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The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions:

• 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity;

The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.

The purpose of this submission is to seek clearance for the Evolution® Total Knematic Alignment Instrumentation and Technique. The instruments consist of resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation. The Kinematic Alignment technique is to duplicate the pre-arthritic native joint line. Unlike Mechanical Alignment where the focus is placed on making a perpendicular tibial resection, non-anatomic distal and posterior femoral cuts, and ligament releases if needed, Kinematic Alignment prioritizes the femoral cuts to replicate the native joint line. The Kinematic Alignment technique compensates for wear on the prearthritic joint line and strives for natural ligament tension.

The Evolution® Kinematic Alignment surgical technique is used with the following 510(k)-cleared knee components. No changes to the compatible Evolution® implants are being presented in this 510(k). The compatible implants are axactly the same as the previously cleared Evolution® implants.

• · Evolution® MP Total Knee System, K093552
• · Evolution® MP Total Knee System, K102380
• · Evolution® MP CS/CR Porous Femur, K140735
• · Evolution® Biofoam® Tibial Base and Evolution Biofoam Modular Keels, K152298
• · Evolution® Revision Tibia Base System, K162026
• · Evolution® Biofoam Tibial Base with Biofoam® Additive Manufacturing, K170288
• · Evolution® Stemmed CS Femur, K182125
• Evolution® NitrX™ Medial-Pivot Knee, K182251

The provided text is a 510(k) summary for the MicroPort Orthopedics Inc. "Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique." It outlines the regulatory clearance process for a new surgical technique and associated instrumentation, not an AI/ML-based medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this document.

This document describes a medical device (surgical instrumentation for knee replacement) that falls under traditional medical device regulations, where clearance is typically based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing and comparison of technological characteristics. There is no mention of software with AI/ML components requiring performance evaluation against specific metrics like sensitivity, specificity, or accuracy, nor is there any data related to how human readers improve with AI assistance.

The document explicitly states: "Not applicable. Clinical data were not necessary for the subject device." and "The nonclinical analyses and validations demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices." This confirms that the clearance was based on non-clinical engineering and design validation, not clinical performance studies involving outcome data or expert consensus for AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt's questions are tailored for AI/ML medical devices, which this document does not describe.

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The indications for use are:

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis

B. Failed osteotomy or unicompartmental replacements

C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists

D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement

E. The porous coated (CoCr beads with Titanium) components may be used with or without cement

The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.

The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.

The provided text describes the regulatory clearance for the "Consensus Knee System with TiNbN" and discusses its substantial equivalence to predicate devices, primarily focusing on the addition of a TiNbN coating. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

The text is a 510(k) summary for a medical device (knee prosthesis), which focuses on demonstrating substantial equivalence to existing devices. The "tests" mentioned are non-clinical, primarily material and mechanical tests (biocompatibility, wear performance, fatigue, range of motion) conducted for the physical implant and its new coating, not for any AI or software component.

Therefore, I cannot provide the requested information, as the input document does not contain details about:

• Acceptance criteria for AI/software performance.
• A study validating AI/software performance.
• Sample sizes for test sets (in the context of AI/software).
• Expert involvement in establishing ground truth for AI/software.
• Adjudication methods for AI/software test sets.
• MRMC studies.
• Standalone AI algorithm performance.
• Types of ground truth for AI/software.
• Training set sample sizes or ground truth establishment for an AI/software component.

The document is about a physical medical device (a knee implant), not an AI/software device.

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