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The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.

The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.

The Tecnología y Diseño Industrial, S.A. de C.V. Newfix® External Fixation System consists of various components including fixators, clamps, bars, distractors, carbon fiber rod, and stainless steel rods for use in orthopedic and trauma treatments.

TDI's Newfix® External Fixation System (Newfix External Fixation System 4.1 K101338 and Newfix Screws, Wires and Pins K101254 and this submission under review) consists of bone screws, pins and wires and external fixation components and lengthening systems. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft fissue and into the bone. The fixator frame of the Newfix® External Fixation System is attached to the shanks of the bone screws. The intended use and product technology of this submission have not changed from the earlier cleared submissions.

The present submission adds axial and pelvic fixation devices (including radiolucent wrist fixator), straight and angled clamps and rail lengthening transport systems.

The Newfix® External Fixation System is supplied non sterile and is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® External Fixation System includes instruments and accessory devices necessary for its use.

Here's a breakdown of the acceptance criteria and the study details for the Newfix® External Fixation System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set (e.g., number of devices tested). It lists the specific TDI products and predicate devices that were tested, but not the quantity of each or the number of tests performed.
• Data Provenance: The origin of the data is not explicitly stated in terms of country or retrospective/prospective. Given that the applicant is from Mexico, it's possible that the testing was conducted there, but this is not confirmed. The testing seems to be prospective in nature, as it involves physical performance tests of manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the study did not involve human interpretation or subjective assessment of medical images or patient data to establish ground truth. The "ground truth" here is objective performance data (e.g., locking mechanism integrity, absence of loosening) derived from mechanical testing, measured against established engineering standards (ASTM).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in human expert interpretations (e.g., in medical image reading studies). The current study involves physical performance testing with objective measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This submission is for a physical medical device (an external fixation system), not an AI/software device that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's mechanical integrity and functionality on its own.

7. The Type of Ground Truth Used

The ground truth used was objective performance data based on established engineering standards and comparative testing against predicate devices. Specifically:

• Measurement of locking mechanism function and integrity.
• Observation of component loosening.
• Compliance with "worst-case construct" testing outlined in ASTM F1541.
• Comparison of performance characteristics to legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device. The concept of "training set" is relevant for machine learning algorithms, not for the mechanical validation of medical hardware. The design and manufacturing processes are iteratively refined rather than "trained."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as #8.

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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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