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The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal. coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect and SIGNA Artist systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems each feature a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect. SIGNA Artist systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The original description hasn't changed from predicate devices (K160618), other than reflecting the additional receive channels available.

The modifications to these systems include the MAGIC DWI and CardioMaps software features, delivered via the DV26 program. The proposed software features will be ported over to other GE Healthcare MR systems based on appropriate design controls and evaluation of the change in accordance with FDA's Guidance—Deciding When to Submit a 510(k) for a Change to an Existing Device.

This document describes the premarket notification (510(k)) for GE Medical Systems' SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Magnetic Resonance (MR) diagnostic devices. The submission focuses on the addition of MAGIC DWI (Diffusion-Weighted Imaging) and CardioMaps software features.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or performance metrics for the MAGIC DWI and CardioMaps software features in a table format. Instead, it indicates that testing was completed with "passing results per the pass/fail criteria defined in the test cases."

Implicit Acceptance Criteria (inferred from the document):

• Safety and Effectiveness: The primary acceptance criterion is that the modified software features (MAGIC DWI and CardioMaps) are "as safe and effective as the predicate" devices and do "not raise different questions of safety and effectiveness."
• Compliance with Standards: The software features must comply with voluntary standards: AAMI/ANSI 62304, AAMI/ANSI ES60601-1, and IEC 60601-2-33.
• Acceptable Performance: Phantom testing for both software features must demonstrate "acceptable performance."

Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for either the phantom testing or the clinical images. It generically refers to "phantom testing" and "sample clinical images."
• Data Provenance: Not explicitly stated. For phantom testing, it's typically controlled laboratory conditions. For clinical images, it's not mentioned whether they are retrospective or prospective, nor their country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide this information.
The summary states that images and/or spectra are interpreted by a "trained physician," but it doesn't detail the number or qualifications of experts involved in establishing ground truth for the specific performance evaluation of the new software features.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.
It states that "passing results per the pass/fail criteria defined in the test cases" were achieved for phantom testing. For clinical images, it mentions they are "interpreted by a trained physician," implying clinical judgment, but no formal adjudication process (like 2+1 or 3+1) is described for the evaluation presented in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that an MRMC comparative effectiveness study was performed.
The evaluation relies on compliance with standards, phantom testing, and presentation of sample clinical images to demonstrate "substantial equivalence" rather than a comparative effectiveness study measuring human reader improvement with AI assistance. The software features are enhancements to image acquisition and processing, not explicitly AI-assisted diagnostic tools in the context of comparative reading studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the software features (MAGIC DWI and CardioMaps) represent algorithm-only additions, the document emphasizes that the "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis."
The "phantom testing" and quality assurance measures (e.g., unit-level, integration, performance, safety testing) can be considered standalone evaluations of the algorithms' output quality and adherence to specifications. However, the ultimate "performance" in the diagnostic context is tied to physician interpretation. The regulatory focus here is on the system producing diagnostically useful images, not on an algorithm making a standalone diagnosis.

7. The Type of Ground Truth Used

• For Phantom Testing: The ground truth would typically be established by known physical properties or measurements of the phantom itself. The "pass/fail criteria" would be based on expected quantitative accuracy, image quality, or signal properties against these known values.
• For Clinical Images: The document mentions "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the effectiveness in a clinical setting is ultimately judged by expert clinical interpretation, but it does not specify a formal "ground truth" (e.g., pathology, surgical findings, long-term outcomes) used to validate the clinical utility of the specific new software features. It's more about demonstrating that the images produced can be interpreted by a physician to assist diagnosis.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is likely because the referenced software features are defined as modifications to existing MR systems, and while they involve algorithms, the summary doesn't describe them as machine learning models that require distinct "training sets" in the typical sense. The development process described (risk analysis, requirements reviews, design reviews, various levels of testing) is a standard software engineering approach.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for machine learning, information on how its ground truth was established is not applicable or provided in this document.

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The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems feature a superconducting magnet operating at 1.5 Tesla or 3.0 Telsa. The data acquisition system accommodates up to 32 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.

This Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and the Optima MR450w 1.5T systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Modification for which this Special 510(k) is being filed is a Training PC which was introduced in the DV25.1 program. This modification allows users to train new technologist, optimize protocols, and evaluate pulse sequence development in the off-line environment.

The provided text is a 510(k) summary for a GE Medical Systems device, the Discovery MR750, Discovery MR450, Discovery MR750w, and Optima MR450w MR systems. The submission is for a modification to the existing predicate devices, specifically the introduction of a "Training PC."

Therefore, the document does not contain information about a study proving the device meets acceptance criteria for its core diagnostic function. Instead, it focuses on demonstrating substantial equivalence for the new modification (the Training PC) to the predicate devices.

Here's a breakdown of the requested information based on the provided text, and where it is missing for a typical medical device performance study:

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

• Missing. The document does not describe specific acceptance criteria for diagnostic performance or reported performance metrics of the MRI system's imaging capabilities. The modification is for a "Training PC," and the "performance" described relates to compliance with standards and quality assurance processes for this feature.

