(64 days)
The Movation Knee System is Indicated For: 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 to be used for cemented applications.
The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.
The provided document describes a medical device, the "Movation Highly Cross Linked Vitamin E Tibial Insert," and its substantial equivalence to predicate devices, not a study evaluating a device's performance based on specific acceptance criteria as you'd typically find for AI/software-as-a-medical-device (SaMD).
This document is a 510(k) Premarket Notification summary for an orthopedic implant. It focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through non-clinical testing (mechanical, physical, chemical, and wear testing) and comparisons of design and materials. It explicitly states "Clinical Testing: None provided."
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of an AI/SaMD, as this document does not contain that type of information.
Here's what I can extract from the provided text, highlighting why the requested information for acceptance criteria and a "study" (in the AI/SaMD sense) isn't present:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of device are generally related to demonstrating substantial equivalence to predicate devices through various non-clinical engineering and material tests. For example, ensuring mechanical properties (tensile strength, impact resistance, crack propagation) fall within acceptable ranges and are comparable to predicate devices.
- Reported Device Performance: The document reports results for various non-clinical tests (Tensile, Small Punch, Izod Impact, crack propagation, Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Melting Temperatures, Delta H, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Polydispersity Index, Lamallae Thickness, Free Radical Concentration, Vitamin E Concentration, Vitamin E Consolidation, Vitamin E Elution/Extraction, Trans-vinylene Index, tibial insert peel-out strength, wear testing, and biocompatibility). The document states, "All testing has demonstrated the device is substantially equivalent to the predicate devices." This is the ultimate "performance" reported in this context – equivalence to existing devices, not a standalone clinical performance against a ground truth.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This document describes non-clinical laboratory testing (material characteristics, mechanical properties, wear, biocompatibility). These tests typically use material specimens or prototypes, not clinical "test sets" of patient data. There is no concept of country of origin for "data" in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This relates to clinical performance evaluation, which was not performed or submitted.
4. Adjudication Method for the Test Set:
- Not applicable. This relates to clinical performance evaluation, which was not performed or submitted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a premarket notification for an implantable medical device, not an AI or diagnostic software. Clinical studies, especially MRMC studies, are not mentioned and are often not required for 510(k) clearances if substantial equivalence can be demonstrated through other means (like non-clinical testing for implants). The document explicitly states: "Clinical Testing: None provided."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is for a physical medical device (tibial insert), not an algorithm or software.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" implicitly refers to established engineering standards, material specifications, and performance characteristics of the predicate devices. The testing confirmed the new device met these criteria and was comparable. There's no biological or clinical "ground truth" (e.g., pathology, outcomes data) used in this submission.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set or associated ground truth.
In summary, the provided document details a 510(k) submission for a physical orthopedic implant. Its "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through extensive non-clinical (laboratory and materials) testing, not through clinical studies of performance against ground truth, which would typically be included for an AI/SaMD product.
§ 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.