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The 1.5T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to produce 2D and 3D images.

The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

The GE 6-Channel Phased Array Flex Coil is a surface coil used for Magnetic Resonance Imaging. It is tuned to image proton nuclei in a receive-only configuration. It is comprised of 6 individual phased array coil elements, each utilizing an integrated preamplifier to improve image quality. This coil is a receive-only, multi-coil array optimized for high-resolution examinations. The coil enables multi-oblique slice imaging. The coil is indicated for use, on the order of a physician in conjunction with an MR scanner, as an accessory to produce 2D and 3D images.

The provided document pertains to a 510(k) Premarket Notification for the GE 6-Channel Phased Array Flex Coil. This device is an accessory for Magnetic Resonance Imaging (MRI) scanners and is not an AI/ML-powered device. Therefore, the typical acceptance criteria and study design for AI/ML devices, such as performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable here.

The document states that the GE 6-Channel Phased Array Flex Coil did not require clinical studies to support substantial equivalence (Page 3). This is a crucial point regarding the "study that proves the device meets the acceptance criteria." Instead, GE Healthcare asserted substantial equivalence to a predicate device (K042844) based on non-clinical tests and technological similarity.

Here's an analysis of what is available from the document in relation to your request, adapted for a non-AI/ML medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device submission, the "acceptance criteria" are related to safety and effectiveness, demonstrated through compliance with voluntary standards and non-clinical testing, rather than performance metrics like sensitivity or specificity.

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

• Test Set Sample Size: Not applicable. The device did not undergo a clinical test set in the traditional sense for performance evaluation against a specific ground truth.
• Data Provenance: Not applicable for a clinical test set. The submission focuses on non-clinical engineering and safety verification. The document mentions "clinical images from validation have been included in DICOM format in Section 20 of the submission" (Page 3), but this is not framed as a rigorous clinical "test set" for performance metrics and does not provide details on sample size or provenance.

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

• Not applicable as there was no clinical "test set" requiring ground truth establishment by external experts for performance evaluation. The "ground truth" for the non-clinical tests would be defined by engineering specifications and safety standards.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done, as this is a non-AI/ML accessory device and clinical studies were not required for its substantial equivalence determination (Page 3).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable, as this is a physical MRI coil accessory, not an algorithm.

7. Type of Ground Truth Used

• For the non-clinical studies and verification tests, the "ground truth" would be the engineering specifications, voluntary standards (e.g., for safety and performance of MRI coils), and established benchmarks for image quality. There is no mention of pathology or outcomes data as "ground truth" for this type of device submission.

8. Sample Size for the Training Set

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable, as this is not an AI/ML device requiring a training set.

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

The study proving the GE 6-Channel Phased Array Flex Coil meets acceptance criteria (for substantial equivalence) was non-clinical. The submission relied on a comparison to a predicate device (K042844) and a battery of engineering and safety tests.

The document explicitly states: "The subject of this premarket submission, GE 6-Channel Phased Array Flex Coil, did not require clinical studies to support substantial equivalence. However, clinical images from validation have been included in DICOM format in Section 20 of the submission." (Page 3).

The "acceptance criteria" were met by demonstrating:

• Compliance with voluntary standards.
• Completion of a robust development and testing process including risk analysis, requirements reviews, design reviews, and various levels of verification (unit, integration, performance, safety) and simulated use testing (validation).
• The device employs the same fundamental scientific technology as its predicate device, with modifications primarily to electrical components in the connector to allow compatibility with newer MR systems.

The FDA's letter (Page 5-7) confirms that based on the provided information, the device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This indicates that the non-clinical evidence provided was sufficient for the FDA's regulatory requirements for this type of device.

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The Discovery MR450 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 MR450 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 GE Discovery MR450 is a new MR system that is substantially equivalent to previously cleared 1.5T /3.0T 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 GE Discovery MR450 features a superconductina magnet operating at 1.5 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 (aradients) 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 GE Discovery MR450 is designed to conform to NEMA DICOM standards (Diaital Imagina and Communications in Medicine).

The provided text is a 510(k) Premarket Notification for the GE Discovery MR450. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study evaluating an AI/diagnostic algorithm's accuracy, sensitivity, or specificity.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. The "performance" section refers to technical specifications and compliance with standards rather than clinical performance metrics against a defined ground truth.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for a diagnostic performance study, nor does it report specific "device performance" in terms of clinical accuracy, sensitivity, or specificity in the context of disease detection or diagnosis.

The "Performance" section outlines parameters that have been measured and documented through testing to NEMA, IEC, or ISO standards, suggesting the acceptance criteria are adherence to these technical standards.

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

This information is not provided in the document. The document refers to testing "to NEMA, IEC or ISO standards" for technical parameters, not a clinical test set with patient data.

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

This information is not provided. The document does not describe a test set that would require expert-established ground truth in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not provided. An adjudication method is not applicable given the type of testing described.

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

No, an MRMC comparative effectiveness study was not done or described in this submission. The submission focuses on substantial equivalence based on technical specifications and indications for use, not on improving human reader performance with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

This document describes a medical imaging device (MRI scanner), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable to the type of technical performance testing described for an MRI scanner in this submission. The ground truth for parameters like "Signal-to-noise ratio" or "Geometric distortion" would be defined by the measurement standards themselves (e.g., specific phantoms and procedures).

8. The Sample Size for the Training Set

This information is not provided. The document describes an MRI system, not a device incorporating a machine learning or AI component that would have a "training set."

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

This information is not provided and is not applicable as there is no mention of a training set for a machine learning model.

Summary of the Study for Substantial Equivalence:

The "study" described in the 510(k) is a comparison to predicate devices and technical testing to established industry standards (NEMA, IEC, ISO). The document states:

• "As stated in the FDA document 'Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' the following parameters have been measured and documented through testing to NEMA, IEC or ISO standards..." (Section 3)

The parameters tested include:

• Performance: Signal-to-noise ratio (SNR), Geometric distortion, Image uniformity, Slice thickness, Spatial resolution
• Safety: Static field strength, Acoustic noise, dB/dt, RF heating (SAR), Biocompatibility

The conclusion is that the GE Discovery MR450 is substantially equivalent to the predicate GE 1.5T Signa® HDx MR System and GE Signa® MR750, based on similar indications for use, technical specifications, and compliance with relevant industry and safety standards. There is no mention of clinical accuracy or diagnostic performance studies involving patients or human readers.

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