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The Klassic 110 BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:

• o Femoral neck and trochanteric fractures of the proximal femur
• Osteonecrosis of the femoral head
• Revision procedures where other devices or treatments for these indications have failed.

The Klassic™ BiPolar System includes the Klassic™ BiPolar System BiPolar Head, Klassic 110 BiPolar System Femoral Head (12-14 Taper), 22mm, and Klassic 100 BiPolar System Femoral Head(12-14 Taper), 28mm implant components ("Klassic"") BiPolar System Implants").

The Klassic"10 BiPolar System BiPolar Head includes a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner, cobalt chrome outer shell, and a UHMWPE retention ring with a Ti6A14V spring. The Bipolar Head includes an outer diameter range from 38 to 43 mm with an inner diameter which mates with the 22 mm femoral head, and an outer diameter range from 44 to 60 mm with an inner diameter which mates with the 28mm femoral head. The Bipolar Heads are offered in 1 mm outer diameter size increments.

The Klassic™ BiPolar System Femoral Heads include a 12/14 Taper for interfacing with TJO's Klassic HD10 Femoral Stems (K100445), and TJO's Klassic HD™ Offset Femoral Stems (K133832). These heads available with offsets of Neutral, +3.5mm and +7.0mm for the 22mm Femoral Head, and -3.5, Neutral, +3.5mm and +7.0mm for the 28mm Femoral Head.

This document does not describe a study involving an algorithm or AI. It is a 510(k) premarket notification for a medical device called the "Klassic™ BiPolar System," a hip joint femoral prosthesis. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and non-clinical testing.

Therefore, I cannot provide the requested information about acceptance criteria for an algorithm, study design for AI performance, sample sizes for AI development/testing, expert adjudication, MRMC studies, or standalone algorithm performance.

The document does mention "Non Clinical Testing, including fatigue, disassembly and range of motion," which was completed to demonstrate that the Klassic™ BiPolar System did not create a new worst case. However, this refers to mechanical device testing, not AI performance.

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