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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip ioint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment. the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular ● necrosis
• . Inflammatory joint disease including rheumatoid arthritis
• . Correction of functional deformity including congenital hip dysplasia
• . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan and World Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture .
• . Fracture dislocation of the hip
• . Avascular necrosis of the femoral head
• . Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• . Degenerative arthritis involving only the femoral head

The Signature Orthopaedics' Cemented Origin Hip Stems are manufactured from High Nitrogen Stainless Steel per ASTM-F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin stem is a highly polished and is intended for cemented use in total hip arthroplasty. The Cemented Origin Hip Stems are compatible with Signature Orthopaedics' Ceramic Femoral Heads (per K121297).

The provided text describes the 510(k) premarket notification for the "Cemented Origin Hip Stem". The information focuses on the device's substantial equivalence to predicate devices, its indications for use, and the performance testing conducted. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device submission.

Specifically, the document includes:

• General FDA clearance information for a medical device (hip stem).
• Details about the device's material, design, and manufacturing.
• Indications for Use.
• A list of non-clinical, mechanical performance tests (Stem fatigue testing per ISO 7206-04, Neck fatigue testing per ISO 7206-6). These are standard tests for orthopedic implants to ensure mechanical integrity.
• A statement of "Substantial Equivalence" to predicate devices based on intended use, indications for use, design features, and non-clinical testing results.

The questions you've asked (about acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training data, etc.) are highly relevant to the evaluation of AI/ML-driven medical devices. This document, however, describes a traditional orthopedic implant, not an AI/ML device. Therefore, the requested information points (1-9) cannot be extracted from the provided text as they pertain to a different type of medical device evaluation.

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