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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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The GEM RT Open Array Coil that is a part of the Oncology Suite is a receive-only RF coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

The 1.5T GEM RT Open Array is a receive only 8-Channel 8-element Posterior Phased Array, for use as an option to the Optima MR450w MR Systems with GEM suites. It is a posterior array which can be inserted into the GEM Table cradle (K103335) at either the head or foot end.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Healthcare 1.5T GEM RT Open Array:

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness. The submission is for a medical device that appears to be an RF coil for an MRI system, not an AI/ML powered device, hence most of the questions posed (e.g., effect size of human readers improving with AI, standalone performance, training set details) are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests related to safety and performance standards of the coil itself, rather than its diagnostic output.

However, based on the non-clinical tests described, we can infer some "acceptance criteria" related to the device's technical specifications and safety compliance.

Here's a breakdown of the requested information, adapted to what is actually available in the document:

Analysis of Acceptance Criteria and Proving Study for GE Healthcare 1.5T GEM RT Open Array

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

Since this is a submission for an MRI RF coil, not an AI/ML diagnostic device, the acceptance criteria are focused on safety, electromagnetic compatibility, and technical performance related to signal quality. The document states compliance with established standards.

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

• Sample Size: The document explicitly states: "The subject of this premarket submission, 1.5T GEM RT Open Array, did not require clinical studies to support substantial equivalence." Therefore, there is no formal "test set" in the context of clinical images or patient data for evaluating diagnostic performance. "Sample clinical images have been included in this submission," but these are not described as part of a formal test set with defined sample size for performance evaluation.
• Data Provenance: Not applicable as a formal clinical test set was not used.

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

• Not applicable as a formal clinical test set requiring expert ground truth for diagnostic accuracy was not established. The evaluation focused on technical and safety compliance.

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

• Not applicable as there was no formal clinical test set requiring 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:

• No. This device is an MRI RF coil, not an AI/ML driven diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

• No. This device is a hardware component (an RF coil) for an MRI system, not an algorithm or AI. Standalone algorithm performance is not applicable.

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

• For the non-clinical tests, the "ground truth" was compliance with established technical and safety standards (e.g., IEC, NEMA). This involves engineering measurements and evaluations against predefined specifications rather than clinical pathology or expert consensus on diagnostic findings.

8. The sample size for the training set:

• Not applicable. This is a hardware device submission, not a machine learning model. There is no concept of a "training set" in the context of this submission.

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

• Not applicable, as there is no training set.

Summary of Conclusions from the Document:

The GE Healthcare 1.5T GEM RT Open Array coil achieved FDA clearance (K123327) by demonstrating substantial equivalence to a predicate device (K103335, GEM Option for 1.5T MRI Systems) based on:

• Non-clinical testing: Compliance with established international and industry standards for electrical safety (IEC 60601-1, IEC 60601-2-33), electromagnetic compatibility (IEC 60601-1-2), and MRI image quality characteristics like Signal-to-Noise Ratio (SNR) and Uniformity for phased array coils (NEMA MS-9).
• Quality assurance measures: The development process included risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).
• No clinical studies were required to support substantial equivalence for this specific device.

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The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.0T GE MRI Systems for positioning of the pediatric patient.

The Pediatric Positioner Pad Set is a positioning device for pediatric patients used with brain, spine, and neurovascular surface coils in Magnetic Resonance Imaging. It is comprised of foam coated in Polyscan. The Pediatric Positioner Pad Set is comprised of seven components: the Base Pad, the Main Pad, the Child Head Pad, the Infant Head Pad, the two Pad Side Supports, and the Head Strap. The Base Pad rests on the MR System table. The Main Pad is then placed on top of the Base Pad. The patient is positioned on top of the Main Pad. The two Pad Side Supports are secured on either side of the patient via Velcro. Lastly, either the Child Head Pad or Infant Head Pad is used with the Head Strap to hold the patient's head in place. There are two sizes for the head pad to accommodate different patient sizes.

