(31 days)
The Opera Cup is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) of any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
It is also indicated for 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 drainagefree period, in which case, the patient should be warned of an above normal danger of infection postoperatively: 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 fracture-dislocation of the hip; and correction of deformity.
The Opera Cup all-polyethylene acetabular component is a hemispherical cup with a non-concentric flange protruding from its rim. The component is made from Ultra-High-Molecular-Weight Polyethylene (ASTM F-648). The outer surface of the hemisphere has concentric grooves around the periphery. A wire marker is located in the one of the grooves for implant location on X-ray. The flange is designed to be trimmed to conform with the anatomy of the individual patient to allow closure at the acetabular rim; thus ensuring good cement containment and pressurization.
The provided text is a 510(k) summary for the Opera Cup, an all-polyethylene acetabular component. This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria through a clinical study with performance metrics.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for a performance study cannot be extracted from this document.
The 510(k) process for devices like the Opera Cup typically relies on:
- Bench testing: To demonstrate material properties, mechanical strength, and other physical characteristics are comparable to predicate devices.
- Material compatibility: Confirmation that the Ultra-High-Molecular-Weight Polyethylene (UHMWPE) meets established ASTM standards (ASTM F-648).
- Design comparison: Showing the design features (hemispherical cup, non-concentric flange, wire marker, grooves) are similar in function and performance to predicate devices.
- Intended Use comparison: Demonstrating that the indications for use are substantially similar to legally marketed devices.
The text states: "The Opera Cup is similar to the legally marketed devices listed above in that these devices are indicated for total hip replacement, are manufactured from similar or like materials, and are similar in technological characteristics." This statement encapsulates the basis for its 510(k) clearance, which is substantial equivalence, not a direct clinical performance study against pre-defined acceptance criteria as one might see for an AI/CADe device or novel therapeutic.
In summary, the provided document does not contain the information required to populate the table or answer the questions related to acceptance criteria and a study proving the device meets those criteria, as it's a submission for a medical device seeking clearance based on substantial equivalence.
§ 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.