Search Results

Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; congenital dysplasia; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic dysplasia; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip and correction of deformity.

Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior wall deficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use.

The Contour HA Coated Reconstruction Ring features a partial cup shape, multiple screw holes and three flanges. The reconstruction ring is secured to host bone or graft bone with bone screws. A Reflection All Poly Cup may be cemented in the reconstruction ring with polymethylmethacrylate (PMMA) bone cement.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document describes a 510(k) premarket notification for a medical device called the "Contour HA Coated Reconstruction Ring". It primarily focuses on:

• Intended Use: What the device is designed for (total hip components and acetabular reinforcement/reconstruction rings).
• Device Description: A brief physical description of the ring.
• Substantial Equivalence: The core of a 510(k) submission, where the manufacturer claims the new device is as safe and effective as existing legally marketed devices (predicates). This is evidenced by comparing materials, indications for use, and design.

The FDA's response confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. However, this type of submission usually relies on demonstrating equivalence through design and material comparisons, rather than extensive clinical performance studies with specific statistical acceptance criteria that would typically be described for a new, novel device or for performance claims.

Therefore, I cannot provide the requested information.

Ask a specific question about this device