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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks.
   EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.

The EMPHASYS Dual Mobility System includes Co-Cr-Mo Dual Mobility Liners and AOX Polyethylene Mobile Bearing Heads as well as other previously cleared compatible components.

This is a 510(k) summary for a medical device called the EMPHASYS™ Dual Mobility System, specifically for hip replacement. The document does not describe a study involving an algorithm or AI, but rather a series of physical performance tests conducted on the device itself to demonstrate its substantial equivalence to existing predicate devices.

Therefore, many of the requested categories related to AI model evaluation, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable to this type of device clearance submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table alongside reported performance results in an easy-to-digest format. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria are that the device performs "as well as" or equivalently to the predicate devices under these tests.

No direct table of acceptance criteria vs. reported performance is provided in the document. The document states: "Results of performance testing and analyses demonstrate that the EMPHASYS Dual Mobility System performs as well as the predicate devices."

The tests conducted are:

• EMPHASYS Mobile Bearing Head Thickness Assessment
• EMPHASYS Dual Mobility Liner Thickness Assessment
• Range of Motion Analysis- ISO 21535:2007
• EMPHASYS Mobile Bearing Head Impingement-ASTM F2582-20
• EMPHASYS Dual Mobility Impingement Testing to ASTM F2582-20
• EMPHASYS Dual Mobility Liner Push-Out- ASTM F1820-22
• EMPHASYS Dual Mobility Liner Offset Pull-Out- ASTM F1820-22
• EMPHASYS Dual Mobility Liner Torque-Out- ASTM F1820-22
• EMPHASYS Mobile Bearing Head Lever-Out
• EMPHASYS Dual Mobility ASTM F1875 Method I Test
• EMPHASYS Dual Mobility Non-Aged Standard Walking Wear Test- ISO 14242-1:2014 and ISO 14242-2:2016.
• EMPHASYS Dual Mobility Standard Walking with Mode 3 Third Body Abrasive Wear Test - ISO 14242-1:2014, ISO 14242-1 AMD 1:2018, ISO 14242-2:2016 and ISO 14242-4:2018.
• EMPHASYS Dual Mobility High Angle Standard Walking Wear Test- ISO 14242-1:2014, ISO 14242-2:2016 and ISO 14242-4:2018.
• EMPHASYS Dual Mobility Worst Case Outer Bearing Wear of EMSYS DM under Standard Walking Wear- ISO 14242-1:2014 and ISO 14242-2:2016
• EMPHASYS Dual Mobility Friction Test- ASTM F3143-20
• MRI Safety Evaluation Testing of Total Hip Systems- ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21, ASTM F2213-17, and ASTM F2119-07

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

Not applicable. This pertains to physical device testing rather than a software or AI evaluation with patient data. The "test set" would be the physical devices and components manufactured for testing. The document does not specify the number of individual devices or components tested for each category.

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

Not applicable. The "ground truth" for these physical tests is established by recognized engineering standards (e.g., ISO, ASTM) and comparative performance against predicate devices, not by expert medical interpretation of data.

4. Adjudication method for the test set

Not applicable. This applies to medical imaging or diagnostic studies, not physical device performance testing against engineering standards.

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. This is a hardware device (hip prosthesis) clearance, not an AI software clearance.

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

Not applicable. This is a hardware device clearance.

7. The type of ground truth used

The "ground truth" in this context refers to the established performance requirements and benchmarks defined by international and national engineering standards (ISO and ASTM) and the performance characteristics of previously cleared predicate devices. The device must demonstrate that its performance meets these standards and is equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is a hardware device clearance, not an AI software clearance.

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

Not applicable. This is a hardware device clearance, not an AI software clearance.

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