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The Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction in forefoot surgery.

The Snap-Off Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.

The Snap-Off Self-Compressive Screw consists of screws available in several lengths.

All the implants are made of titanium alloy.

The fixation is provided thanks to the threading of the screw, which allows compression.

This document describes a 510(k) premarket notification for the "Snap-Off Self-Compressive Screw" by Neosteo. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effectiveness of an AI/ML-based device.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Fixation of bone reconstruction in forefoot surgery.
• Design: Self-compressive screws of various lengths.
• Materials: Titanium alloy per ASTM F136.
• Mechanical Safety and Performance: Resistance to torsion and pull-out strength.

The "Non-Clinical Test Summary" section mentions that resistance to torsion (according to ASTM F543 Annex 1) and pull-out strength (according to ASTM F543 Annex 3) tests were performed. It states, "The results of these testing indicate that the current Snap-Off Self-Compressive Screw is equivalent to predicate devices." However, it does not provide specific acceptance criteria or the reported performance data from these tests.

The "Clinical Test Summary" explicitly states, "No clinical studies were performed." Therefore, there is no information about human readers, AI assistance, ground truth establishment for clinical data, or effect sizes.

To answer your request, I must state that the provided text does not contain the requested information regarding acceptance criteria and performance study details typical for an AI/ML device. The document is a 510(k) summary for a physical medical device (bone screw) seeking substantial equivalence, not an AI/ML diagnostic or assistive device that would have performance metrics like sensitivity, specificity, or human improvement with AI.

Therefore, I cannot populate the table or provide details for points 1-9 as they pertain to AI/ML device evaluation criteria, which are not present in this document.

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