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510(k) Data Aggregation
(259 days)
The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The Indications for Use include: Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal® CR Knee Replacement System is intended for cemented use only.
The proposed iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tri- compartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system.. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
The ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical laboratory testing. No clinical studies or human-in-the-loop performance studies were performed to establish acceptance criteria or device performance in a clinical setting.
Here's a breakdown of the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, there isn't a direct "acceptance criteria" table with specific performance metrics and reported values in the way one might see for an AI algorithm or a diagnostic device. Instead, the acceptance was based on the device meeting the performance objectives of a series of bench tests, indicating it performed as safely and effectively as legally marketed predicate devices. The document states: "Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate devices for the proposed intended use." and "Results of the bench testing conducted demonstrate that the iTotal KRS is substantially equivalent to the Predicate Knee Systems."
The types of testing performed, which serve as the implicit "acceptance criteria" by demonstrating equivalence, include:
| Test Performed | Implied Acceptance Criteria / Objective | Reported Device Performance |
|---|---|---|
| Femoral Fatigue Testing | Demonstrate adequate fatigue life and strength of the femoral component, comparable to predicate devices. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| Kinematic Range of Motion Testing | Demonstrate functional range of motion consistent with predicate devices and expected physiological movement. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| Stability Characteristics Testing | Demonstrate satisfactory stability of the knee replacement system. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| Patello-Femoral Lateral Stability Testing | Demonstrate adequate lateral stability of the patello-femoral articulation. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| Contact Area and Surface Stress for the Patello-Femoral Articulation testing | Demonstrate acceptable contact mechanics (area and stress) in the patello-femoral joint. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| Tibial-Femoral Contact Areas and Stress Testing | Demonstrate acceptable contact mechanics (area and stress) in the tibial-femoral joint. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| Modular Assembly and Disassembly Characteristics of the iTotal Tibial Plateau Testing | Demonstrate proper and secure assembly/disassembly of modular components. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
| UHMWPE Characterization | Characterize the material properties of the Ultra-High Molecular Weight Polyethylene (UHMWPE) components, ensuring they meet specifications. | Results are not explicitly quantified in the provided text, but the overall conclusion is that the testing demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a medical device (knee replacement system) and relies on non-clinical bench testing, not a test set of patient data/images. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The "samples" would refer to the physical devices or components subjected to laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "ground truth" expert review of a test set as this was a physical device, not a diagnostic or AI-driven system.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication in the context of this device submission.
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-assisted diagnostic device, nor was an MRMC study conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical knee replacement device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the typical sense for a diagnostic device. The "ground truth" for this device's safety and performance was established through engineering principles, material science, and mechanical testing standards relevant to orthopedic implants. The performance was compared to established predicate devices using these physical and mechanical tests.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI algorithm.
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