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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 a carbon fiber ulnar bar, as well as components to allow for posterior bone screw placement in the humerus. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

This document pertains to a 510(k) submission for a device modification of the EBI® XFIX® DFS® OptiROM® Elbow Fixator. The submission focuses on the addition of specific components (carbon fiber ulnar bar and components for posterior bone screw placement in the humerus) and asserts that the intended use and fundamental scientific technology have not changed from the previously cleared submissions (K992515, K981483).

Therefore, this 510(k) notification represents a "Special 510(k) Device Modification" which primarily relies on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than requiring new clinical studies or detailed performance data against specific acceptance criteria for performance metrics typically seen with novel devices or significant design changes impacting clinical outcomes.

As such, the information you've asked for regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this specific regulatory submission.

Here's why and what information is available based on your request:

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

• Not Applicable. This Special 510(k) emphasizes substantial equivalence to a predicate device based on material changes (addition of carbon fiber) and minor design modifications (posterior bone screw placement components), without altering the fundamental technology or intended use. Performance acceptance criteria and reported device performance, in the sense of clinical effectiveness or safety metrics, are not typically required for such submissions when substantial equivalence is established through comparison to a legally marketed predicate. The "performance" being evaluated here is the device's continued conformity to the predicate's established safety and effectiveness.

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

• Not Applicable. No new clinical or performance test data (test set) is presented in this 510(k) summary for evaluation against specific metrics. The "test" here is the regulatory comparison to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. No clinical ground truth assessment by experts for new performance data was conducted or reported in this submission.

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

• Not Applicable. As no new clinical testing generating a test set requiring adjudication was performed or reported.

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 hardware device (external fixator), not an AI/software device. No MRMC study was conducted.

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

• Not Applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

• Not Applicable. Ground truth, in the clinical sense, is not relevant for this type of submission. 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, not an AI/machine learning device that would utilize a training set in that context.

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

• Not Applicable. See point 8.

Summary of the Regulatory Basis for this Submission:

• Device Type: Special 510(k) Device Modification for an External Fixation Device.
• Key Modification: Addition of a carbon fiber ulnar bar and components for posterior bone screw placement in the humerus.
• Claim for Substantial Equivalence: The submission asserts that the modified device is substantially equivalent to its predicate devices (EBI® XFIX® DFS® OptiROM® Elbow Fixator K981483, K992515) with regard to:
  • Intended Use: Remains the same (upper extremity treatment for bone/soft tissue conditions, including fracture dislocation, comminuted intra-articular fractures, and post-traumatic reconstruction for joint stiffness).
  • Materials: Same materials as predicate, with the addition of carbon fiber.
  • Function: Designed for fixation of bar and bone screw, similar to the predicate.
  • Sterility: Both are provided non-sterile.

The "study" in this context is the comparison of the technological characteristics of the modified device to the predicate device, as detailed in section 7 of the 510(k) Summary. The acceptance criterion for this type of submission is demonstrating that "there are no significant differences" between the modified device and the predicate device that would raise new questions of safety or effectiveness. The FDA's letter (K020403) confirms that they "have determined the device is substantially equivalent" to legally marketed predicate devices, thereby meeting this regulatory acceptance criterion.

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The EBI XFIX DFS® OptiROM™ Elbow Fixator external fixation device 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:
Fracture dislocation with ligamentos instability
Comminuted intra-articular fractures
Post traumatic reconstruction for joint stiffness

The EBI XFIX DFS OptiROM Elbow Fixator has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. 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 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.

The provided 510(k) summary does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of medical devices like AI algorithms or diagnostic tools. This 510(k) is for a mechanical external fixation device, not a software or AI-driven diagnostic product.

Here's a breakdown of why this information is absent and what the document does provide:

• Type of Device: The EBI XFIX DFS® OptiROM™ Elbow Fixator is a mechanical external fixation device used for stabilizing bones in the upper extremity. Such devices are typically evaluated based on their mechanical properties (e.g., strength, durability, biocompatibility of materials), design similarity to predicate devices, and manufacturing processes, rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
• 510(k) Process: For this type of device, the 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves comparing design, materials, intended use, and fundamental scientific technology. Clinical studies demonstrating diagnostic performance or reader improvement are generally not required for this type of submission unless there are significant technological differences or new safety/effectiveness concerns.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this specific submission.

What the document does indicate regarding "device performance" (in the context of substantial equivalence):

The document argues for substantial equivalence by stating:

• "The EBI XFIX DFS OptiROM™ Elbow Fixator is substantially equivalent to the following predicate EBI and competitive devices."
• "The components of the EBI XFIX DFS OptiROM Elbow Fixator are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS Joint Fixator."
• "The bone screw clamps... are designed for attachment to the bone screws," similar to the predicate.
• "The Distractor... is designed to provide the surgeon the ability to compress or distract the bone of the patient for optimal treatment," similar to the predicate.
• "It is substantially equivalent to the predicate devices in regards to intended use, materials and function."

In essence, the "proof" that this device meets acceptance criteria is its demonstration of substantial equivalence in design, materials, and function to previously cleared devices. There is no mention of a formal study with statistical endpoints to demonstrate improvement in human performance or standalone diagnostic accuracy because the device's function does not involve diagnostic interpretation.

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