(29 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, 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 ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper.
- 12/14 P-Series model has a plasma-spray surface enhancement.
- 12/14 L-Series model has a corundum finish.
Both models have a hydroxyapatite (HA) coating option. The femoral stems are intended for press-fit fixation. Models without the HA coating may be used with bone cement at the discretion of the surgeon.
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device (Exactech AcuMatch 12/14 Press-Fit Femoral Stems) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about specific performance acceptance criteria, study designs to prove meeting those criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for such studies.
The document states that the conclusion drawn from empirical testing and engineering analyses is that the components would be adequate for anticipated in vivo use, and that this leads to the conclusion of substantial equivalence. However, it does not detail the specific acceptance criteria or the study designs and results used to arrive at this conclusion.
§ 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.