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

• Missing. No clinical or image-based test set information is provided as the submission is not for a new diagnostic device but a modification (Training PC).

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)

• Missing. No information on experts or ground truth establishment is provided as there is no diagnostic image test set described.

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

• Missing. No information on adjudication is provided.

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

• Missing. No MRMC study was done, as this submission is for a modification to an existing MRI system's training component, not a new AI-assisted diagnostic tool.

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

• Missing. Not applicable. This is not an algorithm-only device.

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

• Missing. No ground truth data is described.

8. The sample size for the training set

• Missing. No training set information is provided, as the submission concerns a "Training PC" (a computer for user training) and not an AI algorithm's training data.

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

• Missing. Not applicable.

Information Present in the Document (Related to the "Training PC" Modification):

The document states:

• Device Description (Modification): "Modification for which this Special 510(k) is being filed is a Training PC which was introduced in the DV25.1 program. This modification allows users to train new technologist, optimize protocols, and evaluate pulse sequence development in the off-line environment." (Page 4)
• Non-Clinical Tests: The system (with the Training PC addition) "complies with the NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance." (Page 5)
• Quality Assurance Measures applied to the development of the system with the addition of the new feature training PC:
  • Risk Analysis
  • Requirements Reviews
  • Design Reviews
  • Testing on unit level (Module verification)
  • Integration testing (System verification)
  • Simulated use testing (Validation) (Page 5)
• Clinical Tests: "The modification that prompted this submission did not require clinical testing." (Page 5)
• Conclusion: "GE Healthcare considers the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." (Page 5)

In summary, this document is a 510(k) for a minor modification (a training component) to an already cleared MRI system. It relies heavily on non-clinical testing showing compliance with standards and internal quality assurance processes to demonstrate substantial equivalence for the modification, rather than providing diagnostic performance data for the core MRI system or its "Training PC" feature.

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The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, coronal, and oblique images, spectroscopic images, parametric maps, and or spectra, dynamic images of the structures of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the Discovery MR750 3.0T, Discovery MR750w 3.0T and the Optima MR450w I.ST systems reflect the spaial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Discovery MR750 3.0T. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The Systems each feature a superconducting magnet. The data acquisition system accommodates up to 32 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.

The DV24 release is introducing new software features onto these existing MR Systems. There are also hardware modifications to the GEM configurations for Silenz compatibility. The Silenz feature used to reduce the acoustic noise generated during an MR examination is only available on the Optima MR450w GEM and Discovery MR750w GEM configurations.

The Discovery MR750 3.0T. Discovery MR450 1.5T. Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The GE Healthcare Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T Magnetic Resonance Diagnostic Devices did not undergo a study with specific acceptance criteria related to new AI features or performance metrics. This is because the submission (K132376) primarily focused on the introduction of new software features (DV24 release) and hardware modifications for Silenz compatibility on existing MR systems.

The submission states: "The subject of this premarket submission... did not require external clinical studies to support substantial equivalence." Instead, the focus was on demonstrating that the updated systems maintain the same imaging performance as their predicate devices.

Here's a breakdown of the information based on the provided document, addressing the requested points where applicable, and noting where the information is not provided because it pertains to an AI/performance study that was not conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for a dedicated test set against specific performance criteria. "Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features." The exact number of scans is not provided.
• Data Provenance: "Internal scans" suggests the data was generated within GE Healthcare. The country of origin and whether it was retrospective or prospective is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided. The study did not involve establishing a ground truth by experts in the context of a comparative performance study. The focus was on maintaining existing performance standards.

4. Adjudication Method for the Test Set

• Not applicable as a traditional adjudication method for a performance study was not described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not described or performed for this submission. The submission explicitly states, "The subject of this premarket submission... did not require external clinical studies to support substantial equivalence."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This submission relates to physical MR imaging devices and software updates, not a standalone AI algorithm with specific performance metrics.

7. The Type of Ground Truth Used

• No explicit "ground truth" as typically defined for AI performance studies was established. The "ground truth" was implicitly the existing imaging performance of the predicate devices. The internal validation aimed to ensure the new features did not degrade this established performance.

8. The Sample Size for the Training Set

• This information is not applicable. The document does not describe the development of a machine learning model with a separate training set. The "new software features" refer to changes in the MR system's operational software, not an AI algorithm trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there was no described training set for an AI algorithm.

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The Discovery MR750w 3.0T is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Discovery MR750w 3.0T features a superconducting magnet operating at 3.0 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750w 3.0T uses multi-drive RF transmit for imaging of the head and body regions. The Discovery MR750w 3.0T is designed to conform to NEMA DICOM standards.

The provided document is a 510(k) Premarket Notification Submission for a Magnetic Resonance Imaging (MRI) system, the GE Healthcare Discovery MR750w 3.0T. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about an AI/algorithm-based device and its performance against specific acceptance criteria in the manner requested.

