Search Results

The FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for:

-Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;

• Arthrodesis and osteotomies with associated soft tissue;

• Stabilization of non-unions; and

• Intraoperative temporary stabilization to assist with indirect reduction.

The systems consists of fixation half- pins attached to rigid clamps connected by adjustable telescoping tubes (bars) and are intended for use in the treatment of long bone fractures that require external fixation.

The provided text describes a 510(k) premarket notification for the FastFrame™ External Fixation System - Distal Radius. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with acceptance criteria in the context of AI/software performance.

Therefore, the information required to answer your specific questions about acceptance criteria, device performance, ground truth establishment, sample sizes, expert adjudication, and MRMC studies for an AI/software device is not present in this document. The document pertains to a physical medical device (an external fixation system) and its mechanical and physical performance.

Here's how the provided information relates to your questions, highlighting what is not available:

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

• Not available in the context of AI/software performance.
• The document mentions "Performance Evaluation – The mechanical testing confirmed that the subject device performs substantially equivalent in full construct rigidity and interconnection performance as compared to the predicate device." This refers to physical, mechanical properties (e.g., strength, stiffness), not diagnostic or AI performance metrics like sensitivity, specificity, or AUC.
• The device was found to be MRI Conditional, tested against ASTM standards (F2052-14, F2213-06, F2182-11a, F2119-07). These are physical safety and compatibility standards, not AI performance metrics.

2. Sample sizes used for the test set and the data provenance:

• Not applicable/Not available. This is a physical device; there is no "test set" of data in the sense of medical images or patient records for an AI algorithm. Mechanical testing would involve a certain number of physical units, but that's not the "sample size" you're asking about for AI validation.

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

• Not applicable/Not available. Ground truth as it relates to AI performance (e.g., disease presence in an image) is not relevant for this physical device.

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

• Not applicable/Not available.

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, an MRMC study was not done. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a physical external fixation system.

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

• No, this is a physical device, not an algorithm.

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

• Not applicable/Not available. The "ground truth" for a physical device like this relates to its material properties and mechanical performance, established by engineering tests and adherence to standards, not medical diagnostic labels.

8. The sample size for the training set:

• Not applicable/Not available. This is not an AI/ML device.

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

• Not applicable/Not available.

In summary: The provided 510(k) notification for the FastFrame™ External Fixation System - Distal Radius demonstrates substantial equivalence primarily through non-clinical performance data (mechanical testing). It explicitly states that "Clinical data and conclusions were not needed for these devices to show substantial equivalence." This type of submission does not involve acceptance criteria or studies related to AI/software performance, image analysis, or human reader assistance.

Ask a specific question about this device