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The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use with the Pinnacle® Acetabular cup System, the Pinnacle® Bantam Acetabular Cup System and the Pinnacle® Revision Acetabular Cup System for total hip replacement in the following conditions:

I. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled augment/acetabular cup construct is intended for cemented or cementless use. .

The porous Gription TF titanium shim is affixed to the mating bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The Gription TF titanium buttress/shim is affixed to the bone using bone cement or mechanical screw fixation. The assembled buttress/acetabular cup construct is intended for cemented or cementless use.

Device Description

The subject devices represent sterile screws with additional lengths to allow surgeons more flexibility for the fixation of the acetabular augments, buttresses, and shims. Specifically, the lengths include 14-24mm in increments of 2mm and lengths 25-70mm in increments of 5mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the DePuy Gription® TF 5.5mm Sterile Locking Screws, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Device Performance (How the device met the criteria)
Material Equivalence	The device is made of TI-6AL-4V-ELI, which is the same material as the comparable screws of the predicate device (DePuy Universal Gription TF Cones and Acetabular Augment System 5.5mm Cancellous Locking, Non-Sterile Screws, K100391).
Head Geometry Equivalence	The device has a "Locking" head geometry, which is the same as the comparable screws of the predicate device.
Major Diameter Equivalence	The device has a major diameter of 5.5mm, which is the same as the comparable screws of the predicate device.
Functional Equivalence	"Push out testing of subject device screws" was performed to demonstrate that the expanded lengths maintain equivalent performance (implied by the conclusion of substantial equivalence).
Mechanical Strength/Integrity	"Print review" and "tolerance analysis" were conducted, indicating verification of design specifications and fit, which are critical for mechanical performance.
Substantial Equivalence to Predicate Device	Based on "print review, tolerance analysis, and push out testing," the non-clinical tests concluded that the subject device is substantially equivalent to the predicate device, implying it meets all performance aspects relevant for its intended use.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the test set.
- The data provenance is not explicitly stated. The tests conducted are "Print review, tolerance analysis, and push out testing of subject device screws," which are likely performed in a laboratory setting by the manufacturer (DePuy Orthopaedics, Inc.) in the USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The tests seem to be engineering and mechanical performance tests rather than those requiring expert ground truth in a clinical sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. The tests mentioned are objective engineering tests rather than subjective assessments requiring adjudication.
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:
- No MRMC study was conducted. This device is a medical screw, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical screw.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be engineering specifications, material properties, and mechanical test results (e.g., force required for push-out, dimensional tolerances). It's based on established engineering standards for medical devices of this type, rather than clinical outcomes or pathology.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a "training set." The development of the device would rely on engineering principles, design specifications, and manufacturing processes, rather than a data-driven training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set. The design and validation of the device rely on established engineering principles, material science, and manufacturing quality control.

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