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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 Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.

• Prime AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes: -
    • Solid (46mm-68mm outer diameter)
    • Quad (42mm- 68mm outer diameter) .
  • Sterilization: Gamma Sterilization -
• DYNASTY® AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes:
    • o Standard (46mm- 76mm outer diameter)
    • Primary (46mm-68mm outer diameter) o
    • Revision (46mm-76mm outer diameter) o
  • Sterilization: Gamma Sterilization -

The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, specifically Prime and DYNASTY® Additive Manufacturing Shells, which are hip implants.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria. The document details the substantial equivalence of the hip implants to legally marketed predicate devices based on non-clinical bench testing, material properties, and design similarity, not performance metrics for an AI algorithm.

Here's why the requested information cannot be provided from the given text:

• No AI/ML Component: The device described is a physical orthopedic implant. There is no mention of any AI or machine learning algorithm.
• No "Performance" in the AI/ML Sense: The "performance" discussed in the document relates to mechanical properties (tensile strength, fatigue, deformation, corrosion, shear strength, etc.) and biocompatibility of the implant, not the diagnostic or predictive performance of an algorithm.
• No Test Set/Training Set: These concepts are specific to AI/ML model development and evaluation. The document discusses "worst-case constructs" for physical testing and "predicate nonclinical test results," which are entirely different.
• No Experts for Ground Truth/Adjudication: Ground truth establishment and adjudication by experts are crucial for evaluating AI/ML models in medical imaging, but this is irrelevant for a physical implant.
• No MRMC Study: A Multi-Reader Multi-Case study is for evaluating human performance, often with or without AI assistance, in interpreting medical data. This device is not an interpretation tool.
• No Standalone Algorithm: This phrase applies to an AI algorithm operating without human intervention for diagnostic or predictive tasks.

In summary, the provided document does not describe an AI/ML device, and thus, the questions posed (which are relevant to AI/ML device evaluation) cannot be answered from this text.

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