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The MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

• · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic 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.
• · Revision of previous unsuccessful knee replacement or other procedure
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques

Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• · Absent or nonfunctioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint

The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. This submission is to add a cruciate retaining (CR) device type to the system, including the CR femoral component and corresponding CR Tibial inserts. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.

The MOBIO Total Knee System includes left and right femoral components for the Cruciate Retaining (CR) system. These components are manufactured from cast cobalt chrome conforming to ASTM F75. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Fixed femoral pegs on the femoral components provide additional medio-lateral fixation.

The CR Tibial Inserts are offered in a total of 50 sizes, size A/1-4 through HJ/7-10, with 10 thicknesses ranging from 9 to 25mm (total thickness with Tibial Baseplate is 9 to 25mm). The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

All system components are supplied sterile and are single use devices.

The provided text is a 510(k) premarket notification for the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria or reporting on the performance of an AI/ML powered medical device.

Therefore, the information required to answer your questions about acceptance criteria for an AI/ML device and its study is not present in the provided text. The document describes a traditional medical device (knee replacement system) and addresses its physical properties, materials, manufacturing, and intended use, comparing them to existing devices.

The "Performance Data" section in the document refers to non-clinical studies for the physical knee replacement components (e.g., locking mechanism strength, contact stress, range of motion, material characterization, biocompatibility, shelf life, bacterial endotoxin testing). These are for the mechanical device itself, not for an AI/ML algorithm's performance.

To answer your request, I would need a document detailing the performance evaluation of an AI/ML medical device, which would typically involve clinical validation studies, metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.

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