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G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, 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, the thoracic and the lumbosacral 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 (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in 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 K161973 – are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• A new Software version (EVO'17) including the following features:
  • o New software feature Q-Spine (Quantitative Spine)
  • o New software feature 3D Viewer
  • o The availability of the E-MRI viewer eXP, the software used as an extension on PC.

Esaote has decided to develop and release an upgrade for software EVO. The EVO'17 includes two new features Q-Spine and 3D Viewer. The function Q-Spine has been already cleared by FDA under the name OrthoCAD System via K120288. The function 3D Viewer has been already cleared by FDA under the name 3Viseon/Surgery via K072653. E-MRI viewer eXP, the software used as an extension on PC, is equivalent to E-MRI Brio Viewer, which is currently available on the G-Scan Brio MRI systems, cleared via K161973.

The provided 510(k) summary for the G-scan Brio device does not include any acceptance criteria or a study demonstrating the device meets such criteria related to its imaging performance or diagnostic accuracy.

Instead, this submission (K180592) focuses on a software upgrade for an already cleared MRI system (G-scan Brio K161973). The upgrades consist of new software features (Q-Spine, 3D Viewer, and E-MRI viewer eXP), which are stated to have been previously cleared under separate 510(k)s (K120288 and K072653) or are equivalent to existing functionalities.

Therefore, the submission relies on the substantial equivalence of these software modifications and the underlying MRI hardware to previously cleared devices.

Here's an analysis of the provided information based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No test set or clinical data is presented for this 510(k) submission. The document explicitly states: "No clinical tests are included within this submission." The submission relies on non-clinical testing (safety standards, software verification) and the substantial equivalence to previously cleared devices.

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

• Not applicable. No clinical test set was used in this submission.

4. Adjudication method for the test set

• Not applicable. No clinical test set was used in this submission.

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 MRMC study was done and no AI components are described beyond standard image processing features. The software features (Q-Spine, 3D Viewer) are presented as tools for display, analysis, and comparison, not as AI systems for diagnosis or reader assistance.

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

• Not applicable. The device is an MRI system, not a standalone algorithm. The software features are enhancements to the MRI system for image display and analysis, to be interpreted by a medical expert. Their performance is described as "equivalent" or relying on previous clearances, not as standalone algorithm performance.

7. The type of ground truth used

• Not applicable. No clinical data was used in this submission. For the non-clinical testing, conformance to safety standards is the "ground truth" for those specific aspects.

8. The sample size for the training set

• Not applicable. No training set data is presented for this submission as it's not an AI/ML device relying on such for its core function.

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

• Not applicable. No training set data is presented for this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which, in this case, are primarily related to safety standards and substantial equivalence) consists of non-clinical testing and referencing prior 510(k) clearances.

• Non-Clinical Testing: The manufacturer conducted non-clinical tests to demonstrate compliance with various international and national standards for medical electrical equipment, risk management, and software verification (e.g., IEC 60601-1, ISO 14971, ISO 62304, NEMA MS-1, NEMA MS-3). The submission states that the device "has been found to conform" to these standards.
• Substantial Equivalence Argument: The core of the "proof" for the G-scan Brio's updated software lies in the argument of substantial equivalence to predicate and reference devices.
  • The updated G-scan Brio (K180592) is compared to the cleared G-scan Brio K161973.
  • New software features Q-Spine and 3D Viewer are stated to have been "already cleared by FDA" under K120288 (OrthoCAD System) and K072653 (3Viseon/Surgery) respectively.
  • The E-MRI viewer eXP is considered "equivalent to E-MRI Brio Viewer," which is available on the G-Scan Brio MRI systems cleared via K161973.

Conclusion stated in the document: "The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards."

In essence, this 510(k) relies on regulatory precedent and adherence to recognized safety standards rather than a de novo clinical study with specific performance acceptance criteria for diagnostic capability.

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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 head, limbs, joints and spinal column. It is intended for imaging the head, 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, the lumbosacral 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 use of MR equipment, the images can provide diagnostically useful information.

S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, 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 foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.

S-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 use of MR equipment, the images can provide diagnostically useful information.

