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The MedShape DynaClip Bone Staple is intended to be used for the following:

• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

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 used for fracture and osteotomy fixation, including joint arthrodesis, and fixation of small bone fragments, 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 is a 510(k) summary for the MedShape DynaClip Bone Staple. This document describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. It does not describe an AI/ML powered medical device, nor does it contain information typically found in studies related to AI/ML device acceptance criteria.

Specifically, the document focuses on bench testing for a physical orthopedic implant. Therefore, the questions regarding acceptance criteria and studies that prove an AI device meets acceptance criteria (such as sample sizes for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable to this document.

The document states: "No clinical data was collected, as it was deemed unnecessary to support the assertion of safety and effectiveness." This further reinforces that there was no study involving human readers or AI algorithms as would be expected for an AI/ML device.

Therefore, an answer based on the provided text cannot fulfill the user's request, as the request is predicated on the assumption of an AI-powered device, which the MedShape DynaClip Bone Staple is not.

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