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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint 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, World and Encore 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

Signature Orthopaedics' Encore Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Encore Stem is straight and tapered with a rectangular cross-section. The stem has a polished distal tip to reduce fixation leading to proximal stress shielding. It features a titanium and hydroxyapatite plasma spray proximal coating below its resection line.

The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Encore Hip Stem." It concerns the regulatory approval process for a new hip implant. The document does not contain information about software or AI-based devices; therefore, it does not include acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set information as requested in the prompt.

The document discusses the substantial equivalence of the Encore Hip Stem to previously cleared predicate devices based on non-clinical performance testing and engineering evaluations. These tests are related to the mechanical properties and design of the physical implant, not the performance of an AI algorithm.

Specifically, the "Performance Testing" section states:
"Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Encore Hip Stem is adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:

• Range of Motion Testing
• Stem and Neck Fatigue FEA
• Stem and Neck Fatigue Testing
• Rim Impingement Analysis"

Therefore, I cannot provide the requested information from the given text as it pertains to a physical medical device, not an AI or software device.

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Total and partial hip replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint diseasc including osteoarthritis and avascular necrosis of the . natural femoral head;
• . rheumatoid arthritis;
• . correction of functional deformity;
• femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts.

The Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.

The modification consists of use of a ceramic femoral head with the hip stem. The material used in the ceramic femoral head is the same as other legally marketed predicate devices.

. ne Vitality, Keystone, Alfa II, R120 and R120PC are all designed for total hip joint replacement.

The provided document is a 510(k) premarket notification for a medical device manufacturer seeking clearance to market a modified hip stem product. It describes the device, its intended use, predicate devices, and the FDA's clearance letter. However, this document does not contain information related to acceptance criteria, device performance metrics, or a study proving that a device meets such criteria as would be expected for an AI/ML-based medical device.

The product in question is a ceramic femoral head used in conjunction with existing hip stems (Vitality, Keystone, Alfa II, R120, R120PC). The clearance is based on substantial equivalence to predicate devices, and the manufacturer explicitly states "Clinical Testing: None provided." The type of testing performed was "Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions."

Therefore, I cannot provide the requested information. The document focuses on mechanical properties and material compatibility, not on the performance metrics of an AI/ML system.

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