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The Orthopedic Source Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because of: degenerative joint disease, including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended for cementless use.

Indications for Use:

• 1. noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity;
• 4. revision procedures where other treatments or devices have failed; and,
• 5. treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This implant is intended for cementless use.

The Orthopedic Source stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. It is a collarless flat wedge-shaped implant that provides excellent durability and stability in a design that is relatively simple and predictable to implant. The use of a collarless designity the Orthopedic Source hip tends to allow for self seating of the implant and achievement of optimal rotational stability, immediately after implantation. The incorporation of standard and lateralized offset options provides the surgeon the ability to reconstruct a stable joint with proper leg length in virtually all patient anatomies. The Orthopedic Source Stem has a 135° rack shaft angle and a standard 12/14 Morse type taper is incorporated in to the geometry to receive modular heads. The proximal body is circumferentially coated with commercially pure titanium plasma spray. Femoral heads are manufactured from wrought CoCrMo alloy conforming to ASTM F799 and are available in 22m, 28mm and 32mm diameters and multiple neck lengths.

This document is a 510(k) summary for a premarket notification for a hip implant, specifically the Orthopedic Source Press-fit Hip. This is a medical device approval for a physical product and not a software device, therefore, the requested information about acceptance criteria and studies (test set, ground truth, expert involvement, etc.) is not applicable in the context of AI/software performance.

The document describes the device, its intended use, and compares its technological characteristics to a predicate device (Taperloc Hip). The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device that was on the market prior to May 28, 1976, or has been reclassified.

The "testing" mentioned in this document is in the context of mechanical engineering analysis for the hip implant's strength and durability, not for a software algorithm's performance.

Therefore, I cannot populate the table or provide details on the study types (MRMC, standalone), sample sizes for test/training sets, or methods for establishing ground truth, as these concepts are relevant to software/AI device evaluation and not to the mechanical device described in this 510(k) summary.

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