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The DePuy Ace™ VersaNail Tibial Nail is indicated for the internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

The Tibial Nail is intended for bone fixation in the management of fractures and reconstructive surgeries.

Non-weight bearing bone fixation is indicated in the following conditions:

• Transverse, oblique, spiral, segmental and comminuted fractures;
• Fractures with bone loss and bone transport;
• Open fractures, pathologic fractures;
• Corrective osteotomies;
• Pseudarthrosis of the tibial shaft;
• Nonunions, malunions, metaphyseal and epiphyseal fractures.

The DePuy Ace™ VersaNail Tibial Nail is a cannulated intramedullary nail available in diameters of 8mm, 9mm, 11mm, 12mm and 13mm, and lengths of 24.0cm to 43.5cm. There are two holes on the proximal end and three holes on the distal end of the nail that allow for cortical bone screw locking. Screw hole diameters are 5.97mm at the proximal and distal ends respectively. The proximal end of the nail also features a 13mm medial/lateral (M/L) slot for dynamization, and an 8-degree bend with a bend radius of approximately 2.25mm. The distal end also has a bend radius of approximately 2.25mm and has a bullet tip. The DePuy Ace™ VersaNail Tibial Nail is intended for intramedullary fixation of tibial fractures.

This document does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is a 510(k) summary for a medical device (DePuy Ace™ VersaNail Tibial Nail) seeking clearance based on substantial equivalence to a predicate device.

Here's what the document does provide, and why it doesn't answer your specific questions:

• Device Description and Intended Use: It details the physical characteristics of the tibial nail and lists the types of tibial fractures it's intended to fix.
• Basis of Substantial Equivalence: It explicitly states that the device is substantially equivalent to a previously cleared device (DePuy Ace™ Bio Win Tibial Nail, K013430) and highlights the minor design differences between them.
• Regulatory Information: It includes the 510(k) contact, trade name, common name, classification, product code, and the FDA's clearance letter.

Why the requested information is absent:

• Acceptance Criteria and Device Performance Table: This type of table is typically found in a clinical study report or a detailed design verification/validation report, which are not usually included in the public 510(k) summary. For devices cleared via the 510(k) pathway, particularly those with a predicate device, the primary "proof" is demonstrating substantial equivalence, often through design comparisons, material testing, and sometimes bench testing, rather than a full-scale clinical trial with pre-defined acceptance criteria for performance metrics like sensitivity, specificity, etc.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC Study, Standalone Study, Ground Truth: These are all elements of clinical performance studies or specific testing methodologies (like evaluating AI/algorithm performance) that are not required for a typical orthopedic implant 510(k) submission, especially one where the design changes are minor and the predicate device has established safety and effectiveness. The focus here is on mechanical properties and biocompatibility, not diagnostic accuracy or human-AI interaction.
• Training Set Information: This is relevant for machine learning algorithms, which are not applicable to the DePuy Ace™ VersaNail Tibial Nail as described.

In summary, the provided text is a regulatory clearance document based on substantial equivalence, not a study report demonstrating specific performance against acceptance criteria for an AI or diagnostic device. Therefore, I cannot extract the requested information from this document.

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