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The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as:

• comminuted open or closed fractures
• polytrauma patient
• damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• intra-operative fracture reduction
• intermediate stabilization in staged surgery
• infected non-union pending second stage treatment bone-loss or other reconstructive procedures.

The Galaxy UNYCO System consists of a series of sterile kits that include clamps, rods, screws and specific application tools. An external fixation system, as the subject device, is modular and so different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws.

Here's an analysis of the provided text regarding acceptance criteria and studies, organized as requested.

The provided document describes the Galaxy UNYCO System, which is an external fixation device. This device is exempt from the typical AI/machine learning evaluation criteria, as it is a mechanical device, not a diagnostic algorithm. Therefore, many of the requested fields (such as effect size of human readers with AI, standalone performance, training set details, and expert ground truth establishment for AI) are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, mechanical performance, and biocompatibility, as is typical for traditional 510(k) submissions for mechanical devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Galaxy UNYCO System are based on its mechanical performance and biocompatibility, demonstrating that it meets established standards for external skeletal fixation devices and medical-grade materials. The reported performance indicates that the device met or exceeded these requirements.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Focusing on Mechanical Device Evaluation)

As this is a mechanical device, the "study" primarily refers to bench testing and material characterization, not clinical trials or AI performance evaluations.

• Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "sample size" for a test set as would be for an AI model. The evaluation involved mechanical testing of device components and biocompatibility testing of materials. The data provenance would be laboratory testing conducted by or for Orthofix Srl. No specific country of origin for this testing data is provided, but Orthofix Srl is located in Italy.
• 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 devices is established through engineering specifications, material science, and established international standards (e.g., ASTM, ISO), not by expert consensus in diagnosing cases.
• Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, common in diagnostic imaging studies for AI.
• 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 device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
• The type of ground truth used:
  • Mechanical: Engineering specifications and performance defined by international standards (ASTM F1541-02e1, ASTM F899-12b, ASTM F543-13e1).
  • Biocompatibility: Standards for non-pyrogenicity and material safety (USP 38:2014, ANSI/AAMI ST72:2011).
• The sample size for the training set: Not applicable. This is not an AI device and does not have a "training set" in the machine learning sense. The design and material choices are based on established engineering principles and prior knowledge.
• How the ground truth for the training set was established: Not applicable.

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The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

Temporary stabilization of the tibia and foot in conditions and procedures, such as:

• · comminuted open or closed tibial fractures
• · polytrauma patient
• · damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• · joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• · intra-operative fracture reduction
• · intermediate stabilization in staged surgery
• · infected non-union pending second stage treatment bone-loss or other reconstructive procedures

The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not indicated or available. The product is indicated for non-weight-bearing use.

The Orthofix Galaxy UNYCO System consists of a series of sterile kits that include UNYCO Cancellous Screws, Large Multiscrew Clamps for UNYCO Screws, Rods Ø 12mm, a radiolucent Foot Unit and specific application tools. External fixation systems are modular, therefore different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing.

Acceptance Criteria and Device Performance for Galaxy UNYCO System (K153233)

The provided documentation describes the acceptance criteria and study findings for the Orthofix Galaxy UNYCO System, a device intended for temporary bone stabilization.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document primarily relies on mechanical testing and material comparison for demonstrating substantial equivalence. It does not mention a "test set" in the context of clinical data or patient data.

• Test Set (for mechanical and MRI testing): The specific number of devices/components tested for mechanical performance (ASTM F 1541) and MRI compatibility (ASTM F2182) is not explicitly stated in the provided summary.
• Data Provenance: The studies are described as non-clinical technical assessments (mechanical and MRI compatibility testing) rather than clinical studies with patient data. Therefore, there is no mention of country of origin or retrospective/prospective nature regarding patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the studies were non-clinical mechanical and MRI compatibility tests. Ground truth in this context would be defined by the technical specifications of the standards (ASTM F 1541, ASTM F2182).

4. Adjudication Method for the Test Set:

This information is not applicable as the studies were non-clinical mechanical and MRI compatibility tests. Adjudication methods are typically associated with human reviewer assessments in clinical or diagnostic studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

6. Standalone Performance (Algorithm Only):

No standalone performance study for an algorithm was mentioned. The device is a physical external fixation system, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the evaluation of the Galaxy UNYCO System was based on:

• Engineering Standards: Specifically, the requirements and methodologies outlined in ASTM F 1541 for mechanical performance and ASTM F2182 for MRI compatibility.
• Predicate Device Characteristics: Comparison to the established design, materials, and mechanical performance of legally marketed predicate devices (Synthes Large External Fixation, MR Conditional (K082650) and Orthofix Galaxy Unyco Diaphyseal Tibia Kit (K142052)).

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated in point 8.

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