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The EBI® DynaFix® Diaphyseal Correction 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® DynaFix® Diaphyseal Correction System is a module which is used in conjunction with the currently marketed EBI XFIX DFS System. The System consists of external fixation components and implantable bone screws. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the System is attached to the shanks of the bone screws.

This 510(k) submission for the EBI® DynaFix® Diaphyseal Correction System primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and testing results against those criteria. Therefore, most of the requested information regarding study details is not present in the provided text.

Based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria or report specific performance metrics for the device. The 510(k) relies on substantial equivalence to a predicate device.

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

Not applicable. No performance study data is presented.

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

Not applicable. No performance study requiring ground truth establishment is presented.

4. Adjudication method for the test set

Not applicable. No performance study data is presented.

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 device is a mechanical external fixation system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical external fixation system, not an AI algorithm.

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

Not applicable. No performance study requiring ground truth is presented.

8. The sample size for the training set

Not applicable. This device is a mechanical external fixation system, not a machine learning model.

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

Not applicable. This device is a mechanical external fixation system, not a machine learning model.

Summary of the Study and Acceptance Criteria (as per the provided text):

The provided 510(k) summary explains that the EBI® DynaFix® Diaphyseal Correction System is being marketed based on its substantial equivalence to a previously cleared device, the EBI® DynaFix® Diaphyseal Correction System (K021695).

The acceptance criteria for this type of submission are qualitative and focus on demonstrating that the new device has:

• Same intended use: The document explicitly states the intended use is "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," which is presumed to be the same as the predicate.
• Similar technological characteristics: The document states, "There are no significant differences between the EBI® DynaFix® Diaphyseal Correction System and other currently marketed external fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function."
• Similar materials: The components "may be manufactured from materials such as titanium, stainless steel, aluminum, and Delrin®," implying these are common and similar to the predicate.

The "study" that proves the device meets the acceptance criteria is the comparison of the new device to the predicate device, as presented in section 7 of the 510(k) summary. This is a comparative analysis based on a review of specifications and attributes, rather than a clinical trial or performance study with quantitative results. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This determination is the "proof" for the acceptance criteria in this context.

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The EBI® DynaFix® Diaphyseal Correction 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® DynaFix® Diaphyseal Correction System is a module which is used in conjunction with the currently marketed EBI XFIX DFS System. The EBI DynaFix Diaphyseal Correction System has not changed the Indications for Use or the fundamental scientific technology of the previously cleared System. The System consists of external fixation components and implantable bone screws. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue and into the bone. The fixator frame of the System is attached to the shanks of the bone screws.

The provided text describes the 510(k) summary for the EBI® DynaFix® Diaphyseal Correction System. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a study presenting performance data against acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it is generally not part of a 510(k) summary focused on demonstrating substantial equivalence.

Here's what can be inferred or directly stated from the provided text, and where information is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. For a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, which implies the new device performs as intended and is as safe and effective as the predicate.
• Reported Device Performance: The document states, "There are no significant differences between the EBI® DynaFix® Diaphyseal Correction System and other currently marketed external fixation systems. It is substantially equivalent to the predicate device in regards to intended use, materials, and function." This is a qualitative statement of equivalence rather than specific performance data against a set of quantitative criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable. This document does not describe a clinical or performance study with a test set.
• Data Provenance: Not applicable.

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 for a test set is described.

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

• Not applicable. No test set or adjudication process is described.

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 device is an external fixation system, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is not relevant to its regulatory submission.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. No ground truth for a study is mentioned. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

Summary of what is known from the provided text:

• Device Name: EBI® DynaFix® Diaphyseal Correction System
• Intended Use: 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.
• Regulatory Pathway: 510(k) Premarket Notification.
• Claim of Equivalence: The device is claimed to be substantially equivalent to the predicate device (EBI® XFIX® DFS® System K953406, K000319) in terms of intended use, materials, and function.
• Materials: Titanium, stainless steel, aluminum, and Delrin®.
• FDA Decision: FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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