(173 days)
The EnduRo Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.
Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.
The EnduRo Knee System is intended for cemented use only.
The EnduRo Knee System is a cemented prosthesis with a rotating hinge design. The femoral component, tibial plateau and extension stems are manufactured from CoCrMo. The tibial "gliding surfaces" and patella are manufactured from UHMWPE. The tibial mask is made from PEEK Optima® (LT1). The axial sleeve and femoral bushing components are produced from PEEK Optima® (LT1CA30). The system is made up of numerous components available in various sizes. The femoral, tibial plateau, and extension stems are also available with a ZrN (zirconium nitrate) coating. All components are sterile and for single use only.
The provided text describes the EnduRo Knee System, a total knee replacement system, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of diagnostic AI/ML devices.
The document is a 510(k) summary for a medical device (a knee prosthesis), not an AI/ML diagnostic. Therefore, the requested information categories (acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not relevant to this type of device submission and are not present in the provided text.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the
EnduRo Knee Systemto existing legally marketed predicate devices (NexGen Complete Knee Solution Rotating Hinge Knee and Aesculap Columbus REVISION Knee System). - Device Description: Detailing the components and materials of the
EnduRo Knee System. - Indications for Use: Specifying the medical conditions for which the device is intended.
- Technological Characteristics: Stating that the device has similar shapes, sizes, and materials as the predicate devices.
- Performance Data: Listing a series of engineering and mechanical tests performed to support substantial equivalence. These tests include:
- Range of Motion
- Wear testing
- Femoral Endurance Properties
- Endurance Properties of Modular Femoral Stem Assembly
- Tibial Tray Endurance Properties
- Endurance Properties of the rotating axis component in A/P direction
- Endurance Properties of the Modular Tibial Stem Assembly
- Varus-Valgus Endurance Properties
- TibioFemoral Contact Area/Stress at Different Angles of Flexion
- PatelloFemoral Lateral Subluxation Resistance
- PatelloFemoral Contact Area/Stress at Different Angles of Flexion
Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and studies in the context of AI/ML diagnostic devices based on the provided text. The document pertains to a mechanical orthopedic implant, for which "acceptance criteria" and "studies" are typically defined by biomechanical standards and in-vitro testing, rather than clinical performance metrics with ground truth established by experts.
§ 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.