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The DePuy ACE AIM® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique and spiral fractures, comminuted fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions metaphyseal fractures and epiphyseal fractures.

The DePuy ACE AIM® Titanium Tibial Nail is an intramedullary fixation rod for the fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 12mm and 13mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE AIM® Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5 cm to 43.5cm. The proximal end of the 10mm, 11mm, 12mm and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nails is I Imm in diameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws. The distal end of the nail contains two 5.0mm holes which accept 4.5mm solid cortical bone screws. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.

The DePuy ACE AIM® Titanium Tibial Nail is manufactured from Titanium 6Al-4V ELI (ASTM standard F-136)

This 510(k) summary (K970202) describes a medical device, the DePuy ACE AIM® Titanium Tibial Nail, which is an intramedullary bone fixation rod used for internal fixation of tibial fractures. It does not contain information related to software or AI/ML-based device performance, diagnostic accuracy, or clinical study outcomes in the way a modern AI/ML device submission would.

Therefore, I cannot provide the requested information in the format of acceptance criteria, device performance, and study details for an AI/ML device. The document describes a physical medical device and its substantial equivalence to a previously cleared version based on mechanical and material properties, and cadaveric testing related to insertion/extraction forces, not an AI/ML algorithm's diagnostic or predictive performance.

Here's why each point cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance: This document discusses design changes (distal bend) and materials for a physical implant. The "performance" mentioned relates to insertion/extraction forces in cadavers due to design modifications, not diagnostic metrics.
2. Sample sized used for the test set and the data provenance: The only "testing" mentioned is comparative testing on cadavers for insertion/extraction forces. No sample size for a "test set" in the context of an AI/ML algorithm is present, nor is data provenance like country of origin or retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no ground truth establishment for a test set in the context of diagnostic accuracy. The "ground truth" for this device would be its mechanical integrity, biocompatibility, and fit for its intended orthopedic purpose, confirmed through engineering testing and clinical experience with similar devices, not expert image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no diagnostic test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical implant, "ground truth" generally relates to its mechanical properties, material composition, and biological response, which are assessed through engineering standards, biocompatibility testing, and clinical observation over time. The document mentions "clinical usage," implying experience and outcomes.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) pertains to a traditional medical device (an orthopedic implant) and not an AI/ML-based software device. Therefore, the questions formulated for AI/ML device evaluation are not relevant to the provided text.

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