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The VERTICALE® Triangular Fixation System, when used in combination with the VERTICALE® Posterior Spinal Fixation System, is intended for immobilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® Triangular Fixation System is intended to treat the following conditions: trauma (i.e., fracture or dislocation); tumor, pseudoarthrosis; and failed previous fusion.

The VERTICALE® Triangular Fixation System is intended for iliac fixation and must be attached to the VERTICALE® Posterior Spinal Fixation System to treat the conditions listed above.

Refer to the labeling for the VERTICALE® Posterior Spinal Fixation System for limitations and instructions for use.

The VERTICALE® Triangular Fixation System consists of iliac screws with a UHMWPE lined slot, a polyaxial head as well as related instruments. The VERTICALE® Triangular Fixation System is intended to be used with VERTICALE® Posterior Spinal Fixation System (K171421).

The implants of the VERTICALE Triangular Fixation System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and Ultra-High-Molecular-Weight Polyethylene according to ASTM F648 / ISO 5834-1 and -2.

The provided text describes a 510(k) premarket notification for a medical device called the "VERTICALE® Triangular Fixation System." However, the document focuses on regulatory approval based on substantial equivalence to predicate devices through non-clinical testing and engineering rationales, rather than a clinical study evaluating AI software or diagnostic performance against specific acceptance criteria for an AI/ML device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.

The listed aspects in your prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, ground truth types) are typically associated with the rigorous validation of AI/ML-driven medical devices. This document describes a more traditional mechanical device approval process based on non-clinical performance testing (e.g., strength, durability).

To directly answer your prompt, I would need a different type of document, specifically one detailing the clinical or technical validation of an AI/ML medical device.

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