(49 days)
A) Osteoarthritis
B) Rheumatoid arthritis with severe hip pain and limited joint motion
C) Avascular necrosis
D) Traumatic arthritis
E) To be used in conjunction with a Biopro femoral stem and a 28mm or 32mm Biopro ceramic or cobalt chrome head.
The Providence acetabular shell is manufactured from 6-4 Eli Titanium. It is porous coated and contains screw holes to allow for additional fixation. The acetabular component houses 28mm and 32mm ID inserts that are either neutral or lipped. It is available in eight sizes: 46mm, 48mm, 50mm, 52mm, 56mm, 56mm, 58mm, and 60mm.
The Providence acetabular insert is manufactured from UHMWPE. It is designed to snap-fit into the acetabular cup. The acetabular cup will accept 28mm and 32mm heads. It is available in both a neutral and hooded variety. The insert is available in sizes ranging from 46mm to 60mm.
The Providence screw plug is manufactured from 6-4 Eli Titanium. It is used to plug the threaded impaction hole in the acetabular shell.
The provided text describes the Providence Cup System, a hip prosthesis, and does not contain information about acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications. The document is a 510(k) summary and an FDA clearance letter, which primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against specific performance criteria.
Therefore, I cannot fulfill your request for an acceptance criteria table, study details, sample sizes, ground truth information, or MRMC study results because this information is not present in the provided text. The document only lists the indications for use of the device and its equivalence to other marketed hip systems.
§ 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.