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The Vilex External Fixation System is intended for external fixation with the following indications:

• · Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Arthrodesis
• · Adult and Pediatric Leg Lengthening
• · Correction of Bone Deformity in Upper & Lower Extremities

The Dynex Micro® falls within the Vilex External Fixation System product line. The system consists of the following components:

• Half pins and pins;
• Guidewires; ●
• External fixation rails; and ●
• Instruments.
  The half pins are constructed from stainless steel (ASTM F138 LVM) and are provided in multiple diameters (2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 mm) and lengths (60 - 175 mm). The transfixation pins, also constructed from stainless steel, and are provided in three diameters (2.5, 3.0, and 5.0 mm) and two lengths (250 mm and 350 mm).
  Guidewires are available in 1.1 mm and 1.6 mm diameter configurations and range in length from 60 - 150 mm.
  The mini- and mono- rails are manufactured from stainless steel and aluminum and are provided in various sizes (100 - 300 mm) to accommodate variations in patient size.
  The Dynex Micro® components are used with general and dedicated surgical instruments such as drill guides, drills, drill sleeves, wrenches, pin inserters, guide wire holders, and removal tools.

This document is a 510(k) premarket notification for the Dynex Micro® device, asserting its substantial equivalence to a previously cleared predicate device (X-Fix, K052196). The key takeaway regarding acceptance criteria and performance is that no new performance data or studies were required or conducted because the Dynex Micro® is essentially the same device as the predicate, with only a change in trade name.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, ground truth establishment, expert involvement, and MRMC studies, is not applicable in this specific case. The FDA's determination of substantial equivalence here is based on the identity of the device's technical characteristics to the predicate rather than new performance testing against specific acceptance criteria.

Here's how to address each point based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as new testing was not performed. The implicit acceptance criterion for this 510(k) was that the device must be "identical" to the predicate in all critical aspects.
   • Reported Device Performance: Not applicable; no new performance data was generated or reported for the Dynex Micro®.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable; no new test set or data was used for performance validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable; no ground truth establishment was required as no new performance validation was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable; no adjudication was needed as no new test set was evaluated.

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:

   • Not applicable. This is a bone fixation system, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

   • Not applicable. This is a medical device (external fixation system), not an algorithm.

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

   • Not applicable; no new ground truth was established for performance validation. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

   • Not applicable. This is a hardware device submission, not an AI/ML product requiring training data.

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

   • Not applicable.

In summary, the core of this 510(k) submission and its acceptance by the FDA rests on the principle of substantial equivalence, specifically due to the device being identical to its predicate except for the trade name. Therefore, the detailed performance testing and associated criteria typically seen for novel devices or those with material changes are not present in this document.

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