The change performed on the modified G-scan Brio, with respect to the cleared version - G-scan Brio K142421 - are due to the improvement of the system performance. This modification is for the introduction of the new Shoulder Coil 20 code 130000014 (already cleared with S-scan K161238), the Head Coil 16 code 13000100, and the head indication for use.

The change performed on the modified S-scan, with respect to the cleared version – S-scan K161238 – are due to the improvement of the system performance. This modification is the introduction of the new Head Coil 16 code 13000100 and the head indication for use.

The provided text describes a 510(k) premarket notification for the G-scan Brio and S-scan Magnetic Resonance (MR) systems. It confirms FDA clearance for these devices due to their substantial equivalence to legally marketed predicate devices.

However, the document does not contain information regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, details of multi-reader multi-case studies or standalone algorithm performance, or the specific type of ground truth used outside of general "diagnostically useful information."

The document primarily focuses on:

• Regulatory Clearance: Affirming that the devices are substantially equivalent to predicates.
• Device Description and Intended Use: Outlining what the MR systems image (head, limbs, joints, spinal column) and how they function.
• Technological Characteristics: Describing the changes made (new coils for shoulder and head imaging) and stating they do not alter the core technology.
• Non-Clinical Tests: Listing adherence to various safety and performance standards (e.g., IEC, ISO, NEMA).
• Clinical Tests (briefly mentioned): Stating that "sample clinical images and attestation from a U.S. Board-Certified Diagnostic Radiologist that the images are of good diagnostic quality were provided."

Therefore, it is not possible to provide the requested information in the format of acceptance criteria and proven device performance based on the provided document. The document states that the devices are "as safe, as effective, and performs as well as or better than the predicate" based on non-clinical testing and general attestations about image quality, but it does not quantify these claims or provide the specific details of a performance study as outlined in your request.

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G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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, the thoracic and the lumbosacral 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 use of MR equipment, the images can provide diagnostically useful information.

The changes performed to G-scan Brio, with respect to the cleared version – G-scan Brio K133490 – 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:

• A new Bilateral TMJ Coil
• Introduction of the DPA Lumbar spine coil n° 10 with a new extra-large flexible section
• Introduction of the thoracic spine section examination
• A new software version including the following features:
  • o Customization of Image Enhancement
  • o Overlay sending to PACS
  • o Isotropic 3D acquisition

The provided document is a 510(k) summary for the G-scan Brio, a Magnetic Resonance (MR) system. It describes modifications made to an already cleared device (K133490) to improve system performance.

Based on the content, the document explicitly states that "No clinical tests were performed." This means there is no study described within this document that demonstrates the device meets acceptance criteria through clinical performance.

Therefore, most of the requested information cannot be provided from this particular document.

Here's what can be inferred or stated based on the document:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The submission focuses on adherence to safety standards and technical characteristic equivalence.
• Reported Device Performance: No clinical performance metrics are reported as no clinical tests were performed. The device's "performance" is demonstrated through non-clinical testing for compliance with safety and performance standards.

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

• Not applicable, as no clinical tests were performed.

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, as no clinical tests were performed.

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

• Not applicable, as no clinical tests were performed.

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 MRMC study was done, as no clinical tests were performed. The device described is an MR system, not an AI-powered diagnostic tool.

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

• No standalone performance study was done, as no clinical tests were performed. The device is a diagnostic imaging system, designed to be interpreted by medical experts.

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

• Not applicable, as no clinical tests were performed.

8. The sample size for the training set

• Not applicable, as no clinical tests were performed.

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

• Not applicable, as no clinical tests were performed.

Summary of Non-Clinical Tests (as provided in the document):

The document details that the G-scan Brio was evaluated through non-clinical tests to demonstrate substantial equivalence to its predicate device. These tests focused on:

• Medical electrical equipment safety
• Risk management
• Software verification
• Image quality

The device was found to conform to the following medical device safety standards:

• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-2-33
• ISO 14971
• ISO 62304
• IEC 62366
• NEMA MS-1
• NEMA MS-3

The conclusion states that "The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices to applicable medical device safety and performance standards."

In essence, the device's acceptance criteria in this submission are met by demonstrating compliance with recognized safety and performance standards through non-clinical testing, rather than through a clinical performance study.

Ask a specific question about this device

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.

Ask a specific question about this device

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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