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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 and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only.

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' SS Cemented TSI Hip Stems are manufactured from High Nitrogen Stainless Steel per ASTM-F1568 and ISO 5832-9. The SS Cemented TSI stem is a highly polished anatomically curved stem with a round cross-section intended for cemented use in total hip arthroplasty. The Cemented TSI Hip Stems are compatible with Signature Orthopaedics' Ceramic Femoral Heads (per K121297).

This document describes the FDA's clearance of the Signature Orthopaedics Cemented TSI Hip Stem (K192024). However, the provided text does not contain details about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML-enabled medical device.

The document primarily focuses on the regulatory clearance process for a traditional medical device (a hip stem), establishing its substantial equivalence to previously cleared predicate devices. The "Performance Testing" section mentions:

• Stem fatigue and neck fatigue testing per ISO 7206-4 and ISO 7206-6.
• Engineering evaluations to verify performance is equal to or better than the predicate device.
• Validation as non-pyrogenic.

These are standard mechanical and biocompatibility tests for orthopedic implants, not performance studies for AI/ML algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving an AI device meets them based on the provided text. The document does not describe an AI/ML-enabled device or its associated performance studies.

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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 and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve and Cemented TSI femoral stems are intended for cemented fixation only.
  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 hemihip 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 TSI Hip Stems are manufactured from Forged CoCr per ASTM-F799. The Cemented TSI stem is a highly polished anatomically curved stem with a round cross-section intended for cemented use in total hip arthroplasty.

This document is a 510(k) premarket notification for a medical device (Cemented TSI Hip Stem). It focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical performance testing for a new type of device.

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets, expert ground truth establishment, or multi-reader studies is not applicable to this type of regulatory filing.

This document describes a conventional medical device (a hip stem), not an AI or algorithm-driven device. The "acceptance criteria" here relate to manufacturing, material properties, and mechanical performance, not diagnostic accuracy or AI model performance.

Here's how to address the prompt given the nature of the document:

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

The "acceptance criteria" for this device are established through performance testing and engineering evaluations to show that the device is suitable for its intended use and substantially equivalent to predicate devices. These are not performance metrics like sensitivity/specificity, but rather material and mechanical properties.

2. Sample sized used for the test set and the data provenance

• Sample Size: The document mentions "worst case sizes of the stems" were tested for performance (fatigue, head tests). It does not specify a numerical sample size (e.g., N=x units tested) for these mechanical tests.
• Data Provenance: Not explicitly stated as "retrospective" or "prospective" as these terms usually apply to clinical or algorithm studies. The testing is non-clinical (benchtop) and conducted by the manufacturer, Signature Orthopaedics Pty Ltd, located in Lane Cove, NSW, Australia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a mechanical device, not an AI diagnostic algorithm. "Ground truth" in this context refers to established material properties and mechanical performance standards, verified through engineering tests, not human expert interpretation of images or clinical data.

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

• Not Applicable. This concept applies to expert consensus in clinical data labeling for AI training/testing, which is not relevant for this mechanical device.

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

• Not Applicable. No MRMC study was done, as this is not an AI/imaging device designed to assist human readers.

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

• Not Applicable. No standalone algorithm performance was assessed as there is no algorithm under review.

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

• Implicit Ground Truth: For this device, the "ground truth" is defined by established engineering standards, material specifications (e.g., ASTM-F799), and biomechanical principles that dictate the functional requirements and safety of a hip implant. Performance is evaluated against these predefined, objective engineering benchmarks, not subjective human interpretation or clinical outcomes data in a study context (though long-term clinical performance is a general goal of such devices once marketed).

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI model, this question is irrelevant to the device described.

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