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The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: •Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis. · Avascular necrosis of femoral condyle. ·Post traumatic loss of joint configuration. ·Primary implantation failure. Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

The GMK® HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation of a constrained prosthesis. The GMK® HINGE knee system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability · Considerable loss of function of the knee joint · High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation - · Failure of a primary prosthesis (e.g. infection, loosening) - · Former revision arthroplasty - Post traumatic loss of joint configuration - · Avascular necrosis of femoral condyle. Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws. When a GMK® HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

The GMK Revision & Hinge Extension - TiNbN Coating is a Medacta GMK line extension to provide a larger product offering. The subject devices are designed for cemented use in total knee arthroplasty procedures. The GMK Revision & Hinge Extension - TiNbN Coating includes the following implants: . GMK Revision Femoral Component TiNbN coated, Standard and Posterior Stabilized, Left and Right. Sizes from 1 to 6 - GMK Revision tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6 - GMK Revision SC peg TiNbN coated, sizes from 10 to 26 mm ● GMK Hinge Femoral Component TiNbN coated, Left and Right, Sizes from 1 to 6 ● GMK Hinge tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6 - GMK Hinge post extension TiNbN coated, sizes from 10 to 26 mm - Screwed tibial augmentations Ti6A14V, from 0 to 6 for thicknesses 5 and 10 and sizes from 1 to 6 for thicknesses 15 and 20 mm - Femoral posterior augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 5, 8, and 10 . mm - Femoral distal augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 8, 12, 16 and 20 mm The GMK Revision & Hinge - TiNbN Coating implants, both femoral components and Tibial trays, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery - Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating. The external and internal bushes, inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) according to ISO 5834-2:2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms. The GMK Revision SC peg & Hinge post extension, as well as the GMK hinge post and internal pivot inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-12:2019 Implants for Surgery -Metallic Materials-Part 12: Wrought cobalt-chromium-molybdenum Alloy with Titanium Niobium Nitride (TiNbN) coating. The GMK Revision & Hinge augmentations, both tibial and femoral, are manufactured from Ti6A14V per ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

This document (a 510(k) clearance letter) describes a medical device, the GMK Revision & Hinge Extension - TiNbN Coating, which is a line extension of an existing total knee arthroplasty system. It details the device's characteristics, indications for use, and a comparison to predicate devices, stating it is substantially equivalent. However, this document is a regulatory submission for a physical medical device (knee implant components), not an AI/ML-driven device or diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study methodologies (like sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance), and training set details are not applicable to this type of device clearance. The document focuses on demonstrating physical and material equivalence and performance through non-clinical (mechanical, wear, biocompatibility) testing, not on evaluating algorithmic performance on image data.

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

• Acceptance Criteria & Reported Performance: The document provides "Performance Data" which lists various non-clinical (laboratory) tests performed on the device components (e.g., wear behavior, mechanical performance, modular connection evaluations). However, it does not present these in a table with specific quantitative acceptance criteria or detailed results in the way one would for an AI/ML diagnostic's performance metrics (e.g., sensitivity, specificity, AUC). The conclusion simply states that testing was done "in support of a substantial equivalence determination."
• Sample Size (Test Set) and Data Provenance: Not applicable. These relate to studies on a test dataset for an AI model. For this device, "testing" refers to physical product testing (e.g., a certain number of prosthetic components subjected to specified mechanical loads).
• Number/Qualifications of Experts (Ground Truth): Not applicable. This pertains to human interpretation of data for AI model validation.
• Adjudication Method: Not applicable. This is for resolving discrepancies in expert labeling of data.
• MRMC Comparative Effectiveness Study: Explicitly stated: "No clinical studies were conducted." Therefore, no MRMC study or effect size data exists.
• Standalone Performance: Not applicable. This refers to the performance of an algorithm without human intervention. The device is a physical knee prosthesis, used by surgeons.
• Type of Ground Truth: Not applicable for an AI/ML context. For this medical device, the "ground truth" for its performance is established through engineering standards, mechanical testing protocols, and material science specifications.
• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Physical medical device (knee implant components), not an AI/ML system.
• Regulatory Pathway: 510(k) Premarket Notification, claiming substantial equivalence to predicate devices.
• Performance Data (Non-Clinical): Various laboratory tests were conducted, including:
  • TiNbN coated Femoral Components Wear Behavior
  • Evaluation of modular tapered connection
  • Femoral Modular Connection
  • TiNbN Coating Excessive Ions Release
  • TiNbN coated Femoral Component Mechanical Performances
  • TiNbN coated Tibial Trays Mechanical Performances
  • TiNbN coated Tibial Trays Connection with the insert
  • Tibial Tray Modular Connection
  • Tibial Modular Connection
  • GMK Revision TiNbN coated SC Peg Mechanical Performances
  • GMK Hinge TiNbN coated Post Extension Mechanical Performances
  • Ti6A14V Femoral Augmentations Validation
  • Posterior Wedge Screw Design Validation
  • Ti6Al4V Tibial Augmentation Validation
  • Pyrogenicity testing (Bacterial Endotoxin Test, Pyrogen test)
  • Biocompatibility assessment.
• Clinical Studies: "No clinical studies were conducted."
• Ground Truth: For this type of device, ground truth is established through adherence to biomechanical and material standards (e.g., ISO standards for materials, recognized test protocols for wear and mechanical strength).
• Acceptance Criteria (Implied): Substantial equivalence to predicate devices and meeting established engineering and material standards for safety and performance (e.g., ISO standards for wear, strength, biocompatibility). Specific quantitative acceptance criteria are not detailed in this clearance letter but would be present in the full 510(k) submission.

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