(31 days)
Not Found
Not Found
No
The device description and intended use focus on a physical implant (acetabular cup) made of polyethylene with a wire marker for X-ray location. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is an acetabular component used in hip replacement surgery to rehabilitate hips damaged by various degenerative joint diseases and trauma, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a medical implant (acetabular component) used in hip replacement surgeries, not a tool for diagnosing medical conditions.
No
The device description clearly states it is an "all-polyethylene acetabular component," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Opera Cup is a physical implantable device (an acetabular component for hip surgery). It is made of polyethylene and is designed to be surgically placed in the body.
- Intended Use: The intended use describes the surgical implantation of the device to treat damaged hips. It does not involve testing samples outside the body.
- Input Imaging Modality: While X-ray is mentioned, it's used for post-operative assessment of the implanted device, not for diagnostic testing of a sample.
Therefore, the Opera Cup is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenitaldysplasia; old, remote osteomyelitis with an extended drainage-free 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.
Product codes
87JDI, LZO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Spectron All-Polyethylene Acetabular Component, Depuy OGEE® Flanged Acetabular Cup, Depuy All-Polyethylene Cemented Acetabular Cup
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary OPERA CUP
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAC NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Biollefi
(Division Sign-Off) Division of General Restorative Devices K9915 510(k) Nümber -
Prescription Use X
(Per 21 CFR 801.109)
ાર
Over-The-Counter Use_
(Optional Format