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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 is a modular system that consists of various components including clamps, distractors, pins, carbon fiber rod, and stainless steel tubes for use in orthopedic and trauma treatment. The system is a modular design to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of aluminum and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and stainless steel and carbon fiber connector rods. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges. 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 study information for the Tecnolgia y Diseño Industrial, S.A.P.I. de C.V Newfix® External Fixation System K101338, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices through performance testing based on recognized standards. The key performance tests relate to the locking mechanism of the external fixation system.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantitative performance targets or thresholds for each component. The primary acceptance criterion is that the Newfix® system's locking mechanisms perform equivalently to those of the predicate devices when tested against the specified ASTM standard.

Study Information

Due to the nature of a 510(k) summary for a Class II medical device like an external fixation system, the "study" primarily consists of mechanical performance testing rather than clinical trials with human subjects.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set:
     • TDI Products tested:
       • E0300104 Lateral Cylinder for Pins (Straight Clamp)
       • E0600201 T-Shaped Clamp
       • E0600301 Angled Clamp
       • E0600401 Ankle Clamp
       • E0900104/5 RadioLucent Wrist Axial Fixator Clamp
     • Predicate Devices tested:
       • Orthofix ProCallus Fixator Straight Clamp
       • Orthofix T-Shaped Clamp
       • Orthofix Ankle Clamp
       • Orthofix RadioLucent Wrist Fixator Clamp
     • Materials used for testing:
       • Ø6mm (0.236in) and Ø4mm (0.157in) series 316 stainless steel rods.
       • Ø6mm (0.236in) and Ø4mm (0.157in) series 316 stainless steel rods with a hexagonal nut for torque tests.
       • Socket Set Screws Flat Point ISO 4026 M8x1.25.
   • Data Provenance: The testing was conducted by Tecnolgia y Diseño Industrial, S.A.P.I. de C.V. (located in Zapopan, Jalisco, Mexico) using their own products and commercially available predicate devices. The location of the testing laboratory is implied to be within their facilities, but a specific country of origin for the data itself beyond the manufacturer's location is not specified. This is a retrospective study in the sense that it compares a new device to existing predicate devices, but it involves prospective mechanical testing to generate new performance data.

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

   • This type of mechanical performance testing does not involve human experts establishing "ground truth" in the clinical sense (e.g., diagnosing a condition from an image). The "ground truth" for mechanical testing is based on established engineering standards (ASTM F 1541, ASTM E 4) and the performance characteristics of the legally marketed predicate devices. The "experts" involved would be the engineers and technicians performing the tests and analyzing the data to ensure compliance with the standards and equivalence to predicate performance. Their specific qualifications are not detailed in this summary.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human interpretation of medical images or outcomes, to reconcile differing opinions among experts. This submission describes mechanical testing.

4. 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:

   • Not applicable. This is a 510(k) submission for a physical medical device (external fixation system), not an AI/imaging diagnostic device.

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

   • Not applicable. This is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the performance testing is based on:
     • Engineering standards: ASTM F 1541 (Standard Specification and Test Methods for External Skeletal Fixation Devices) and ASTM E 4 (Practices for Force Verification of Testing Machines).
     • Performance of legally marketed predicate devices: The Newfix® system's locking mechanisms are shown to be equivalent to those of the identified Orthofix predicate devices.

7. The sample size for the training set:

   • Not applicable. This describes performance testing for a physical medical device, not a machine learning model that requires a training set. The device itself is manufactured, and its components are subjected to testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a machine learning model.

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