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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.

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 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.

Ask a specific question about this device

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.

Ask a specific question about this device

G-scan 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 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.

G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K110238 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. Temporomandibular receiving coil.
• 2. New sensor for magnet patient table system rotation.
• 3. Import/export, in DICOM format, images/patient data on USB pen drive.
• 4. Streaming acquisition.
• 5. Modified pulse sequences.
• 6. A new software release.

This 510(k) summary for the Esaote G-Scan MR system (K111803) indicates that it is a modification of a previously cleared device (K110238). This type of submission, often a Special 510(k), focuses on demonstrating that the modified device is as safe and effective as the predicate device, not necessarily on a novel clinical performance study for diagnosing conditions.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for diagnostic accuracy. Instead, it focuses on demonstrating that modifications to the device (new coil, sensor, DICOM export, streaming acquisition, pulse sequences, and software) do not alter the fundamental scientific technology or intended use and that non-clinical testing confirmed it meets performance requirements and is as safe and effective as the predicate.

Here's a breakdown of why many of your requested points cannot be extracted from this document, and what is mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated for diagnostic performance in this document. The focus is on demonstrating that the modified device "met performance requirements" generally, implying equivalence to the predicate.
• Reported Device Performance: No specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported. The document states that "non-clinical testing... demonstrated that it met performance requirements and is as safe and effective as the predicate device."

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

• Not Applicable/Not Provided: This document describes a Special 510(k) for device modifications, not a new clinical performance study for diagnostic accuracy. No information on a test set (e.g., patient cases used for diagnostic evaluation) is present.

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

• Not Applicable/Not Provided: As no diagnostic performance study involving a test set is described, there's no mention of experts establishing ground truth for such a set.

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

• Not Applicable/Not Provided: For the same reasons as above.

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: This document is for an MR system, not an AI-powered diagnostic tool. No MRMC study is mentioned, nor is any AI component.

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

• Not Applicable/No: This is a diagnostic imaging device, not an algorithm. Standalone performance as you describe is not relevant here.

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

• Not Applicable/Not Provided: No diagnostic performance study is described. The "ground truth" for the non-clinical testing referenced would likely relate to engineering specifications, image quality metrics, and safety standards, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

• Not Applicable/Not Provided: No machine learning or AI component is mentioned, so there is no training set for an algorithm.

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

• Not Applicable/Not Provided: For the same reasons as above.

Summary of what the document does state about performance:

• Type of Study: Non-clinical testing.
• Purpose: To demonstrate that the modified G-scan system met performance requirements and is as safe and effective as the predicate device (K110238).
• Nature of Performance: Related to the improvements in system safety and performance due to the specific modifications listed (e.g., new coil, software, pulse sequences). This would likely involve technical image quality assessments, safety checks, and functional tests to ensure the device operates as intended and produces diagnostically useful images when interpreted by a medical expert.
• Intended Use: The device produces images of internal structures (limbs, joints, spinal column) that, when interpreted by a medical expert trained in the use of MR equipment, can provide diagnostically useful information. This emphasizes the human-in-the-loop nature of its use.

Ask a specific question about this device

G-scan 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 and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

G-scan 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.

G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K042236 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A modified version of the magnet poles and of the gradient coils.
• 2. New receiving coils.
• 3. Modified pulse sequences.
• 4. A new Emergency button procedure.
• 5. A new safety device named sensitive edge.
• 6. A new safety switch named "Bed in"
• 7. A hand protection for patient table.
• 8. A head protection for patient table.
• 9. An exam positioning indicator kit for patient table.
• 10. A new step for patient positioning.
• 11. Contraindications have been added in the user manual due to the possibility of patient syncope caused by protracted orthostatic positions required for the examination.
• 12. A new software release.

The provided 510(k) summary for the G-Scan MR system does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria. This summary focuses on demonstrating substantial equivalence to a predicate device based on modifications to an existing and cleared MR system.

