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The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The PhantomTM Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The PhantomTM Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The PhantomTM nails are offered in a variety of lengths to accommodate variations in patient anatomy. The PhantomTM threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

This document is a 510(k) summary for the Phantom™ Small Bone Intramedullary Nail System, a medical device. It does not describe an AI/ML powered device, therefore the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly with respect to AI/ML specific aspects (like sample size for test/training set, expert ground truth, MRMC studies, standalone performance), is not present in the provided text.

However, I can extract information regarding the device's mechanical performance testing and its acceptance criteria as implied by the comparison to a predicate device.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria, but it describes the type of testing performed and the conclusion drawn from it. The acceptance is implied by the "substantially equivalent" determination.

Regarding the other requested information, the document does not contain:

2. Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI/ML system tested on data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For mechanical testing, the "ground truth" is measured physical properties and performance under specific conditions as defined by ASTM standards.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The study proving the device meets acceptance criteria was a series of mechanical tests on the worst-case configurations of the Phantom™ nail, locking screws, and threaded pegs. These tests were conducted according to ASTM F382 (for static and dynamic bending of the nail) and ASTM F543 (for torsion, insertion/removal, and pullout of the screws/pegs). The acceptance criteria were met by demonstrating substantial equivalence in mechanical performance and technological characteristics to the predicate device, the ParaLock Plating System™ (K140397). The document does not specify the exact number of units tested for mechanical properties, or the numerical thresholds for passing, but rather states that the comparison demonstrated substantial equivalence.

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