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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, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only.

Signature Orthopaedics' BiPolar Head is intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The BiPolar Head is 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 Remedy™ and Pegasus™ hip stems are intended for cementless use in total hip arthroplasty. The Evolve™ hip stem is intended for cemented total hip arthroplasty. The Remedy™, Pegasus™ and Evolve™ hip stems connect to a femoral head (cobalt-chrome alloy or ceramic) via 12/14 taper connection.

The Remedy™ Hip Stem has a tapered wedge geometry. The stem is manufactured from titanium alloy per ASTM F136. The proximal stem is porous coated with titanium beads and particles per ASTM F67 and the distal stem is matte finished.

The Pegasus™ is a double tapered, straight stem with rectangular cross-section. The stem has a lateral wing for engaging the greater trochanter. The stem is manufactured from titanium alloy per ASTM F136. The stem is grit blasted below the resection line.

The Evolve™ Hip Stem is a highly polished, tapered wedge stem with a rounded crosssection. The Evolve™ Hip Stem is manufactured from high nitrogen stainless steel per ISO 5832-9. The Evolve™ Hip Stem is available in two variants, the Masters series and the Helios Series. Both variants share similar general geometry but are sized differently to provide a more complete range. The Evolve™ Hip Stem includes two accessories, the Evolve™ Distal Centralizer and Evolve™ Cement Plug. The Evolve™ Distal Centralizer is a PMMA cap that sits on the end of the Evolve™ Hip Stem and centralizes it within the femoral canal. The Evolve™ Cement Plug is manufactured from polyethylene per ASTM F648 and is pressed into the femoral canal prior to inserting the Evolve™ Hip Stem to allow cement pressurization.

The BiPolar Head consists of a stainless steel outer shell (per ISO5832-9) and a UHMWPE insert (per ASTM F648). The outer shell is highly polished to articulate against the patient's natural acetabulum. The insert articulates against a Signature Orthopaedics 28mm cobalt-chrome femoral head (K121297). The 28mm femoral head connects to a femoral stem from Signature Orthopaedics' range to complete the hip hemiarthroplasty.

The provided text describes a 510(k) premarket notification for various hip implants (Remedy™, Pegasus™ and Evolve™ Hip Stems and BiPolar Head) and details the non-clinical performance testing conducted to support their substantial equivalence claim to predicate devices. It does not present acceptance criteria in a quantitative format, nor does it detail a clinical study with a control group or human readers.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it lists general performance tests conducted and then concludes that "Non-clinical testing results support the substantial equivalence claim. The RemedyTM, Pegasus™ and Evolve™ Hip Stems and BiPolar Head are expected to perform adequately during clinical use."

The performance tests conducted include:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical testing and engineering evaluations." This implies in-vitro or bench testing, not patient data. Therefore, concepts like sample size, country of origin, or retrospective/prospective for a patient-based test set are not applicable here. The "test set" would consist of the orthopedic implants subjected to the various physical and mechanical tests. The sample sizes for each specific test are not reported. The company is Australia-based (Signature Orthopaedics Pty Ltd, Lane Cove, NSW 2066, Australia).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The device is a physical hip implant. "Ground truth" in this context would refer to the physical and mechanical properties of the device as measured by engineering standards, not expert interpretations of medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the evaluation involves non-clinical engineering tests, not human interpretation or adjudication of medical data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. The document describes hip implants, which are surgical devices, and the testing performed is non-clinical engineering evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This question is also relevant for AI/software as a medical device (SaMD) and does not apply to physical hip implants.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for the non-clinical testing refers to established engineering standards, material properties, and biomechanical principles. For example, fatigue testing would compare the device's performance against known limits for medical implants, and material characterization would be compared against ASTM or ISO standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in this context would imply the manufacturing and design process of the device itself and the various components.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8. The "ground truth" for the design and manufacturing of the implants would be established through engineering specifications, material selection criteria based on ISO/ASTM standards, and biomechanical research for hip implant design.

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