Here's why and what information is missing:

• Focus on Substantial Equivalence: The document is a 510(k) summary, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, rather than presenting de novo performance studies against specific acceptance criteria.
• Modifications, Not New Device: The G-Scan discussed is a modified version of an already cleared device (G-scan K042236). The modifications listed (magnet poles, coils, pulse sequences, safety features, software) are presented as improvements to safety and performance that "do not affect the intended use or alter the fundamental scientific technology of the device." This context suggests that extensive new performance studies (like those for a novel AI device) against acceptance criteria were likely not deemed necessary for this type of submission.
• Interpretation by Medical Expert: The "Indications for Use" section states: "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This implies that the diagnostic performance is ultimately dependent on a human expert, not solely on an algorithmic output against predefined metrics.

Therefore, I cannot provide the requested table and details as they are not present in the provided text. The document is concerned with the safety and technological equivalence of an updated magnetic resonance imaging system, not the analytical or clinical performance of an AI algorithm against specific acceptance criteria.

Ask a specific question about this device

S-scan 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 and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-scan 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 indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
• 2. A limb protection for patient table.
• 3. Modified pulse sequences.
• 4. A new software release.

The provided text is a 510(k) summary for the S-scan System, a Magnetic Resonance Imaging (MRI) device. It details modifications to an existing device (K063207) and compares its technological characteristics to several predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

The submission focuses on establishing substantial equivalence to previously cleared devices based on technological characteristics and intended use, rather than presenting new performance study data for approval. Therefore, I cannot complete the requested tables and information based on the input provided.

Here's a breakdown of what is present in the document, and what is not:

What is present:

• Device Name: S-scan System, Nuclear Magnetic Resonance Imaging
• Intended Use: Produces transversal, sagittal, coronal, and oblique cross-section images of limbs, joints, and the spinal column for diagnostic information when interpreted by a medical expert.
• Predicate Devices: S-scan (K063207), G-scan (K042236), Siemens Magnetom C! (K043030), Esaote Dynamic MRI Software (K061429), Siemens Syngo Multimodality Workstation (K010938).
• Modifications to the S-scan (K063207):
  • Device that locks the patient table.
  • Limb protection for the patient table.
  • Modified pulse sequences.
  • A new software release.
• Technological Characteristics Comparison: Detailed lists of pulse sequences and their parameters for the modified S-scan compared to the predicate S-scan (K063207), G-scan (K042236), and Siemens Magnetom C! (K043030). Also details image processing functions, networking functions, system access management, and accessories compared to predicate devices.

What is NOT present (and therefore cannot be provided in the requested format):

• Table of Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are stated. The submission relies on demonstrating substantial equivalence to predicates, implying that if the technological characteristics and intended use are similar, the performance is also considered similar.
• Study details (Sample size, data provenance, number of experts, adjudication method, MRMC, standalone performance, ground truth type, training set size, ground truth for training set): The document does not describe any specific performance study conducted to assess the diagnostic accuracy or clinical effectiveness of the modified S-scan device. The "study" here is essentially a technical comparison for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating that the modified S-scan device is substantially equivalent to existing cleared devices based on its technological characteristics and intended use, rather than providing the results of a clinical performance study with specific acceptance criteria.

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E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan Opera MR 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 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 system is composed of these main parts:

1. Patient positioning table.
2. Magnetic unit with the display panel.
3. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
4. Electronics box with filter panel.
5. Modular shielding box.

This 510(k) summary (K060956) is for the E-scan Opera, a Magnetic Resonance (MR) diagnostic device. It's important to note that this submission is a Special 510(k), meaning it's for modifications to an already cleared device (E-scan XQ K032121), and the changes do not affect the intended use or alter the fundamental scientific technology of the device.

Therefore, the submission focuses on demonstrating that the modified device remains substantially equivalent to the predicate devices and does not introduce new questions of safety or effectiveness. This type of submission typically relies on a comparison of technological characteristics with predicate devices rather than new clinical performance studies with specific acceptance criteria in the same way a de novo device might.

Based on the provided document, the acceptance criteria and study information typically sought for a new or significantly modified device's performance are not explicitly present or detailed because this is a Special 510(k) for minor modifications to an existing technology. The "study" here is essentially the comparison of technical specifications and demonstrating that the changes do not negatively impact performance or safety.

Here's an attempt to answer your questions based on what's available and the nature of a Special 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For a Special 510(k) like this, specific "acceptance criteria" and "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not required or presented in the same way as for a new device. The "performance" is inherently demonstrated by showing substantial equivalence to the predicate device, which has already established acceptable clinical performance.

