(89 days)
The Salvage/Oncology Hip and Total Femur System is designed to replace the either the encire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions. The device requires the use of a modular head, acetabular component and when used as a total femur replacement a Finn Knee tibial component. All components of this system are indicated for use with bone cement.
The Salvage/Oncology Hip and Total Femur System is designed to replace either the entire femur or a large portion of the proximal femur in cases of severe bone loss most commonly due to oncological diagnoses or limb salvage following multiple revisions or trauma. When total femoral replacement is indicated, a proximal 1/3 hip component, a diaphyseal shaft and Finn Knee components are necessary. When the device is used for hip replacement, a proximal 1/3 hip component and a femoral stem are required. Two styles of the proximal 1/3 hip component are available, the Letson Modular Proximal and the Finn Proximal Component. Both devices have left and right configurations to ensure proper alignment of components. The proximal 1/3 hip component devices can be used as a modular hip stem with a femoral stem in cases where large proximal femur bone resection is necessary but the knee joint is not involved. The stems compatible with the proximal components are the Finn Knee Modular Segmental Stem Components. The diaphyseal component is a shaft which connects a proximal 1/3 hip component to a knee component when the device is used for total femur replacement. All components of this system are indicated for use with bone cement.
This document is a 510(k) premarket notification for a medical device, the Salvage/Oncology Hip and Total Femur System. It describes the device, its intended use, and the FDA's determination of substantial equivalence to previously marketed predicate devices.
There is no information in the provided text about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is primarily focused on the regulatory clearance process, specifically the FDA's finding of "substantial equivalence" based on comparisons to existing predicate devices. This type of regulatory submission typically does not include detailed performance studies with acceptance criteria in the way a clinical trial or performance validation study for a novel device would.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.