(85 days)
The Revision Hip System stems are single use devices. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection of the hip; and correction of deformity.
The Revision Hip System stems are single use devices. The components of the Revision Hip System have the same function as other hip systems designed for cemented and cementless fixation.
The provided text describes a medical device, the "Smith & Nephew Orthopaedics Revision Hip System," and its indications for use. However, it does not contain any information about acceptance criteria, device performance studies, or details regarding AI algorithms, ground truth, or expert involvement.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or provide details about studies, sample sizes, data provenance, expert qualifications, or AI-related aspects.
The text only states that "The engineering analyses of these devices was acceptable and the components of the Revision Hip System should perform as well as other hip systems." This is a very general statement and does not provide quantifiable acceptance criteria or study results.
§ 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.