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The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.

The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).

The provided text is a 510(k) Summary for the Trident® Tritanium® PST® Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/software device would.

This document describes a medical device (an acetabular shell for hip replacement), not a software or AI product. The "Performance Testing" section refers to comparisons of materials, manufacturing methods, design features, and disassembly testing per ASTM F1820 (including push-out, and torsional testing) to demonstrate substantial equivalence to predicate devices.

Therefore, most of the requested information (related to AI performance, sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission for a physical medical device.

I can only extract the following relevant information:

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

Based on the document, specific acceptance criteria and reported device performance in terms of quantifiable metrics like sensitivity, specificity, accuracy, etc., are not applicable as this is a physical medical device, not an AI/software device with such performance metrics.

The performance testing mentioned is mechanical in nature, focused on demonstrating substantial equivalence to predicate devices.

• Comparison of manufacturing methods: Same manufacturing methods as predicate PST® Acetabular Shells.
• Comparison of design features: Same outer profile and porous structured surface as predicate PST® Acetabular Shells.
• Disassembly Testing: Per ASTM F1820, including push-out and torsional testing (for worst-case style and size of compatible Stryker Orthopaedics acetabular bearings). |
  | Compatibility | - Incorporates acetabular bearing mating features of predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells.
• Compatible with existing Stryker Orthopaedics acetabular bearings, including Trident polyethylene and Modular Dual Mobility (MDM) bearing families. |
  | Sterilization | Same sterilization methods as predicate PST® Acetabular Shells. |
  | Packaging | Similar packaging to predicate PST® Acetabular Shells. |

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 applicable to this device. The testing described is mechanical performance (e.g., disassembly testing per ASTM F1820) of physical components, not data analysis or clinical studies in the typical sense of AI/software device evaluation.

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. Ground truth, in the context of expert review for AI/software, is not relevant for the mechanical testing of a physical implant.

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

This information is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations for ground truth establishment, which is not relevant here.

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

This information is not applicable. MRMC studies are for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not relevant for an orthopedic implant.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

This information is not applicable. The "ground truth" for a physical device is its adherence to specified material properties, mechanical strength characteristics, and design specifications as evaluated through engineering tests, not clinical or pathological outcomes in the context of expert consensus as described for AI/software.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/software device.

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

This information is not applicable. There is no "training set."

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