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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® 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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