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The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Arthrodesis and osteotomies with associated soft tissue problems; o
• Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
• Stabilization of non-unions; and 0
• Intraoperative temporary stabilization tool to assist with indirect reduction. 0

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.

The provided document describes the 510(k) summary for the XtraFix External Fixation System Line Additions, focusing on its substantial equivalence to predicate devices rather than a de novo study with acceptance criteria and performance data. Therefore, many of the requested sections regarding user studies, ground truth, and sample sizes for AI/algorithm performance cannot be extracted directly from this document.

However, based on the information provided, here's what can be stated:

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

Since this is a 510(k) submission for line additions to an existing device, the acceptance criteria are primarily defined by "substantial equivalence" to predicate devices and adherence to relevant industry standards. The performance is demonstrated through mechanical testing.

Regarding the remaining questions, the provided 510(k) summary does not contain information about:

• 2. Sample size used for the test set and the data provenance: This document describes mechanical and MR compatibility testing, not clinical or AI/algorithm performance studies with test sets of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical images/data requiring human interpretation for ground truth were part of this 510(k) submission's evidence.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical or MR compatibility testing.
• 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 medical device (external fixation system), not an AI algorithm for diagnostic assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical and MR testing, "ground truth" would be established by the physical properties measured against the standard specifications. This is not comparable to clinical ground truth.
• 8. The sample size for the training set: Not applicable. No AI/algorithm training set was used.
• 9. How the ground truth for the training set was established: Not applicable. No AI/algorithm training set was used.

Summary of what the document implies for the study:

The study referenced is not a clinical efficacy study involving patient data, but rather benchtop mechanical testing and MR compatibility testing. The primary method for demonstrating "device meets acceptance criteria" is via adherence to established ASTM standards and FDA guidance documents for external fixation devices and MR safety, coupled with successfully proving substantial equivalence to existing predicate devices.

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The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
• . Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Stabilization of fractures in the context of polytrauma; .
• Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; .
• Arthrodesis and osteotomies with associated soft tissue problems; .
• Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
• Neutralization of fractures stabilized with limited internal fixation; .
• . Stabilization of non-unions; and
• . Intraoperative temporary stabilization tool to assist with indirect reduction.

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

The provided document describes the XtraFix External Fixation System, a medical device for stabilizing bone fractures. It does not contain information about a study with acceptance criteria and device performance in the context of an AI/algorithm-driven device. The document is a 510(k) summary, which is typically a premarket notification for a medical device demonstrating substantial equivalence to a legally marketed predicate device.

Specifically, the document states:

• "The principles of operation of the XtraFix External Fixation System are the same as for the predicates."
• "The XtraFix External Fixation System was characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the device can be used in an MR environment under predetermined conditions. Therefore, the term "MR Conditional" can be used to describe the system in accordance with the guidance document."
• "All evaluations determined that the XtraFix External Fixation System is substantially equivalent to the predicate devices."

This indicates that the "study" conducted was primarily focused on demonstrating MR compatibility and confirming the device's technological characteristics are similar to existing predicate devices, rather than a performance study with acceptance criteria for an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot populate the requested table and information points as they pertain to AI/algorithm performance and ground truth, as that information is not present in the provided text. The device is a physical external fixation system, not a software-based AI device.

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