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Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

The 3.7mm / 5.0mm Dynamic Locking Screws are similar to locking screws, but feature a pin-in sleeve design. This design allows for micro movement within the angularly stable system and the screw-plate interface. The motion is contained within the DLS. The DLS are designed to be used with all applicable legally marketed Synthes Locking Compression Plates (LCP).

The provided text is a 510(k) summary for the Synthes 3.7mm / 5.0mm Dynamic Locking Screws. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe acceptance criteria for an AI/ML powered device or a study comparing its performance to those criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, nor can I provide information about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not present in the provided text.

The document describes the device, its intended use, and the basis for its substantial equivalence to predicate devices, focusing on mechanical and functional testing for a traditional physical medical device, not software or AI/ML. The "acceptance criteria" discussed are in the context of demonstrating mechanical strength and functional properties comparable to predicate devices.

Summary of what is present in the document:

• Device: Synthes 3.7mm / 5.0mm Dynamic Locking Screws, designed to allow micro-movement within an angularly stable system.
• Intended Use: In combination with Synthes Locking Compression Plates (LCP) for long bone fractures, fixation of osteopenic bone, osteotomies, non-unions, and malunions.
• Proof of Concept/Substantial Equivalence: Functional and mechanical testing was conducted to demonstrate comparable mechanical and functional properties to predicate devices.
  • Specific tests mentioned: fatigue strength, insertion torque, fretting corrosion, and pullout resistance.
  • An in vivo ovine tibial osteotomy model was used to demonstrate a lack of adverse effects on bone healing compared to a predicate device.

To reiterate, none of the information requested regarding AI/ML device performance criteria or studies is available in this 510(k) summary.

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