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The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.

The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).

The provided text is a 510(k) summary for the In2Bones IBS-B MIS Beveled Screw System, which is a medical device for bone fixation. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-based device as implied by the detailed questions (e.g., number of experts, MRMC study, training set ground truth).

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel or AI-driven device.

Here's why the requested information cannot be extracted from the provided text:

• Type of Device: The IBS-B MIS Beveled Screw System is a physical implant (screws for bone fixation) made of titanium alloy. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or require ground truth established by experts or MRMC studies.
• Performance Testing: The document states that "Engineering analysis was utilized to compare the IBS-B MIS Beveled Screw System to the predicate devices to support substantial equivalence with regard to mechanical performance." It also mentions validation "per ISO 11137-2 for gamma sterilization." This refers to mechanical integrity and sterility, not diagnostic or AI-driven performance.
• Substantial Equivalence: The entire submission hinges on showing that the new device is "substantially equivalent" to existing, legally marketed devices in terms of indications, materials, and geometry. This approach generally does not require extensive clinical trials or performance studies with acceptance criteria as would be needed for a de novo or new AI/ML device.

Therefore, I cannot provide the requested table and study details because the provided document does not pertain to an AI/algorithm-based device and focuses on substantial equivalence for a physical medical implant.

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