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The Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation.

The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for temporary stabilization of tibial fractures in trauma procedures (damage control orthopaedics prior to definitive treatment). The product is indicated for non-weight- bearing use. The indications for use include:

• Tibial fractures extending from about 8cm below the knee to about 7 cm above the ankle joint, including comminuted open or closed tibial fractures and polytrauma.

• Temporary stabilisation of the tibia after debridement for osteomyelitis or an infected non-union pending second stage treatment.

The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit consists of a series of UNYCO Screws, UNYCO Cancellous Screws, Large Multiscrew Clamp for UNYCO Screws, Rods Ø12mm L 350mm and specific application tools. External fixation systems are modular, therefore different frame configurations are possible. The Orthofix components in the Galaxy UNYCO Diaphyseal Tibia Kit are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. The System is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation. The System may be used in conjunction with the Orthofix Galaxy Fixation system for crossing the knee and the ankle during temporary fixation.

The provided text is a 510(k) Premarket Notification for a medical device called the "Orthofix Galaxy UNYCO Diaphyseal Tibia Kit". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria in the context of an AI/software device performance study.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory document.

However, I can extract the information that is relevant to the device's performance demonstration.

Here's a summary of what can be inferred from the document:

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

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

• Sample Size: Not specified for the mechanical or MRI compatibility testing. The document states "components" were tested, implying physical samples of the device.
• Data Provenance: The tests conducted are laboratory-based mechanical and MRI compatibility tests on the device itself, rather than patient data.

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

• Not applicable. This is a physical device performance study, not a study evaluating human expert interpretation against a ground truth.

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

• Not applicable.

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 physical device, not an AI or software device.

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

• Not applicable. This is a physical device.

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

• For mechanical testing, the "ground truth" or reference was the performance requirements outlined in ASTM F 1541-02 and the performance of the predicate devices.
• For MRI compatibility, the "ground truth" or reference was the performance requirements outlined in ASTM F2182.

8. The sample size for the training set:

• Not applicable. This is a physical device.

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

• Not applicable. This is a physical device.

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