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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 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, 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 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 purpose of this 510(k) application is to extend the compatibility of the subject devices between Signature Orthopaedics and Encore Medical components. The subject devices themselves have not undergone any changes.

The provided document is a 510(k) premarket notification for hip replacement prostheses. It details the device name, regulation, and a claim of substantial equivalence to previously marketed predicate devices. However, it does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical performance sections of submissions for new or significantly modified devices.

Instead, this document focuses on extending the compatibility of existing subject devices with other components. The core argument for substantial equivalence is that the devices themselves have not undergone any changes, only their compatibility with other components has been extended. Therefore, the "performance testing" described refers to engineering evaluations to ensure that the performance remains equivalent to predicate devices when used in these new combinations.

As such, many of the requested items related to acceptance criteria, clinical studies, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not present or not applicable in this specific FDA clearance document, as it's not a de novo clearance or a submission for a novel AI/software as a medical device (SaMD).

Here's an analysis based on the information provided, with an emphasis on what is not present given the nature of the document:

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

No explicit "acceptance criteria" table for a clinical performance study is provided. The document states that "engineering evaluations concluded that the performance of the subject devices will remain at least equivalent to the predicate devices when used in combinations as per the expanded compatibility." The performance testing listed appears to be bench testing rather than clinical study.

Performance Testing (Engineering Evaluations/Bench Testing):

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

Not applicable for a clinical study. The testing described appears to be bench/laboratory testing of the physical hip prostheses components. The document does not specify sample sizes for these engineering evaluations, nor does it refer to patient data (e.g., country of origin, retrospective/prospective).

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

Not applicable. There is no mention of experts establishing a ground truth for a test set, as this is not a clinical or AI/SaMD performance study.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as there is no test set in the context of a clinical performance study.

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. This document does not pertain to an AI/SaMD device, and therefore no MRMC study or AI assistance evaluation was conducted.

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

No. This document does not pertain to an AI/SaMD device, and therefore no standalone algorithm performance study was conducted.

7. The type of ground truth used

Not applicable in the context of clinical "ground truth." The "ground truth" for these engineering evaluations would be the established performance characteristics and safety criteria defined by the relevant ISO and ASTM standards (e.g., specific fatigue limits, wear rates, pull-out forces), against which the tested devices' physical properties are measured.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/SaMD device.

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

Not applicable. There is no mention of a training set.

In summary: This FDA 510(k) clearance document for hip replacement prostheses makes a claim of substantial equivalence based on the fact that the actual devices have not changed, only their compatibility with other components has been extended. The "performance testing" referenced is a series of engineering/bench tests against international standards (ISO and ASTM) to ensure that the performance of the components remains equivalent to predicate devices in these extended combinations. It is not a clinical study involving patients, human readers, or AI/software performance.

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