Therefore, I cannot extract the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Key takeaway from the document regarding "acceptance criteria" and "study":

The document details the device's compliance with various voluntary standards (IEC and NEMA) and quality assurance measures applied during its development. It also states that non-clinical tests were conducted and summarized in verification testing, with passing results based on defined pass/fail criteria.

Crucially, under "Summary of Clinical Tests," it explicitly states:

"The subject of this premarket submission, Discovery MR750w 3.0T, did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality. The clinical results demonstrated that the Discovery MR750w 3.0T maintains the same imaging performance results as its predicate device, the Discovery MR750w 3.0T (K103327)."

This indicates that the device's enhanced features (specifically, multi-drive RF transmit for head scanning, which is a software change) were validated through internal non-clinical tests and internal scans for workflow and image quality, rather than formal clinical studies with a predefined set of acceptance criteria based on diagnostic performance that would typically be associated with AI/algorithm efficacy. The primary "acceptance criteria" here is demonstrated equivalence to the predicate device through these internal tests and compliance with recognized standards.

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The Discovery MR750w 3.0T is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The Discovery MR750w 3.0T features a superconducting magnet operating at 3.0 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The RF technology of the Discovery MR750w system integrates an RF transmit architecture designed to improve the overall image uniformity. This technology, called Multi-drive, optimizes RF transmit by adjusting the amplitude and phase of the RF output depending on the anatomy being scanned. In order to support Multi-Drive, the RF Transmit (Tx) chain is changed from MR750 and both Tx lines are divided into 2 lines with Dual output Exciter, Dual output RF amp, Dual Transmit/Receive Switch (DTRSW), dual UPM and a 70cm-wide patient bore RF body coil. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750w 3.0T is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Here's a breakdown of the requested information based on the provided 510(k) summary for the Discovery MR750w 3.0T.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Discovery MR750w 3.0T primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to established standards for safety and performance testing for Magnetic Resonance Imaging (MRI) systems. It does not provide specific numerical acceptance criteria with corresponding reported performance values in a direct table format. Instead, it states that various parameters "have been measured and documented through testing to NEMA, IEC or ISO standards" and that these tests were "executed with acceptable results."

Performance Parameters Tested:

Safety Parameters Tested:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific sample size for a "test set" in the context of clinical studies where individual cases are evaluated for device performance against a ground truth. Instead, it refers to "clinical images and clinical results summary" used to demonstrate imaging performance.

• Sample Size: Not explicitly stated. The summary refers to "clinical images and clinical results summary" but does not quantify the number of patients or images.
• Data Provenance: The manufacturing entity is GE Healthcare, (GE Healthcare Japan Corporation) and the contact person is in Japan. However, the document does not specify the country of origin of the clinical data (e.g., patient demographics, where the scans were acquired). It does not explicitly state whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not detail the process of establishing ground truth for a clinical test set in the way one might expect for an AI/CAD device. It states, "These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the interpretation by trained physicians (plural) constitutes the clinical reference standard or ground truth.

• Number of Experts: The document does not specify the number of experts. It generally refers to interpretation by "a trained physician" (singular in the Indications for Use, but "physicians" is implied for general clinical practice).
• Qualifications of Experts: The document only states "trained physician." No specific qualifications (e.g., specialty, years of experience) are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of detail is typically found in studies for AI-powered diagnostic devices, where disagreements among readers about ground truth or device performance are resolved. For this MRI system, the primary focus is on technical performance and equivalence to predicates, rather than a diagnostic performance study with specific adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or reported in this 510(k) summary. The document does not discuss human reader performance, with or without AI assistance. The summary's focus is on the device's technical performance and safety, and its substantial equivalence to predicate MRI systems.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Discovery MR750w 3.0T is a Magnetic Resonance Imaging System, not an algorithm or AI-powered diagnostic tool in the typical sense that would have "standalone performance" evaluated for diagnostic accuracy. It's a hardware system that generates images. Therefore, the concept of "standalone performance" as it applies to an algorithm without human-in-the-loop is not relevant here. The device's performance is inherently tied to the quality of the images it produces, which are then interpreted by a human physician.

7. The Type of Ground Truth Used

The ground truth for clinical evaluation is implicitly based on expert consensus/interpretation by trained physicians using the images produced by the device. The document states that "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This suggests the clinical utility is assessed through conventional medical diagnostic workflows. There is no mention of pathology, long-term outcomes data, or other objective ground truth methods.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this 510(k) submission. The Discovery MR750w 3.0T is an MRI system, a hardware device, not a machine learning or AI algorithm that requires a training set of data. Its design and performance are based on engineering principles, physics, and established medical imaging standards, rather than learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established

Since the device is an MRI system and not an AI algorithm, there is no "training set" or corresponding ground truth establishment process in the machine learning sense. The device's operational parameters and image quality are validated against physical phantoms, engineering specifications, and established industry standards (NEMA, IEC, ISO).

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