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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 XtraFix Small External Fixation System subject of this 510(k) submission includes the following elements: Clamps (Bar/Pin to Bar/Pin, Integrated Multi-Pin); Bars; and Half Pins. The XtraFix Small External Fixation System is 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.

The provided document describes a 510(k) premarket notification for the Zimmer XtraFix® Small External Fixation System, which is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, studies, and ground truth establishment are not applicable.

The document discusses the substantial equivalence of the XtraFix® Small External Fixation System to previously cleared predicate devices based on technological characteristics and performance data.

Here's the relevant information based on the provided text, adapted for a medical device rather than an AI system:

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

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/ML system. Instead, it refers to non-clinical performance data obtained through characterization and evaluation.

• Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for MRI compatibility or mechanical strength). The evaluation was conducted on the "XtraFix Small External Fixation System," implying various components and configurations were subject to testing.
• Data Provenance: The tests were conducted according to established standards (ASTM F1541-02(2007)) and FDA guidance documents. This indicates laboratory testing and analysis, not data collected from human subjects (prospective or retrospective).

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

Not applicable. This is not an AI/ML device, and ground truth, in this context, is established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device. Performance is determined by meeting physical and material standards measured by equipment, not by human adjudication of results.

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/ML device. The study focused on the physical performance and safety characteristics of the device itself, not on human reader interpretation.

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

This refers to the performance of the device itself in a standalone capacity, as its function is mechanical/structural, not diagnostic or AI-driven. The "performance data (nonclinical)" presented (interconnection strength, system rigidity, MRI compatibility) reflects the intrinsic properties and behavior of the device without human interaction once installed or during the MR environment.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Engineering Standards and Specifications: Adherence to requirements outlined in ASTM F1541-02(2007) for external fixation devices.
• FDA Guidance Documents: Specific guidelines for orthopedic external fixation devices and establishing safety/compatibility of passive implants in MRI environments.
• Measured Physical Properties: Quantified measurements for force, torque, heating, and image artifact extension in MRI, compared against predefined safety thresholds.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that sense.

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

Not applicable. As there is no training set for an AI/ML system, this question is not relevant.

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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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