Search Results

The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavice including osteopenic bone.

The A.L.P.S. Clavicle Plating System is designed to address fractures of the clavicle. The system is comprised of plates, screws, and instruments to facilitate the installation of the implants.

The provided text is a 510(k) summary for the A.L.P.S. Clavicle Plating System. This document is related to a medical device (bone fixation appliance), not an AI/Software as a Medical Device (SaMD) or a diagnostic device.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD performance metrics (like sensitivity, specificity, AUC), "test sets," "ground truth by experts," "MRMC studies," etc., as requested in your prompt, are not applicable to this submission.

This 510(k) focuses on demonstrating substantial equivalence to a predicate device (K173767, also an A.L.P.S. Clavicle Plating System by Biomet Inc.) based on:

• Identical intended use and indications for use.
• Similar technological characteristics (materials, design features, sterilization).
• Non-clinical tests (Guide Comparison, Drilling Test) to validate a design change to a soft tissue guide, aimed at improving safety and effectiveness without altering the fundamental mode of action or indications.

The document explicitly states "Clinical Tests: NA" (Not Applicable). This further confirms that there were no human subject studies or performance evaluations in the way one would typically assess an AI/SaMD.

In summary, your prompt's questions are designed for AI/SaMD products, and this 510(k) submission is for a physical orthopedic implant. As such, I cannot extract the information you are requesting from this document.

Ask a specific question about this device