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

The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. 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 problems;
• Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
• Stabilization of non-unions; and
• Intraoperative temporary stabilization tool to assist with indirect reduction.

The purpose of this traditional 510(k) is to seek clearance to market the line additions to the XtraFix Large and Small Systems. This traditional 510(k) also covers the proposed change to add a MRI conditional symbol on the existing carbon fiber bars in the XtraFix Large System so that the XtraFix Large System constructs with carbon fiber bars can be used in the MR environment (entirely outside the bore of the MRI scanner).

A Bar to Pin, 2D, independent locking clamp and a half pin are being added to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D, independent locking clamp and carbon fiber bars are being added to the XtraFix Small System. The XtraFix Large and Small Systems include the following elements: clamps, bars and half pins. The XtraFix Large and Small Systems are designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.

This document is a 510(k) summary for the Zimmer XtraFix External Fixation System and XtraFix Small External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices and establishing MRI conditional status for specific components, rather than providing a study on the effectiveness of a diagnostic or AI-based device. Therefore, a direct answer to the acceptance criteria and study proving device meets acceptance criteria in the requested format for AI/diagnostic devices is not applicable.

However, I can extract information related to the performance testing and acceptance criteria as provided for this external fixation system in the context of its regulatory clearance.

Acceptance Criteria for the XtraFix External Fixation System (Non-Clinical Performance)

The relevant "acceptance criteria" and "device performance" in this context are derived from non-clinical performance data, primarily demonstrating mechanical and MRI-compatibility characteristics.

Information Relevant to Study Details (within the context of this 510(k) submission):

This document describes a 510(k) submission for line additions and MRI conditional claims for an existing medical device, not a diagnostic or AI study. Therefore, many of the requested details for AI/diagnostic studies are not applicable.

1. Sample size used for the test set and the data provenance:

   • Mechanical Testing: Not specified as a "sample size" in terms of patient data. It refers to "line additions" (new device components) that underwent testing. The context implies mechanical testing was performed on representative units of these new components.
   • MRI Testing: The tests were conducted on "worst-case constructs" of the XtraFix Large System and XtraFix Small System with carbon fiber bars. The sample size for these physical tests would likely be a small number of physical prototypes or manufactured units rather than patient data.
   • Data Provenance: The tests are non-clinical, performed in a laboratory setting (implied). No country of origin for patient data is relevant.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and MRI conditional testing is established by engineering standards and physical measurements, not expert consensus on medical images or pathology.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human interpretation or adjudication.

4. 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 for fracture fixation, not an AI or diagnostic imaging device.

5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.

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

   • Mechanical Testing: Ground truth is based on engineering specifications, physical properties, and comparative performance against predicate devices as defined by standards like ASTM F1541-02 (2011) e1.
   • MRI Testing: Ground truth is based on physical measurements of magnetic force, torque, temperature change, and image artifact size as per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."

7. The sample size for the training set: Not applicable. This is not a machine learning or AI-based device.

8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device submission.

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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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