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The Newfix Screw, Wire and Pin Fixation System is to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

The Newfix® Screw, Wire and Pin Fixation System is a family of threaded external fixator of various sizes for use in the treatment of fractures. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges. The pin and screws of the Newfix System are manufactured using implant grade stainless steel. Pin configurations include Kirschner Pins (K-wires), Schanz Screws, Steinmann Pin and Conic Threaded Bone Screws all in various lengths, diameters and threads. The Newfix® Screw, Wire and Pin Fixation System is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® Screw, Wire and Pin Fixation System includes the following accessory devices: Depth Gauge; Tissue Protection Triple Guide for Axial Fixation; T Shape Handle Chuck; and Drill Bits.

The provided document K101254, "Tecnología y Diseño Industrial, S.A. de C.V. Newfix Screw, Wire and Pin Fixation System Summary of Safety and Effectiveness," does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for performance claims (e.g., diagnostic accuracy, sensitivity, specificity, or other quantitative performance metrics for AI/ML devices).

This document is a 510(k) premarket notification for a medical device (bone fixation system), focusing on demonstrating substantial equivalence to a predicate device. The "Summary of Safety and Effectiveness" section details the device, its intended use, and a comparison to a predicate device, but it does not include any performance study data or acceptance criteria related to classification, diagnostic performance, or AI/ML efficacy.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details based on the provided text, as this information is not present. The document focuses on:

• Device Description: What the Newfix Screw, Wire and Pin Fixation System is, its components, materials, and sizes.
• Intended Use: How the device is meant to be used (fixation of bone fractures, fusion of joints, bone reconstructions, or as guide pins).
• Substantial Equivalence Comparison: A table comparing the Newfix system to a predicate device (Treu-Instrumente GmbH Bone Fixation Screws and Pins) based on intended use, materials, duration of use, reuse capability, fixation type, and sterility. This comparison is the primary method of demonstrating safety and effectiveness in this type of submission.

There is no mention of:

• Acceptance criteria for device performance.
• A study proving performance against such criteria.
• Sample sizes for test or training sets.
• Ground truth establishment.
• Expert involvement or adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.

This is a physical medical device (implants for bone fixation), not a diagnostic or AI/ML software device, which explains the absence of the requested performance study details.

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