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Versacem is designed for use in total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polvarthritis or congenital hip dysplasia.
• · Avascular necrosis of the femoral head.
• · Acute traumatic fracture of the femoral head or neck.
• · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
  Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases:
• · Elderly patients or poor bone quality.
• · Revision for recurrent dislocation in elderly patients with poor bone quality.
• · Patients treated with radiotherapy or chemotherapy.
  Versacem is intended for cemented use only.

The purpose of this submission is to gain clearance for the Versacem Acetabular Shell and to add two new sizes of the compatible Double Mobility HC Liners previously cleared within K092265, K131458 and K143453.
The Versacem Acetabular Shell implants and the Double Mobility HC liners are sterile, individually packaged, implantable medical devices intended to be used in Total Hip Arthroplasty.
The devices subject of this submission are:

• . Versacem Acetabular Shell from size Ø40 to size Ø56;
• . Double Mobility HC liner Ø22.2/DMAZ;
• Double Mobility HC liner Ø28/DMC. ●

The provided document is a 510(k) premarket notification from the FDA, clearing the Medacta International S.A. Versacem Acetabular Shell and Double Mobility HC Liners. This type of document does not contain the acceptance criteria or detailed study results for device performance as would be found in a clinical trial report or a comprehensive engineering report.

The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving de novo safety and efficacy against predefined clinical acceptance criteria. The "Performance Data" section in the document only lists the types of non-clinical (bench) tests performed.

Therefore, I cannot fulfill most of the requested information based on this document. Below is a breakdown of what can be inferred or what is explicitly stated, and what cannot be provided:

Inferences/Provided Information from the Document:

• Study That "Proves" Device Meets Acceptance Criteria: The document refers to "Performance Data" from "Nonclinical Studies" (bench testing) to support substantial equivalence. These studies include:
  • Design Validation
  • Wear Test
  • Range of Motion Evaluation
  • Fatigue Test
  • Pull-off and Lever-out Tests (for liner)
  • Evaluation of Jumping Distance
  • Evaluation of Impingement Risk
  • Pyrogenicity testing (LAL test, in-vivo evaluation in rabbit)
  • Biocompatibility assessment
  • Shelf-life evaluation

Information NOT available in this document:

• A table of acceptance criteria and the reported device performance: This document only lists the types of tests performed, not the specific acceptance criteria for each test nor the quantitative results. For example, it lists "Wear Test" but doesn't state the acceptable wear rate or the actual wear rate achieved.
• Sample sizes used for the test set and the data provenance: Bench testing results typically refer to the number of samples tested (e.g., how many shells, how many liners), but this is not provided. Data provenance is not applicable as these are bench tests, not clinical studies with human data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as these are non-clinical, mechanical/material performance tests, not studies requiring expert interpretation of clinical data or images.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for a medical device (hip implant), not an AI/imaging device that would involve human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically engineering and material science standards (e.g., force applied, displacement, wear volume, fatigue cycles to failure). These are implied by the test names (e.g., "Fatigue Test" implies testing to a certain number of cycles or until failure, compared against a standard).
• The sample size for the training set: Not applicable. These are physical devices, not AI algorithms trained on data.
• How the ground truth for the training set was established: Not applicable.

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