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The G-Beam™ Fusion Beaming System is intended to be inserted in the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions. It is indicated for fracture and osteotomy fixation, reconstruction procedures, non-unions and fusions of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus. Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).

Components and instrumentation included in the G-Beam™ Fusion Beaming System and the predicate device are both internal fracture fixation systems, as defined in 21 CFR 888.3040.

The provided text describes Orthofix Srl's G-Beam Fusion Beaming System and its 510(k) submission for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices through technical characteristics and mechanical performance testing rather than clinical studies or AI algorithm evaluation. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in the given text.

However, based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The text indicates that the device met or exceeded requirements established by test protocols and applicable standards. However, specific numerical acceptance criteria and precise performance values (e.g., specific load capacities, fatigue cycles) are not detailed in the provided summary.

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

The text refers to "mechanical testing" and "tests were performed" but does not specify the sample size of the devices or components used for these tests. Data provenance is not described in terms of country of origin or retrospective/prospective; it's related to laboratory testing results.

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

This information is not applicable as the device is a physical medical implant, not an AI-powered diagnostic device requiring expert interpretation of results for ground truth.

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

Not applicable, as this refers to adjudication of expert opinions for ground truth in diagnostic studies, which is not relevant for this device's evaluation.

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. The G-Beam Fusion Beaming System is a physical implant, not an AI system for image interpretation or diagnosis.

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

Not applicable. No AI algorithm is involved.

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

For mechanical testing, the "ground truth" is defined by the requirements of the standards (e.g., specific load magnitudes, displacement limits, fatigue life) within the scope of the testing protocols. For pyrogenicity, it's the absence of bacterial endotoxins as defined by the USP and ANSI/AAMI standards.

8. The sample size for the training set

Not applicable. There is no AI model requiring a training set.

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

Not applicable. There is no AI model requiring a training set or its associated ground truth establishment.

Summary of the Study performed (Mechanical and Pyrogenicity Testing):

Study Purpose: To demonstrate that the G-Beam Fusion Beaming System is substantially equivalent to legally marketed predicate devices in terms of mechanical performance and non-pyrogenicity.

Methodology:

• Mechanical Performance Testing:
  • Standards Used: ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices" and ASTM F-543-13 "Standard Specification and Test Methods for metallic bone screws".
  • Outcome: "A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure."
• Pyrogenicity Testing:
  • Standards Used: USP 38: 2014 "Bacterial endotoxin test (LAL)", USP 38: 2014 "Medical devices – bacterial endotoxin and pyrogen tests", and ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing".
  • Outcome: "tests were performed according to the following international standards" to establish non-pyrogenicity.

Results/Conclusion: All testing met or exceeded the requirements as established by the test protocols and applicable standards. The mechanical properties of the subject device were found to be "equivalent or better than the predicate device." The device was found to be "substantially equivalent to the predicate device" in terms of safety and effectiveness, and "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

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