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510(k) Data Aggregation
(74 days)
RHS ACETABULAR COMPONENT
OSTEOARTHRITIS
RHEUMATOID ARTHRITIS
TRAUMATIC ARTHRITIS
WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE
INTENDED FOR NON-CEMENTED USE SINGLE USE ONLY
The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.
This document is a 510(k) summary for a medical device (HHS Acetabular Component), not a study report for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details that are typically found in such studies.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other requested information as it is not present in the provided text.
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