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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 Brio, with respect to the cleared version - G-scan Brio K122006 - 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:

• PC Unit with GPU Card and LCD monitor NEC model P242W .
• A new Software version including the following features: .
  • 1. 3D acquisitions: SpeedUp technique
  • 2. 3D acquisitions: Elliptical filling of k-space technique
  • 3. Myelographic contrast technique
• A new operating system and database engine: .
  • 1. Operating system Microsoft Windows VISTA Ultimate 64 bit platform
  • 2. Database based on the built-in Microsoft SQL Server database Engine

The provided 510(k) summary for the G-scan Brio device does not include explicit acceptance criteria or a study demonstrating the device meets those criteria, as it is a Special 510(k) based on modifications to a previously cleared device (G-scan K122006).

Special 510(k)s are typically submitted when changes to a legally marketed device do not alter its intended use or fundamental scientific technology. The primary focus of such submissions is to demonstrate that the modified device remains as safe and effective as the predicate device, often relying on non-clinical testing.

Here's a breakdown of the requested information based on the provided document:

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

The document does not specify quantitative acceptance criteria in a table format or report specific device performance metrics in relation to such criteria. Instead, it states that the device has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification, and image quality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical tests were performed, and thus no test set of patient data was used. The evaluation primarily relied on non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical tests were performed, and therefore no ground truth was established by experts for a test set.

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

Not applicable. No clinical tests were performed, and thus no adjudication method was used for a test set.

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/CAD device. The device is a Magnetic Resonance (MR) system. No MRMC study was conducted.

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

Not applicable. This is not an AI/CAD device. The G-scan Brio is an MR imaging system.

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

Not applicable. Since no clinical tests were performed, no ground truth from patient data was established. The evaluation focused on non-clinical tests and conformance to safety standards.

8. The sample size for the training set

Not applicable. This is not an AI/CAD device, and no training set of data was used for algorithm development or machine learning.

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

Not applicable. As there was no training set, there was no ground truth established for one.

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