(271 days)
The Hinged Knee is a tri-compartmental prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components. It's intended use is to allow replacement of the knee joint in which significant bone loss and/or ligamentous deficiencies have occurred due to tumors, trauma, infection, revision or connective tissue disorders. The Hinged Knee provides joint stability when any or all of the following structures are non-functional: MCL, LCL, PCL, ACL and the iliotibial band.
The Hinged Knee is a tri-compartmental prosthesis of the total condylar type. The system consists of femoral, tibial and patellar components.
This document is a 510(k) premarket notification for a medical device called the "Hinged Knee," a total knee replacement prosthesis. It is a regulatory approval document from the FDA, not a study report detailing acceptance criteria and performance data.
Therefore, I cannot provide the requested information because the input text does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
The document primarily focuses on:
- Device Description: What the Hinged Knee is (a tri-compartmental prosthesis for total knee replacement).
- Intended Use/Indications For Use: Whom it's for (patients with significant bone loss/ligamentous deficiencies due to various conditions) and what it does (provides stability when certain ligaments are non-functional).
- Predicate Device Comparison: Stating that it has comparable features to predicate devices (same indications, materials, similar geometry).
- FDA Clearance: The FDA's decision to clear the device for marketing based on substantial equivalence to pre-1976 devices, with specific limitations regarding its use (cemented use only, minimum tibial insert thickness).
- Regulatory Information: References to FDA regulations and responsibilities.
There is no mention of:
- Acceptance criteria
- Device performance metrics or data
- Study design (test/training sets, sample sizes)
- Expert involvement for ground truth
- Adjudication methods
- MRMC studies
- Standalone algorithm performance
- Type of ground truth (pathology, outcomes, etc.) for any data
§ 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.