Search Results

The EBI® XFIX® Vision® 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 System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision 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 EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the additional rod sizes to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

This is a 510(k) Premarket Notification for a medical device modification, not an AI/ML device. Therefore, the request for information on acceptance criteria and study details related to device performance in the context of an AI/ML system (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

The document describes a "Special 510(k) Device Modification" for the EBI® XFIX® Vision® Fixation System. This type of submission is typically for minor changes to an already legally marketed device where the modifications do not significantly alter the fundamental scientific technology or intended use.

Here's a breakdown of what the document does provide, structured to address relevant parts of your query, while explicitly stating where AI/ML-specific details are not present:

Acceptance Criteria and Study for K040833: EBI® XFIX® Vision® Fixation System

This submission is for a modification (additional rod sizes) to an existing external fixation system. The primary "acceptance criteria" and "study" for this type of submission revolve around demonstrating substantial equivalence to the predicate device, particularly regarding the modified components not raising new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

For a device modification of this nature, the "acceptance criteria" are implicitly met by demonstrating that the new components (additional rod sizes) do not change the fundamental characteristics, materials, or intended use compared to the predicate device. The "reported device performance" is a demonstration of this equivalency.

The following points (2-9) are typically relevant for AI/ML device submissions, but are NOT applicable to this 510(k) for a physical medical device modification. This document does not describe an AI/ML algorithm or its evaluation.

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

• Not Applicable. This is a physical device modification, not an AI/ML algorithm requiring a dataset for testing.

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

• Not Applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm for this submission.

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

• Not Applicable. No test set or adjudication process relevant to AI/ML performance 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 is not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. No algorithm is present.

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

• Not Applicable. No ground truth for an AI/ML task is relevant here.

8. The sample size for the training set:

• Not Applicable. No training set for an AI/ML algorithm is relevant here.

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

• Not Applicable. No training set or ground truth establishment for an AI/ML algorithm is relevant here.

Ask a specific question about this device

The EBI® XFIX® Vision® 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 System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision® Fixation 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 EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the modification of the SL Rapid Clamps and the addition of a 'MRI Safe' labeling claim to the existing System when the newly modified SL Rapid Clamps are utilized. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

The provided text describes a Special 510(k) Device Modification for the EBI® XFIX® Vision® Fixation System. This submission is for modifications to the SL Rapid Clamps and the addition of an 'MRI Safe' labeling claim. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K993886, K011711, K014194) based on unchanged intended use, materials, and fundamental scientific technology. The approval letter from the FDA confirms this substantial equivalence.

Therefore, I cannot provide the requested table and detailed study information as it is not present in the provided text. The document is a 510(k) summary for a device modification, which primarily focuses on demonstrating equivalence rather than presenting new clinical study data with performance metrics.

Ask a specific question about this device

The EBI® XFIX® Vision® 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 System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision® Fixation 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 EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the addition of "adapters" to the existing System, which allow connection to various EBI® XFIX® System Fixators. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

The provided text is a 510(k) summary for a medical device modification, specifically the EBI® XFIX® Vision® Fixation System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the safety and effectiveness of a novel device through clinical performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Here's why the requested information is absent and what the document does provide:

• Acceptance Criteria and Reported Device Performance: Not applicable for a 510(k) modification where substantial equivalence is claimed. The submission focuses on comparing the modified device's characteristics to a predicate device.
• Sample sizes for test set and data provenance: No test sets or clinical performance data are presented.
• Number of experts used to establish ground truth & qualifications: No ground truth establishment occurred as no performance study was conducted.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k).
• Standalone (algorithm only) performance: Not applicable as this is a mechanical fixation system, not an algorithm.
• Type of ground truth used: Not applicable as no performance study was conducted.
• Sample size for the training set: Not applicable as there is no algorithm or machine learning model in this device.
• How the ground truth for the training set was established: Not applicable.

What the document does discuss:

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence between a modified EBI® XFIX® Vision® Fixation System and its predicate devices (K993886, K011711). The modification involves the addition of "adapters" to the existing system.

The comparison focuses on:

• Materials: Stating that the additional components are fabricated from the same materials as the currently marketed system (Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy).
• Intended Use: Confirming that the modified device has the same indications for use as the predicate: "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."
• Function/Design: Highlighting that the bone screw clamps of the modified system are designed for attachment to the bone screws, similar to the currently marketed system.
• Sterility: Both are provided non-sterile.

The conclusion is that "There are no significant differences between the modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."

Ask a specific question about this device

The EBI® XFIX® Vision® 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 System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision® Fixation 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 EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the addition of "single locking" clamps to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

The provided text is a 510(k) Summary for a medical device modification (EBI® XFIX® Vision® Fixation System) and the FDA's clearance letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new AI/software device.

Therefore, the document does not contain the information required to populate the fields related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The document describes a modification to an existing external fixation system, specifically the addition of "single locking" clamps. The manufacturer asserts that the modified device is substantially equivalent to the predicate device in terms of intended use, materials, and function. This type of submission relies on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device performs similarly to the already cleared predicate.

No study proving the device meets acceptance criteria, as one would expect for an AI/software device, is described in this document. The basis for clearance is substantial equivalence to a predicate, not performance against specific metrics in a new study.

Ask a specific question about this device