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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.

The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) clearance letter for the CATALYSTEM Femoral Stems. It primarily addresses the regulatory approval process rather than detailing a study proving the device meets specific acceptance criteria in the context of an AI/software device.

The provided text does not contain information related to AI/software device performance or studies proving such a device meets acceptance criteria. It describes a medical device (femoral stems for hip replacement) and its regulatory clearance based on substantial equivalence to a predicate device.

Specifically, it states:

• "No clinical tests were performed to support safety and efficacy of the subject device."
• Bench testing was performed for mechanical properties (e.g., fatigue, range of motion, impingement), which are relevant to orthopedic implants, not AI performance.
• The clearance is a "Special 510(k)" primarily for "additional femoral head compatibility."

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets them from this document. The concepts of ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and test sets are not applicable to the information provided in this 510(k) clearance letter for a mechanical implant.

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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Traditional 510(k) is to notify the FDA of our intent to market the Smith & Nephew CATALYSTEM Femoral Stems. The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary hip arthroplasty in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options. The CATALYSTEM Femoral Stems are non-cemented femoral hip stems manufactured from forged titanium alloy and feature a CP-Ti and HA coating.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) summary for the CATALYSTEM Femoral Stems. It describes a medical device, specifically hip joint components, and outlines the testing and analyses conducted to demonstrate its substantial equivalence to previously marketed devices. This type of submission does not typically involve AI/ML components or studies on diagnostic performance, but rather focuses on mechanical integrity, materials, and biocompatibility.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable in the context of this device and submission type. The device is a physical implant, not a diagnostic software or AI product.

However, I can provide the acceptance criteria and a summary of the studies that prove the device meets these criteria based on the non-clinical testing performed, as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each mechanical or material test. These tests typically involve a defined number of samples according to the specific ASTM or ISO standard being followed. Data provenance is implied to be from Smith & Nephew's internal testing labs or contracted testing facilities, as these are non-clinical (laboratory) studies. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

This is not applicable. For mechanical and material testing of implants, "ground truth" is established by the specifications defined in recognized national and international standards (e.g., ISO, ASTM). The "experts" are the engineers and material scientists conducting and interpreting these standardized tests, whose qualifications are inherent in their ability to perform such tests according to regulatory requirements. No clinical expert consensus is involved in establishing the "truth" for these non-clinical tests.

4. Adjudication method for the test set

Not applicable. Mechanical and material tests follow defined methodologies in their respective standards. The results are quantitative and directly measured against pre-defined acceptance criteria, not subject to subjective adjudication.

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, as this is not an AI/ML-driven diagnostic device.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is based on:

• Engineering specifications and design requirements: Derived from the predicate devices and industry best practices.
• Recognized national and international standards: Such as ISO (e.g., ISO 7206, ISO 21535, ISO 10993, ISO 13779) and ASTM (e.g., ASTM F2996, ASTM F1147, ASTM F1044, ASTM F1160, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119). These standards define acceptable performance metrics for medical devices of this type.

8. The sample size for the training set

Not applicable, as this is not an AI/ML-driven diagnostic device.

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

Not applicable, as this is not an AI/ML-driven diagnostic device.

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