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The SALVATION™ Beams and Bolts System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).

The SALVATION™ Fusion Beams and Bolts System consists of titanium alloy screws and bolts used for midfoot reconstruction. The system features both solid core and cannulated options in various diameters and lengths.

The presented document is a 510(k) summary for the SALVATION™ Beams and Bolts System, a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to pre-existing devices rather than on performing a standalone clinical study to establish acceptance criteria or device performance based on human reader studies or ground truth.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available within this document.

This 510(k) relies on non-clinical evidence to demonstrate substantial equivalence, as explicitly stated:

(b)(1). Substantial Equivalence - Non-Clinical Evidence

"Performance testing and analysis that demonstrated substantial equivalence includes insertion, removal, pull-out and ultimate torque, as well as cross-sectional analysis and four point bending."

(b)(2). Substantial Equivalence - Clinical Evidence N/A

This clearly indicates that no clinical studies were performed for this submission.

As a result, I cannot populate the table or provide the requested details regarding a study that proves the device meets acceptance criteria as described in your prompt because such a study (in the context of clinical performance, human-in-the-loop, or standalone algorithm performance) was not part of this 510(k) submission. The device's "performance" for regulatory purposes here is based on engineering and material testing comparisons to predicate devices.

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