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G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified G-scan device (G-scan Brio), with respect to the cleared version - G-scan K111803 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A new patient table that can be moved manually in the inner/outer direction of the gantry.
• 2. A new footboard and seat for vertical examinations.
• 3. A patient table extension.
• 4. A back support.
• 5. A new step for patient positioning.
• 6. A new control panel on the front of the magnet.
• 7. Upgrading of the hydraulic circuit.
• 8. Upgrading of the electronics.
• 9. 4-channels Lumbar spine coils N.17 and 18 introduction, cleared via K110802.
• 10. A new software release.

The G-scan Brio is a Magnetic Resonance (MR) system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical testing focused on engineering and performance standards, not a clinical study involving human subjects or patient data. Therefore, there is no "test set" in the sense of a dataset of patient images with associated ground truth for evaluating diagnostic accuracy or a similar clinical performance endpoint. The testing involved the device in a laboratory setting to verify its adherence to technical specifications and safety standards.

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

Not applicable. As explained above, this was a non-clinical engineering and performance study. There was no "ground truth" related to medical diagnoses established by experts for a test set of images. The "ground truth" was the technical specifications and standards (e.g., specific SNR values, distortion limits).

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

Not applicable. No human interpretation of images for diagnosis or "adjudication" was performed as part of this non-clinical performance data. The device's performance was measured against established technical standards.

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:

No, an MRMC comparative effectiveness study was not done. The G-scan Brio is an MRI hardware system, and the filing focuses on technical and safety performance, not the diagnostic performance of a read by a human expert with or without AI assistance. The document predates widespread AI integration in MR system hardware.

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

No, a standalone algorithm performance study was not done. The G-scan Brio is an MRI system that requires interpretation by a human expert. The "performance data" refers to the system's compliance with technical and safety standards, not the performance of an independent algorithm for diagnostic interpretation.

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

The "ground truth" for this performance data was primarily technical specifications and established industry standards (e.g., NEMA standards for SNR, geometric distortion, image uniformity, slice thickness). The verification involved confirming the physical and technical parameters of the device met these engineering and safety benchmarks.

8. The sample size for the training set:

Not applicable. This document describes the performance of an MR imaging system (hardware and associated software), not an AI algorithm that requires a training set.

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

Not applicable. As this is not an AI algorithm, there was no training set or associated ground truth establishment process for a training set.

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