Search Results

1.5T Brivo MR355 and 1.5T Optima MR360 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 1.5T Brivo MR355 and 1.5T Optima MR360 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.

1.5T Brivo MR355 and 1.5T Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T Brivo MR355 and 1.5T Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document states, "Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission." However, a specific number for a "test set" (i.e., a dataset used for independent evaluation of the device's performance against ground truth) is not provided. The term "internal scans" and "sample clinical images" suggest internal testing rather than a formal test set with defined sample size.
• Data Provenance: Not explicitly stated. The company is GE Healthcare, with a submitter address in Beijing, China, but the origin of the "internal scans" and "sample clinical images" is not specified. It's safe to assume it's retrospective data gathered for internal validation.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not described. This submission did not involve a formal clinical study with a test set requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted and is not mentioned.
• Effect Size: Not applicable.

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

• Standalone Study: No, this device is a Magnetic Resonance Imaging System, not an AI algorithm. Its performance is inherent to its hardware and software specifications for image acquisition, not for an independent diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For the "internal scans" for workflow and image quality, the ground truth would likely be based on technical specifications, image quality metrics, and potentially visual assessment by technical experts or radiologists comparing against established benchmarks or the predicate device's performance. There's no mention of expert consensus for diagnostic accuracy, pathology, or outcomes data in specific clinical scenarios.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is an MRI system, not an AI algorithm that requires a "training set" in the machine learning sense. The development and validation involved standard engineering processes, not machine learning model training.

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

• Ground Truth Establishment for Training Set: Not applicable, as there was no training set for an AI algorithm. The device's "ground truth" for its development would be based on engineering specifications, physical principles of MRI, and comparison to existing, cleared MRI systems.

Summary of the Study:

The submission explicitly states: "The subject of this premarket submission, 1.5T Brivo MR355 and 1.5T Optima MR360 did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission."

Therefore, the "study" proving the device meets acceptance criteria was primarily a non-clinical validation process (risk analysis, requirements, design reviews, module verification, system verification, performance testing, safety testing, simulated use testing) demonstrating compliance with voluntary standards and substantial equivalence to a predicate device (1.5T Brivo MR355 and 1.5T Optima MR360 K103330). The "acceptance criteria" were implied to be the device's ability to produce high-quality MRI images across various body parts, consistent with its intended use and comparable to the predicate device's performance, as verified through internal testing and compliance with relevant standards. No formal clinical efficacy or diagnostic accuracy studies involving patient outcomes or expert adjudication were conducted or deemed necessary for this 510(k) clearance.

Ask a specific question about this device

The Brivo MR355 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 Brivo MR355 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 modified Brivo MR355 adds (1) one dedicated coil: 4-ch Breast Array Coil: (2) two clinical applications: VIBRANT and 3D FIESTA-C. The coil and clinical applications are standard for predicate Optima MR360 (K103330). All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T Brivo MR355 features a superconducting magnet at 1:5 Tesla. The data acquisition system operating accommodates up to 8 independent receive channels in various increments, and multiple independent coil elements per channel The system uses a during a single acquisition series. 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 1.5T Brivo MR355 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The provided text focuses on the 510(k) Premarket Notification Submission for the GE 1.5T Brivo MR355 Magnetic Resonance Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document explicitly states:

"The subject of this premarket submission, GE 1.5T Brivo MR355, did not require clinical studies to support substantial equivalence."

Therefore, the submission does not contain information related to acceptance criteria or a study proving the device meets said criteria. The GE 1.5T Brivo MR355 achieved regulatory clearance based on demonstrating substantial equivalence to an existing predicate device (K103330, GE 1.5T Brivo MR355/Optima MR360) and compliance with medical standards through non-clinical tests (e.g., risk analysis, requirements reviews, design reviews, performance testing, safety testing, internal and external evaluation).

Because no clinical study was required or performed for this specific submission to demonstrate acceptance criteria, the following requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable as no such study was conducted.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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, as this is an MR imaging device, not an AI-assisted diagnostic tool in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Brivo MR355/ Optima MR360 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 Brivo MR355/ Optima MR360 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 Brivo MR355 / Optima MR360 is a new MR system that is similar in design to previous GE Healthcare 1.5T MR systems. All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T Brivo MR355 / Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 8 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 1.5T Brivo MR355 / Optima MR360 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The provided text is for a GE Brivo MR355/Optima MR360 510(k) Premarket Notification and does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving its performance against such criteria. The document is for a traditional Magnetic Resonance Diagnostic Device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set sample size, how training ground truth was established) are not applicable to the provided information.

However, I can extract the performance parameters that were tested for this device, which can be interpreted as its "acceptance criteria" in the context of it being a new MR system demonstrating substantial equivalence to predicate devices.

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

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

The document mentions "Clinical images collected by volunteer scanning," indicating a prospective collection method using volunteers. No specific numerical sample size (number of volunteers or images) is given, nor is the country of origin of the data specified.

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)

This information is not provided. The document states that the images, when "interpreted by a trained physician yield information that may assist in diagnosis," but it does not detail an expert review process for establishing ground truth as one might for an AI/ML study.

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

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not described. This document pertains to a new MR imaging system, not an AI/ML algorithm intended to assist human readers.

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

This concept is not applicable as the device is an MR scanner, not an AI/ML algorithm. The performance tests described (SNR, image uniformity, etc.) demonstrate the standalone performance of the MR system itself.

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

For the performance parameters, the "ground truth" implicitly refers to the physical measurements and standards (NEMA, IEC, ISO). For the clinical images, the statement "All images show that the system meets the indications for use" suggests an assessment against clinical expectations or previous interpretations, likely by trained physicians, but the specific type of ground truth (e.g., expert consensus on specific findings, pathology correlation) is not detailed.

8. The sample size for the training set

The concept of a "training set" is not applicable as this is a traditional MR imaging device, not an AI/ML model that undergoes a training phase.

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

Not applicable.

Ask a specific question about this device