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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 and Spartan 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 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

Signature Orthopaedics' Spartan Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Spartan Stem has a triple tapered geometry and features a titanium and hydroxyapatite plasma spray proximal coating below its resection line for cementless fixation in total hip arthroplasty.

This document is a 510(k) premarket notification from Signature Orthopaedics Pty Ltd. for their Spartan Hip Stem. It establishes substantial equivalence to predicate devices based on indications for use, material, design, and non-clinical performance testing.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

Critical Observation: The provided document is for a medical device (hip stem prosthesis), not a software or AI-based diagnostic device. Therefore, the questions regarding AI/software performance metrics like "acceptance criteria table with device performance," "sample size for test set," "ground truth establishment," "MRMC study," and "standalone algorithm performance" are not applicable in the context of this device.

The acceptance criteria and performance evaluation for a hip stem prosthesis primarily revolve around mechanical properties, biocompatibility, and intended use, verified through non-clinical (and sometimes clinical) testing as described below.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, acceptance criteria relate to its physical and functional performance, materials, and design, rather than diagnostic accuracy.

2. Sample Size Used for the Test Set and Data Provenance

Since this is a mechanical device, not a software intended for diagnostic interpretation:

• Test Set Sample Size: Not in terms of 'cases' or 'patient data'. Instead, the "sample size" would refer to the number of physical device units tested for each mechanical test (e.g., how many stems for fatigue testing). This specific number is not explicitly stated in the provided document, but it's understood to be sufficient to demonstrate statistical validity for the type of engineering tests conducted.
• Data Provenance: The tests are "non-clinical testing and engineering evaluations" conducted by the manufacturer, Signature Orthopaedics Pty Ltd., which is based in Australia. The data is derived from laboratory-based, prospective mechanical and material testing of the device prototypes. No patient or human data is involved.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable for a hip stem prosthesis. "Ground truth" in this context is established by engineering standards and validated material properties, not by expert medical interpretation of images or patient data. The experts involved would be engineers, material scientists, and quality control specialists performing the tests and comparing results against established ISO/ASTM standards. Their qualifications would be in biomechanics, materials science, and mechanical engineering.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication (e.g., 2+1, 3+1 for clinical consensus) is used for clinical data interpretation or image reading tasks. For engineering test results, the "adjudication" is against pre-defined engineering pass/fail criteria and adherence to relevant industry standards (e.g., ISO, ASTM). Test results either meet the specification or they don't; there isn't a subjective "adjudication" process as there would be for clinical endpoint determination or image truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI or new imaging techniques on human reader performance for diagnostic tasks. Since the Spartan Hip Stem is a physical implant, not a diagnostic tool, such a study would be irrelevant. The substantial equivalence claim is based on engineering principles and performance comparable to existing cleared devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study was not done. This term applies to the performance of an AI/algorithm without human intervention in a diagnostic workflow. It's irrelevant to a hip stem. The "standalone performance" of the hip stem is its mechanical performance and safety, which was evaluated through the non-clinical tests listed.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is:

• Engineering Standards and Specifications: Adherence to established international and national standards for orthopedic implants (e.g., ISO 21535, ISO 5832-3, ASTM F136).
• Material Properties: Verified material characteristics (e.g., Ti6Al4V composition, non-pyrogenicity).
• Predicate Device Performance: The "ground truth" for substantial equivalence is that the new device performs similarly and is as safe and effective as the legally marketed predicate devices, as demonstrated by meeting comparable engineering performance metrics.

8. Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning models. A hip stem device does not have a "training set" in this sense. Its design and manufacturing processes are based on established engineering principles, material science, and experience with previous hip implant designs and their long-term clinical outcomes (which inform the design specifications, but not through a machine learning "training" process).

9. How the Ground Truth for the Training Set was Established

As "training set" is not applicable, the establishment of "ground truth" for a non-existent training set is also not applicable. The underlying engineering knowledge and design parameters that guide the creation of such a device are based on decades of biomechanical research, clinical data from existing implants, and material science, all contributing to the design and testing specifications used.

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