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The EBI X FIX™ DynaFix® Mini External Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis. fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

The EBI X FIX™ DynaFix® Mini External Fixation System consists of fixator components and bone screws. The fixator frame consists of fixator rails which are connected by a central component. The fixator frame attaches to the bone via bone screws which penetrate the patient's skin. The fixator frame secures to the shanks of the bone screws with bone screw clamps. The EBI X FIX™ DynaFix® Mini External Fixation System is capable of providing physicians with capability to lengthen. The EBI X FIX™ DynaFix® Mini External Fixation System frame components are composed of aluminum alloy, titanium alloy and stainless steel. The EBI X FIX™ DynaFix® Mini External Fixation System bone screws are made of 316L stainless steel.

This document describes a 510(k) summary for a medical device, the EBI X FIX™ DynaFix® Mini External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance testing. This is not a study involving AI, image analysis, or human readers, so many of the requested fields are not applicable.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated in terms of number of devices tested. It is implied that "Comparative testing" was performed on test articles of the EBI X FIX™ DynaFix® Mini External Fixation System and the Orthofix® Mini Fixator and Mini Lengthener.
• Data Provenance: Not explicitly stated. The testing was performed for EBI, a US-based company, suggesting the tests were likely conducted in the US, but this is not confirmed. The study is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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

• N/A. This is a mechanical device performance study, not a study involving expert assessment of images or clinical outcomes. The "ground truth" here is the physical performance as measured by engineering tests.

4. Adjudication method for the test set

• N/A. As above, this is a mechanical testing study. Results are based on physical measurements, not human judgment requiring adjudication.

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

• No. This document describes a 510(k) submission for an external fixation system, focusing on its mechanical equivalence to predicate devices. It does not involve AI, image analysis, or human readers.

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

• N/A. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

• Mechanical Performance Data: The "ground truth" is established through standardized engineering testing for static and fatigue strength, measured according to relevant national or international standards (though not explicitly cited, this is typical for device testing). The performance of the predicate device serves as the benchmark.

8. The sample size for the training set

• N/A. There is no "training set" as this is not an AI/machine learning study.

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

• N/A. There is no "training set" or corresponding ground truth establishment process for this type of device submission.

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