(90 days)
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:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method for the test set: This information is not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
- If a standalone study was done: This information is not present.
- The type of ground truth used: This information is not present.
- The sample size for the training set: This information is not present.
- 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.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.