(75 days)
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- · Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).
- RESTORIS™ MCK Uni: .
- Unicompartmental femoral condyle components o
- Unicompartmental tibial onlay components (tibial baseplate and tibial onlay o insert)
- Unicompartmental tibial inlay components 0
- RESTORIS™ MCK PF: .
- Patellofemoral trochlear components o
- Patella components o
The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multi-compartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.
The provided document, a 510(k) summary for the RESTORIS™ Multicompartmental Knee (MCK) System, describes the device and its intended use, but it does not contain information related to acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document states that the device has been evaluated through "non-clinical performance testing" for various aspects, and concludes that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." However, it does not specify what these performance criteria were, what the acceptance thresholds for these criteria were, or the detailed results demonstrating that these criteria were met.
Therefore, I cannot populate the table or answer the specific questions posed, as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices rather than presenting detailed clinical or performance study results against predefined acceptance criteria.
Key takeaway: This document does not pertain to an AI/ML powered device, so acceptance criteria and study design as outlined in the prompt are not applicable to the information provided.
§ 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.