(190 days)
Indications for use of the SHP Hip System include: 1) non inflammatory joint disease including ostecarthritis and avascular necrosis. 2) theurnatoid arthritis. 3) correction of functional deformity, 4) revision of failed joint reconstruction, and 5) treatment of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement which are unmanageable using other techniques.
The device is a single use implant intended for use with bone cement.
The Scientific Hip Prosthesis or SHP Hip System is composed of an anatomic cobaltchromium alloy femoral stem with a modular head component and an all polyethylene acetabular component. The femoral component is anatomically proportioned, with sizing developed based on a computer analysis of 300 cadaver femurs to achieve a model of actual anatomic variation. The design was determined by Numerical Shape Optimization (NSO) and has been shown to reduce normal and shear stresses in the cement mantle and at the implant/cement/bone interface as compared to other femoral components in an FEM analysis. The proximal surface is roughened to facilitate greater cement adherence. PMMA spacers assist in placement of the stem. The stom is available in seven sizes with left and right configurations. The acetabular component features pegs to ensure a more uniform cement mantle and is available in seven outer diameters.
This document describes a medical device, the SHP Hip System, which is a hip joint prosthesis. It outlines the device's components, indications for use, potential risks, and claims of substantial equivalence to other devices on the market.
However, the provided text does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters you've requested.
The "Summary of Safety and Effectiveness" section is a regulatory filing document (likely a 510(k) summary) and its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed performance study with acceptance criteria as one would find in a clinical trial report or a study evaluating an AI/software device.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. To answer your questions, I would need a document detailing a performance study that evaluates the SHP Hip System against predefined acceptance criteria.
§ 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.