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The iNSitu Total Hip System is indicated for use 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 iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

The iNSitu Total Hip Replacement System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular cups (additively manufactured), acetabular liners (Vitamin E polyethylene), acetabular bone screws, screw hole covers for the scetabular cups, and apical hole covers for the apical hole in the acetabular cups.

This document describes the pre-market notification for the iNSitu Total Hip System, a medical device. The provided text, however, focuses on demonstrating substantial equivalence to predicate devices through performance testing, rather than establishing acceptance criteria and proving an AI device meets them.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithm-based device because the provided document does not describe an AI or algorithm-based device. It pertains to a physical medical implant system (a total hip replacement system).

The document describes the following for the iNSitu Total Hip System:

• Intended Use: Total hip replacement due to osteoarthritis, rheumatoid arthritis, avascular necrosis, congenital hip dysplasia, acute traumatic fracture, or failed previous hip surgery. The femoral stem and acetabular cup are intended for cementless fixation.
• Technological Characteristics: Manufactured from titanium alloy, packaged and sterilized using similar processes to predicate devices.
• Performance Testing (Preclinical): Extensive mechanical testing was conducted to evaluate the device and demonstrate substantial equivalence to predicate devices. This testing included:
  • Modular acetabular component disassembly (liner push-out, offset pull-out, torsional testing on worst-case sizes).
  • Torsional and fixation strength and removal torque of acetabular bone screws.
  • Characterization of physical, mechanical, thermal, cross-link, and oxidation properties of the highly cross-linked vitamin E stabilized UHMWPE.
  • Hip wear simulator testing on worst-case components.
  • Impingement testing on worst-case components.
  • Range of motion evaluation (flexion/extension, abduction/adduction, internal/external rotation).
  • Characterization of porous structured titanium (in accordance with FDA Guidance "Guidance Document for Testing Orthopedic Implants with Surfaces Apposing Bone or Bone Cement").
  • Physical and mechanical properties of the AM titanium alloy solid implant substrate (non-porous base material).
  • Unsupported fatigue test on the acetabular cup.
  • Mechanical and fatigue testing of ceramic femoral heads.
  • Disassembly testing of the femoral head/femoral taper (with CoCr and ceramic femoral heads).
  • Fatigue testing of the worst-case femoral hip stem.
  • Fatigue testing of the neck region of the worst-case femoral hip stem.
  • Bacterial Endotoxins Test (BET), chromogenic kinetic method.

Conclusion stated in the document: The described performance testing demonstrates that the iNSitu Total Hip System is substantially equivalent to the predicate systems based on its indications for use, design features, and technological characteristics.

To elaborate on why the specific questions in the prompt cannot be answered with the provided text:

• AI/Algorithm Device: The iNSitu Total Hip System is not an AI or algorithm-based device. It is a physical implant. Therefore, concepts like "AI assistance," "human-in-the-loop performance," "training set," "test set," "ground truth," and "experts establishing ground truth" are not applicable in this context.
• Acceptance Criteria for AI Performance: The document provides performance testing results for mechanical properties and biocompatibility of the hip implant, not diagnostic or predictive performance metrics of an AI.
• Sample Size for Test Set/Data Provenance/Ground Truth: These are AI/algorithm-specific concepts. For a physical device, testing involves material science and mechanical engineering principles, often using specialized test fixtures and standardized protocols rather than patient data sets in the way AI devices do.
• MRMC Study/Effect Size: These are relevant for AI-assisted diagnostic tools where human performance with and without AI is compared. This is not applicable to a hip implant.
• Standalone Performance: For a physical device, this would refer to its performance characteristics (e.g., strength, wear resistance) independent of surgical technique, which is covered by the mechanical testing. However, it's not the "standalone (algorithm only)" concept implied by the question.

In summary, the provided text describes a medical device clearance based on mechanical and material testing to demonstrate substantial equivalence, not an AI device validation study.

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