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The indications for use of the K3 Bone Screw System™ are fixation/stabilization of small bones in hand or small bones in mid and forefoot fractures.

The KMI K3 Bone Screw System'™ will be offered in Ti-6AI-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of fifthteen screw lengths will be made available in 3.5 mm diameter (12-50 mm), and eight screw lengths will be made available in the 3.5 mm solid (12-26 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.

The provided text describes the K3 Bone Screw System™ and details its intended use, regulatory standing, and comparison to existing devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the document focuses on:

• Substantial Equivalence: The primary "proof" offered is that the K3 Bone Screw System™ is substantially equivalent to other orthopedic screws already on the market and approved by the FDA. This is a regulatory pathway for devices that are very similar to already legally marketed devices.
• Voluntary Standards: The material (titanium alloy 6AL-4V ELI) used to manufacture the screws meets chemical and mechanical requirements specified in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84, ASTM B348-83, F136-84, F67-88). The instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
• Clinical History: It highlights that bone screw systems in general have been used for many years, and their clinical performance is well known and documented over 75 years of clinical evaluation.

Therefore, I cannot fill out the requested table and answer the study-specific questions as the document does not contain that information. It does not describe a performance study with specific acceptance criteria, sample sizes, expert involvement, or comparative effectiveness.

The document's purpose is to satisfy an FDA Notification for a Summary of Safety and Effectiveness Information, primarily by demonstrating substantial equivalence, not by presenting a performance study with specific, quantifiable acceptance criteria and results.

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