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CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

CREED™ Cannulated Screws Subject device consists of components that will be available in Ø2.5mm thread diameter and lengths ranging from 20-44 mm. They areheadless compression screws. All screws are self-drilling and self-tapping. The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.

This document is a 510(k) Premarket Notification from the FDA regarding the "CREED™ Cannulated Screws." It is a premarket submission for a medical device and, as such, does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence of a new medical device (CREED™ Cannulated Screws) to a legally marketed predicate device (also CREED™ Cannulated Screws, K200291) based on mechanical performance and material characteristics, not on clinical outcomes or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria for diagnostic performance
• Study proving device meets acceptance criteria (in the context of diagnostic performance)
• Sample size for test set or data provenance
• Number of experts or their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for training set
• How ground truth for training set was established

The "Performance Data" section explicitly states: "Static bending (ASTM F1264) test results were presented along with engineering rationale for other relevant measures." This indicates that the performance evaluation was based on mechanical testing, not clinical or diagnostic studies.

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