Search Results

The EBI® XFIX® DFS® OptiROM® Elbow Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

1. Fracture dislocation with ligamentos instability.
2. Comminuted intra-articular fractures.
3. Post traumatic reconstruction for joint stiffness.

The System consists of external fixation components and implantable bone screws. The EBI XFIX DFS OptiROM Elbow Fixator 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 EBI XFIX DFS OptiROM Elbow Fixator is attached to the shanks of the bone screws. This submission is for the addition of distractor component, which allows for gradual movement used in rehabilitation. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

The provided document is a 510(k) Summary for a Special 510(k) Device Modification for the EBI® XFIX® DFS® OptiROM® Elbow Fixator. This type of submission is used when a modification to an existing, legally marketed device does not significantly alter its fundamental scientific technology or intended use.

Therefore, the document does not describe a new study to prove the device meets acceptance criteria in the way a new device would. Instead, it argues for substantial equivalence to existing predicate devices based on the lack of significant changes in technological characteristics, materials, and intended use.

Here's an analysis based on the provided text, highlighting that many of the requested items (like acceptance criteria, sample sizes, ground truth establishment, MRMC studies) are not applicable or not present in a 510(k) for a device modification of this nature:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable/Not Provided: This document is a 510(k) for a device modification, not a submission for a new device requiring detailed performance studies against specific acceptance criteria. The modification is for the addition of a distractor component to an already cleared external fixator. The argument is for "substantial equivalence" based on the absence of significant changes. There are no detailed performance metrics or acceptance criteria presented for the modified device in this document, as the FDA typically considers the original device's performance already established.

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

• Not Applicable/Not Provided: No "test set" in the context of a performance study (like clinical trials or benchmark testing) is mentioned or implied. The substantial equivalence argument relies on comparing the modified device's characteristics (materials, intended use, function) to the predicate device, not on new performance data from a specific test set.

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

• Not Applicable/Not Provided: Since there's no "test set" and no new performance study described, there's no mention of experts establishing ground truth. The evaluation is focused on regulatory comparison.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Provided: As no performance study with a test set is described, there is no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, not performed/not applicable: MRMC studies are typically for evaluating diagnostic or interpretive tools, often comparing human performance with and without AI assistance. This document describes a mechanical external fixation device. Such a study would not be relevant.

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

• No, not performed/not applicable: This is a mechanical device, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used:

• Not Applicable/Not Provided: There is no performance study that requires a "ground truth" to be established in the context of this 510(k) submission. For a medical device of this type, a "ground truth" might refer to pathological confirmation or patient outcomes if a clinical trial were conducted, but that's not described here.

8. The Sample Size for the Training Set:

• Not Applicable/Not Provided: This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable/Not Provided: As this is not an AI/ML device, there is no training set or ground truth for a training set.

Summary of Device and 510(k) Argument:

• Device: EBI® XFIX® DFS® OptiROM® Elbow Fixator
• Modification: Addition of a distractor component, allowing for gradual movement in rehabilitation.
• Reason for 510(k): Special 510(k) Device Modification, asserting substantial equivalence to the predicate device (EBI® XFIX® DFS® OptiROM® Elbow Fixator K981483, K992515, K020403).
• Key Argument for Substantial Equivalence:
  • The additional component is made from the same materials as existing components.
  • The intended use and fundamental scientific technology have not changed.
  • The modified device's applications (fracture dislocation with ligamentous instability, comminuted intra-articular fractures, post-traumatic reconstruction for joint stiffness) are the same as the predicate device.
  • Bone screw clamps are designed for fixation of the bar and bone screw, similar to the predicate.
  • The device is provided non-sterile, like the predicate.
• Conclusion: The submission concludes there are no significant differences, making it substantially equivalent in intended use, materials, and function. The FDA concurred with this assessment, permitting the device to be marketed.

Ask a specific question about this device