Foundation (MTS). | |
| Materials: UHMWPE for Insert and Patella; CoCrMo for Baseplate and Femur (all similar to predicate devices). | |
| Packaging and Sterilization Equivalence: Method of packaging and sterilization is comparable to predicate devices. | Packaged and sterilized using the same method as the 3DKnee System. Sterilization by gamma radiation (minimum 25 kGy) to achieve a Sterility Assurance Level (SAL) of 10^-6. |
| Regulatory Compliance & Substantial Equivalence: Adherence to FDA regulations and demonstration of substantial equivalence to legally marketed predicate devices. | The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. (This is the ultimate acceptance criteria for a 510(k) submission). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" here refers to the physical device components undergoing non-clinical bench testing. The document doesn't specify the number of individual implants or components subjected to each functional test.
- Data Provenance: The data provenance is from non-clinical functional testing conducted by the manufacturer, Encore Medical, L.P. The location of the testing is not specified, but it's internal company testing for regulatory submission. It is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a medical device 510(k) submission, the "ground truth" for non-clinical testing is typically defined by industry standards, engineering specifications, and FDA guidance documents. There is no mention of external human experts establishing ground truth for the functional tests themselves. The FDA reviewers (Division of Surgical, Orthopedic, and Restorative Devices) are the experts who evaluate the submission against regulatory requirements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review by multiple human readers. For non-clinical bench testing, the results are objectively measured against pre-defined engineering criteria, and therefore, an adjudication method for disagreements among human reviewers is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: None provided."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Movation Knee System is a physical medical device (an orthopedic implant), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was established by:
- FDA Guidance: "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."
- Industry Standards: Implicitly, as functional testing is conducted to verify performance against "anticipated in vivo loading." While not explicitly named, these would refer to relevant ISO or ASTM standards for implant testing.
- Predicate Device Performance: Performance that demonstrates "substantial equivalence" to the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML 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 device.
§ 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.