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The OSStaple™ Chill is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy.

The OSStaple M Chill is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is. then transformed by body heat after insertion, and contracts to a "closed" austenitic state. The OSStaple TM Chill differs from the OSStaple TM in that the staples:do not require any external heating; they are completely transformed by body heat. The OSStaple! 100 Chill also includes staples with smooth and barbed legs to achieve increased pull-out resistance: All other characteristics of the implant are identical to the OSStapleTM predicate.

This is a medical device 510(k) premarket notification for a bone staple. It does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to software or AI/ML performance. Therefore, I cannot provide the requested information about AI/ML device performance.

The document describes the OSStaple™ Chill, a nitinol implant for bone fixation. The "Device Description and Testing" section mentions "Bench testing of the OSStaple™ Chill showed that the implants remain in their open martensitic state at operating room temperatures (20°C - 24°C), and fully transform to their closed shape by body temperature (37°C). Testing also showed that both the smooth and barbed versions of the OSStaple™ Chill achieve equivalent or superior pullout resistance to the OSStaple™."

This relates to the physical and mechanical properties of the staple, not to an AI/ML device.

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