(151 days)
The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to:
- . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
- Failed osteotomies, failed partial knee replacement, or failed prior total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
- . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities. .
Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.
The Pipeline Primary CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation.
The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
The provided text is a 510(k) Summary for the Pipeline Primary CR Knee System, which is a medical device (total knee system). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are not typically required or described in a 510(k) summary for this type of device.
510(k) summaries, like this one, primarily focus on demonstrating substantial equivalence to legally marketed predicate devices. This involves comparing the new device's indications for use and technological characteristics (e.g., materials, design features) to those of the predicate devices. Performance testing mentioned in such summaries is usually related to ensuring the device is capable of withstanding anticipated physiological conditions, rather than a clinical study with specific performance metrics against acceptance criteria that would include human-AI interaction or expert review.
Therefore, I cannot fulfill the request to provide acceptance criteria and a study proving the device meets them based solely on the provided input. The prompt's requirements (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) are typical for AI/ML-driven medical device submissions and are not applicable to the Pipeline Primary CR Knee System, which is a physical implant.
In summary, the provided document does not contain the information required to answer the prompt.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.