Search Results

The MedShape DynaClip™ Bone Staple is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The proposed MedShape DynaClip Bone Staple is a sterile, single use orthopedic implant designed to use the principles of interference fit to hold the implant body into a predrilled hole and across the target fracture site. The DynaClip Bone Staple is intended to be implanted in the bones of the hand or foot and is comprised of Nickel Titanium alloy commonly referred to as NiTiNOL (reference ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The staple is provided pre-loaded on a disposable inserter.

The provided text describes a 510(k) premarket notification for the MedShape DynaClip™ Bone Staple, a medical device for bone fixation. It details the device's characteristics, indications for use, and a comparison to a predicate device, focusing on the rationale for substantial equivalence.

However, the document does not contain any information about an AI/algorithm-based device, human reader studies, or the establishment of ground truth by expert consensus or other methods. It describes a traditional medical device (bone staple) that undergoes mechanical and material testing, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/algorithm device meets those criteria based on the provided text. The questions you posed are relevant to AI-based medical devices, which this document does not cover.

Ask a specific question about this device