The document highlights the changes and compares the technical characteristics of the E-scan Opera to its predicate devices (E-scan XQ K032121 and G-scan K042236, as well as MAGNETOM Vision K945517 for software features). The "acceptance criteria" are implied to be that these changes do not degrade the performance or safety of the device compared to the predicate, and in some cases, improve user experience (e.g., lower patient table).

2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this type of submission. As a Special 510(k) for modifications that do not alter the fundamental scientific technology or intended use, a specific clinical "test set" with a defined sample size for performance evaluation (e.g., diagnostic accuracy) is not typically required or performed. The demonstration of substantial equivalence is based on engineering changes and comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new clinical performance study requiring expert-established ground truth was detailed in this submission. The device relies on existing MR technology where "medical expert trained in the use of MR equipment" interpret images.

4. Adjudication method for the test set
Not applicable/Not provided. No new clinical performance study requiring adjudication was detailed.

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 device is a basic MR imaging system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a basic MR imaging system, not an algorithm being evaluated for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For an MR imaging device, the "ground truth" for diagnostic purposes is typically pathology, surgical findings, or clinical follow-up as interpreted by human experts. However, no new clinical study requiring the establishment of ground truth for performance metrics was conducted or reported in this Special 510(k).

8. The sample size for the training set
Not applicable/Not provided. This submission does not involve a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable/Not provided. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.

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The G-scan Cervical Spine Coil is to be used in MR imaging of the cervical section of the spine column.

G-scan 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 and imaging portions of the spinal column, including the cervical, thoracic and lumbo-sacral sections.

G-scan 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 Cervical Spine Coil is to be used with the MRI system G-scan, cleared via K042236.

This is a solenoidal linear receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's cervical vertebrae; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.

The patient's neck is inserted into the coil after the coil itself has been opened by means of nonmagnetic contacts inserted in the coil loops.

The height of the patient's head can be regulated by a suitable mechanism with a lever command. A special cushion is attached to the coil assuring that the patient maintains comfortably his position during the examination.

The mechanical connection between the coil and the patient table is provided through a mechanism that positions the coil at the proper position for a cervical examination.

The coil is equipped with a connecting cable, which must be fitted to the connector on the patient table for proper electrical wiring and for automatic coil model recognition.

The coil resonator is composed of 3 copper tubes each one with two couples of non-magnetic contacts, the three tubes are arranged in a circular path and connected in series and with 3 tuning capacitors groups.

De-coupling between the transmitting and the receiving coil is accomplished via a couple of PIN diodes in a passive circuit. During the RF transmitting pulse, the diodes placed in the receiving coil decoupling circuit are switched on by the pulse and enable a LC parallel resonating circuit, at the working frequency, so that the overall impedance of the coil becomes very high and the parasitic current is minimised.

The provided text is a 510(k) summary for a medical device (G-scan Cervical Spine Coil) seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way a diagnostic AI device might.

Therefore, the document does not contain the kind of information typically found in a study proving a device meets acceptance criteria, especially for software-based diagnostic aids. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (beyond general similarity to predicate device).
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or specific standalone performance metrics.
• Details on ground truth establishment for training or test sets.

Instead, the document focuses on:

• Device Description: What the G-scan Cervical Spine Coil is, how it works, and its physical characteristics.
• Intended Use: The medical application for which the device is designed (MR imaging of the cervical spine column).
• Technological Characteristics Comparison: A side-by-side table comparing the new device's coil characteristics (primarily dimensions) to those of the predicate device. This is the closest the document comes to performance comparison, but it's a comparison of physical specs, not diagnostic accuracy.
• Substantial Equivalence Argument: The core of a 510(k) is to argue that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness.

Based on the provided text, I cannot fill out the requested table and answer many of the specific questions because the document does not contain that information. The G-scan Cervical Spine Coil is a physical component of an MRI system, not a diagnostic AI algorithm, and therefore its clearance process relies on demonstrating physical and functional similarity to an already cleared device, rather than a clinical trial demonstrating diagnostic performance against specific benchmarks.

If this were a submission for a diagnostic AI device, the information you requested would be critical. However, for a physically similar device like a new coil for an existing MRI system, the FDA's focus is on safety and effective integration with the existing system, and ensuring its technical parameters are comparable to predicate devices.

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