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The Global Modular Replacement System (herein referred to as the GMRS) is intended to be used with the components of the Howmedica Osteonics Modular Replacement System (MRS), the Howmedica Osteonics Modular Rotating Hinge Knee System (MRH), and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System (KRH) in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMRS may be used together, or with the components of the MRS, in replacement of the total femur. Indications and contraindications for this type of replacement are listed below:

Indications

Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

The GMRS is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of Howmedica Osteonics' Modular Rotating Hinge Knee, Kinematic Rotating Hinge Knee, and/or the Modular Replacement System. There are three modules of the GMRS:

• Proximal Femoral Module
• Distal Femoral/Proximal Tibial Module
• Total Femur

Each of these modules is comprised of different components. The modules, and their individual components, are described below:

Proximal Femoral Module

The Proximal Femoral Module of the GMRS contains the following components:

• Proximal Femoral Components
• Extension Pieces
• GMRS Press Fit Stems with PureFix™ HA

Distal Femoral/Proximal Tibial Module

The Distal Femoral/Proximal Tibial Module of the GMRS contains the following new components:

• Distal Femoral Components
• Extension Pieces (as described in the section above)
• Small bushings
• Small Axle
• Proximal Tibial Component
• Proximal Tibial Inserts
• Proximal Tibia Rotating Components

Total Femur

Replacement of the total femur is accomplished by combining the following components of the GMRS:

• Proximal Femoral Component
• Extension Pieces
• Connection Pieces
• Distal Femoral Component (with appropriate bushings, axle, etc.)
• Proximal Tibial Component (with appropriate tibial rotating component, tibial insert component)

The provided document is a 510(k) Summary for the Global Modular Replacement System (GMRS). It discusses the device's intended use, indications, contraindications, and describes its components, as well as listing equivalent predicate devices.

However, it does not contain any information about acceptance criteria or specific studies that quantify the device meets acceptance criteria. The document states that "Testing was presented to support a claim of substantial equivalence to the predicate devices," but it does not detail what tests were performed, what the acceptance criteria for those tests were, or what the reported device performance was.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone study was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document focuses on regulatory classification, intended use, and equivalence to existing devices, common for a 510(k) submission, rather than detailed performance study results.

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