(79 days)
LOSPA II Knee System (EXULT Knee Replacement System) is indicated for the treatment of diseases as follows:
· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
· Post-traumatic loss of knee joint configuration and function;
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
· Correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
LOSPA II Knee System (EXULT Knee Replacement System) is intended for cemented application only.
The Additional components being added to the LOSPA II Knee Replacement System (EXULT Knee Replacement System) are:
- Revised Size 12 PS, CR Femoral Component -
- Additional Size 13 PS, CR Femoral Component -
- -Instrumentation
The subject LOSPA II Knee System (EXULT Knee Replacement System) components specification inclusions are a line extension of Femoral Components and Instrumentation system.
The provided text does not describe an AI/ML powered device, nor does it detail any clinical studies involving such technology.
The document is a 510(k) clearance letter from the FDA for a LOSPA II Knee System (EXULT Knee Replacement System), which is a traditional medical device (a knee replacement prosthesis). The clearance is for additional components to an already cleared system.
Therefore, I cannot provide answers to the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device, as this information is not present in the provided text.
The "PERFORMANCE TESTING - BENCH" section refers to mechanical testing of the knee replacement components against established ASTM and ISO standards, not clinical studies for an AI/ML algorithm.
§ 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.