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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Specific Acceptance Criteria (Method/Standard)	Reported Device Performance
Mechanical Performance (Line Additions)	Substantially Equivalent to predicate devices based on ASTM F1541-02 (2011) e1 Standard Specification and Test Methods for External Fixation Devices and FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices.	Static axial & torsional grip strength testing and rigidity analyses confirmed that the line additions (new clamps and half pin for Large System, new clamps and carbon fiber bars for Small System) are substantially equivalent to the predicate devices.
MRI Conditional Status (XtraFix Large System w/ Carbon Fiber Bars - 3T MRI)	Magnetic Force: Force generated for device components in 3T MRI is less than the force on respective components due to gravity.	Force generated for device components in a 3T MRI is lesser than the force on the respective components due to gravity.
	Torque: Device components do not experience a measurable torque in a 3T static field.	The device components do not experience a measurable torque in a 3T static field.
	Heating (64 MHz): With worst-case construct 50cm from center of magnet, heating at most 4.5 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	Heating was at most 4.5 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Heating (128 MHz): With worst-case construct 50cm from center of magnet, heating at most 2.3 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	heating was at most 2.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Image Artifact: Largest image artifact did not extend more than 60mm from the device.	Largest image artifact did not extend more than 60mm from the device.
MRI Conditional Status (XtraFix Small System w/ Carbon Fiber Bars - 3T MRI)	Magnetic Force: Force generated for device components in 3T MRI is less than the force on respective components due to gravity.	Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity.
	Torque: Device components do not experience a measurable torque in a 3T static field.	The device components do not experience a measurable torque in a 3T static field.
	Heating (64 MHz): With worst-case construct 50cm from center of scanner bore, heating at most 1.3 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	Heating was at most 1.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Heating (128 MHz): With worst-case construct 50cm from center of scanner bore, heating at most 3 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	Heating was at most 3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Image Artifact: Largest image artifact did not extend more than 63mm from the device.	Largest image artifact did not extend more than 63mm from the device.

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.

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.
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.
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.
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.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
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."
The sample size for the training set: Not applicable. This is not a machine learning or AI-based device.
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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