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The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.

The VAN Hip Fracture System includes short and long intramedullary nails, lag screws and distal locking cortical bone screws. The nail contains an angle adjust feature that allows for the neck/shaft angle to be adjusted to accommodate anatomical variations in the femoral neck angle.

The provided text describes a medical device, the VAN Hip Fracture System, and its regulatory clearance process, focusing on substantial equivalence to predicate devices. It does not contain information related to an AI/ML powered device, nor does it detail a study with acceptance criteria, device performance, or human reader effectiveness in the way typically associated with such devices.

Therefore, I cannot fulfill your request for the specific information points you've outlined, as they are not present in the provided document. The document describes a traditional medical device (an intramedullary fixation rod) and its pre-clinical mechanical testing, not a diagnostic or prognostic AI/ML system.

The "Preclinical Testing" section {1} states:
"Static and dynamic mechanical testing was performed on the VAN Hip Fracture System in accordance with ASTM F384, Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices. The results demonstrate that the VAN Hip Fracture System is substantially equivalent to a predicate device in side-by-side testing."

This indicates that:

• Acceptance Criteria: Based on "substantial equivalence" to a predicate device in mechanical performance as defined by ASTM F384. The specific numerical criteria for static and dynamic mechanical properties are not detailed in the provided text, but would be expected to match or exceed those of the predicate.
• Device Performance: The device's performance "demonstrate[s] that the VAN Hip Fracture System is substantially equivalent to a predicate device." Again, specific numerical performance metrics are not provided.
• Study Type: Mechanical testing, not a clinical or AI-centric study.

Given the nature of the document, the following points you requested cannot be addressed:

• Table of acceptance criteria and reported device performance: Not explicitly stated in the provided text (only general statement of "substantial equivalence").
• Sample sized used for the test set and the data provenance: Not applicable; this was mechanical testing, not a data-driven study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study, effect size: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable (mechanical properties compared to a predicate, not clinical ground truth).
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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