(26 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.
The AcuMatch C-Series Femoral component is intended to be used with bone cement.
C-Series Femoral Stem Components are made from Cobalt Chromium Molybdenum alloy forged per ASTM F 799-96. The components have a satin finish and are intended for cemented applications only. The stems have a collar to enhance cement pressurization and stress transmission to the medial femoral neck. There is a proximal to distal taper and trapezoidal cross-sectional geometry in the distal region. C-Series stems may be used with optional distal PMMA centralizers to ensure central stem placement.
The provided text is a 510(k) summary for a medical device (Exactech® AcuMatch™ Integrated Hip System C-Series Cemented Femoral Component - Size 0). It details the device's classification, intended use, description, and comparison to predicate devices for substantial equivalence.
However, it does not contain any information about acceptance criteria for performance metrics related to an AI/ML algorithm or a study proving that such a device meets those criteria.
The "Performance Data Summary" section only states: "Three point bending fatigue testing showed that the strength of the C-Series size 1 components is sufficient to support expected in vivo load applications." This refers to biomechanical testing of a physical implant, not the performance of a software algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and an AI/ML study from the given text. The text describes a traditional hardware medical device, not an AI-powered one.
§ 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.