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The 18ch T/R Knee Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

The 18ch T/R Knee Coil is a transmit/receive. 18-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3T MR systems. The 18ch T/R Knee Coil is intended to be used for imaging the knee.

The 18ch T/R Knee Coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.

The 18ch T/R Knee Coil also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.

The provided text is a 510(k) Summary for a medical device called the "18ch T/R Knee Coil," a transmit/receive, 18-channel phased array coil designed for magnetic resonance imaging (MRI) of the knee. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for AI/software devices.

Therefore, many of the requested points related to acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission for a hardware device like an MRI coil.

However, I can extract the relevant performance data and conclusions regarding the substantial equivalence to the predicate device.

Here's a breakdown of the information that can be extracted and where the requested information is not applicable:

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

For an MRI coil, "acceptance criteria" are typically related to fundamental safety and performance standards rather than diagnostic accuracy metrics. The document references compliance with these standards.

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

This information is not applicable for the type of device and study described. This document pertains to the regulatory clearance of an MRI hardware component based on engineering and bench testing, not a clinical study involving patient data with a "test set" in the context of an algorithm or diagnostic accuracy.

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 applicable. Ground truth for diagnostic interpretation is not relevant for the engineering and safety testing of an MRI coil.

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

This information is not applicable. No adjudication method was used as there was no clinical test set requiring expert interpretation.

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

This information is not applicable. This device is an MRI coil, not an AI, CAD, or software device. No MRMC study was performed.

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

This information is not applicable. This is a hardware device, not an algorithm.

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

This information is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this device's performance is compliance with established engineering, electrical safety, and imaging standards (e.g., NEMA standards for SNR and uniformity).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device with a training set.

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

This information is not applicable. This is not an AI/ML device.

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The 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus and vasculature imaging. The nucleus excited is hydrogen.

The 3.0T GEM RT Open Array is a receive-only coil designed to provide optimal penetration, uniformity, and signal to noise ratio for the posterior head-neck and brachial plexus. The 3.0T GEM RT Open Array coil is an 8-Channel Phased Array, which is sold as an option to the Oncology Suite that is compatible with the 3.0T GE GEM compatible MR Scanner. The GEM RT Open Array is a posterior coil that comes with a Pconnector that can be plugged into the head end (P2) or foot end (P4) of the 3.0T GEM patient table (K103327). When used with the Oncology suite the GEM RT Open Array coil can be inserted into the GEM cradle at the head end.

This document describes the 510(k) premarket notification for the GE Healthcare 3.0T GEM RT Open Array coil, an RF coil designed for use with 3.0T MRI systems.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "The subject of this premarket submission, 3.0T GEM RT Open Array, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission."

Therefore, there isn't a "test set" in the traditional sense of a clinical study with a defined sample size for the device's performance in diagnosing conditions. The testing focused on technical compliance with electrical, EMC, and imaging quality standards. The sample clinical images mentioned are likely illustrative examples and not part of a formal performance evaluation with a statistical sample size. Data provenance is not specified beyond being "sample clinical images," likely from institutional data or internal testing, and it's retrospective as it's not a prospective clinical trial.

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

Not applicable. As no clinical studies were required, there was no ground truth established by experts for a test set to assess diagnostic performance. The ground truth was based on engineering and physics principles for compliance with technical standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

No. An MRMC comparative effectiveness study was not done as clinical studies were not required to support substantial equivalence. The device is a receive-only RF coil, focusing on image acquisition quality rather than diagnostic interpretation by human readers.

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

Yes, in essence. The "performance" assessment was primarily standalone, focusing on the coiled device's physical and electronic characteristics (electrical safety, EMC, SNR, uniformity) through non-clinical laboratory testing. There is no "algorithm" in the typical sense of AI, but the device's inherent imaging capabilities were evaluated independently against established standards.

7. The Type of Ground Truth Used

The ground truth for this device's acceptance was based on compliance with established engineering and safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS 6-2008). This is a technical ground truth, ensuring the device operates safely and produces images of expected quality based on physical parameters, rather than diagnostic outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component (an RF coil) and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this device.

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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.

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