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Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM® Liners
Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner
The Trident® Constrained Acetabular Insert is indicated for use in primary and revision 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.
The Trident® II Acetabular Shells are indicated for cementless use only.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

This document is a 510(k) summary for the Stryker Orthopaedics Trident® II Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of an acetabular dome hole plug option.

Based on the provided text, the device is a medical implant, not an AI/ML powered device, and therefore the request to describe acceptance criteria and associated studies for an AI/ML device is not applicable.

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

• No AI/ML Component: The device described, the Trident® II Acetabular System, is a hip joint prosthesis. The document discusses its components (shells, screws, liners, dome hole plugs), intended use, indications for use, and a comparison to predicate devices, all of which are characteristic of traditional medical devices. There is no mention of artificial intelligence, machine learning, software algorithms for image analysis, or any computational diagnostic or prognostic functionality.
• Focus on Substantial Equivalence for a Physical Component: The primary purpose of this 510(k) filing is to add an "additional dome hole plug option." The entire "Non-Clinical Testing" section explicitly states "No new non-clinical testing was performed." Instead, it references analyses for "equivalence in dimensions and MR evaluation" and prior bacterial endotoxin testing. This is typical for a minor modification to an already cleared physical device, not for a new AI/ML product.

Therefore, the following information points from your request are not present because they relate to the evaluation of an AI-powered medical device:

1. A table of acceptance criteria and the reported device performance: Not applicable.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Stand-alone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document describes a physical medical device (hip implant components) and its regulatory clearance process, which does not involve the type of AI/ML performance evaluation criteria and studies you are inquiring about.

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