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EXPRT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

The provided document is a 510(k) premarket notification for a medical device called the EXPRT™ Revision Hip System. This type of notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not include extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application or a more comprehensive clinical trial report for AI/software devices.

Instead, the document focuses on demonstrating substantial equivalence based on indications for use, material, design features, dimensions, surgical implantation technique, intended use, packaging, sterilization, and non-clinical testing.

Therefore, many of the requested items regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or not provided in this specific FDA 510(k) document.

However, I can extract the information that is present:

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

The document does not provide a table with specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics often associated with AI/diagnostic devices. Instead, the "performance" here refers to the device's ability to meet non-clinical testing standards and be substantially equivalent to predicates.

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

This information is not provided as a formal clinical test set with specific sample sizes. The "testing" mentioned refers to non-clinical fatigue and endotoxin testing, not a clinical study on human subjects with a test set.

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 information is not applicable as there was no clinical study or test set requiring expert-established ground truth for performance evaluation of a diagnostic or AI algorithm.

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

This information is not applicable as there was no clinical study or test set requiring 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

An MRMC study is not applicable as this is a physical medical device (hip replacement system), not an AI or diagnostic software.

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

This is not applicable as this is a physical medical device.

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

This is not applicable for the purpose of this 510(k). The "ground truth" for the device's safety and effectiveness is largely based on its similarity to legally marketed predicate devices and its ability to pass non-clinical engineering and material tests.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This is not applicable as this is a physical medical device.

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Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

This document is a 510(k) summary for the EXPRT™ Revision Hip System, a medical device. It does not describe an AI/ML medical device, and therefore the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, is not present.

The document is a regulatory submission for a traditional medical device (a hip replacement system). The "acceptance criteria" and "study" mentioned here refer to the non-clinical and pre-clinical testing required for substantial equivalence, not performance metrics for an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical hip implant (EXPRT™ Revision Hip System). There is no mention of any AI or machine learning component.
• "Acceptance Criteria" Context: For a physical device like a hip implant, "acceptance criteria" typically relate to mechanical strength, biocompatibility, material properties, and manufacturing quality, not diagnostic performance or AI model accuracy.
• "Study" Context: The document mentions "Non-Clinical Testing: ROM testing and distal fatigue testing," and "Endotoxin Assessment," which are standard tests for orthopedic implants to determine their mechanical integrity and safety. It explicitly states, "Clinical Testing: Clinical testing was not required." This indicates that the substantial equivalence was based on non-clinical data comparing it to existing predicate devices.

Therefore, it is impossible to provide the requested information in the format specified because it pertains to an AI/ML context that is not applicable to this document.

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