The provided text describes a 510(k) premarket notification for a medical device called the "Pediatric Positioner Pad Set." This device is a passive positioning aid for pediatric patients during Magnetic Resonance Imaging (MRI).

Based on the document, 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

The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., specific accuracy, sensitivity, or specificity values) for the Pediatric Positioner Pad Set. This is because the device is a passive positioning aid and not an active diagnostic or therapeutic device that produces measurable outputs requiring such criteria.

Instead, the document states the device's compliance with qualitative requirements related to its intended use and safety.

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

• Sample Size for Test Set: The document states that a "clinical study on pediatric subjects" was conducted. However, it does not specify the sample size (number of subjects) used in this clinical study (which serves as the "test set" for performance evaluation).
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a GE Healthcare submission to the FDA, it is highly probable the data was collected in the United States. The study was prospective, as it was a "clinical study on pediatric subjects" specifically conducted to support this submission.

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

The document does not mention "experts" being used to establish a formal "ground truth" in the traditional sense (e.g., for diagnostic accuracy). Since this is a positioning device, the "ground truth" would likely be the successful positioning of the patient and the acquisition of diagnostic quality MRI images.

The primary "evaluation" would have been performed by the medical staff (MR technologists, radiologists) involved in the clinical study, who would have assessed the device's ability to facilitate effective patient positioning for image acquisition. Their qualifications are not specified but would implicitly be relevant medical professionals.

4. Adjudication Method for the Test Set

No specific adjudication method (like 2+1, 3+1 consensus) is described, as the evaluation likely revolved around the usability and effectiveness of patient positioning rather than a diagnostic decision requiring such 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

An MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers are assisted by AI. The Pediatric Positioner Pad Set is a passive physical device, not an AI or software-based diagnostic tool.

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

A standalone performance evaluation was not done. Again, this concept applies to algorithms or software. The Pediatric Positioner Pad Set is a physical device that functions with human interaction (positioning the patient) to achieve its intended purpose.

7. The Type of Ground Truth Used

The "ground truth" for this device would be the successful, safe, and stable positioning of pediatric patients for MRI scans, leading to the acquisition of diagnostic quality images. It is not a pathology diagnosis or an outcome measure in the typical sense. The "ground truth" is inherently tied to the practical utility in a clinical setting.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI or machine learning algorithm. Its design and development followed standard engineering and quality system processes, as indicated by the "Quality Assurance Measures" (Risk Analysis, Requirements Reviews, Design Reviews, etc.).

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

Since there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the device's design and development comes from user needs, regulatory requirements, risk analysis, and engineering specifications.

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The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.

The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are surface coils used for Magnetic Resonance Imaging. They are tuned to image Proton nuclei in a receive-only configuration. They are comprised of 32 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques. The 16 Ch version uses multiplexers to allow a 32 channel design to be used on 16 Channel systems.

The GE Healthcare 510(k) Premarket Notification Submission (K103365) describes the Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil. The submission asserts that these devices are substantially equivalent to their predicate device, the USA Instruments Prima III TotalSENSE Torso Coil (K030371).

The study provided to demonstrate substantial equivalence and meet acceptance criteria is based on non-clinical voluntary standards, focusing on safety and performance, rather than clinical efficacy.

Here's a breakdown of the requested 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

The document does not explicitly mention a specific "test set" in terms of patient data. The evaluation appears to be based on testing of the device hardware against engineering and safety standards. Therefore, information regarding "country of origin of the data" or "retrospective or prospective" is not applicable as it's not a clinical study involving patient data.

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

This information is not provided in the document. The evaluation is against engineering standards rather than expert-derived ground truth on clinical images.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication for a test set, as the study relies on compliance with technical standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.

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

Not applicable. This device is a receive-only RF coil for an MRI system, not an algorithm. Its performance is evaluated in terms of its ability to acquire high-quality MR signals.

7. Type of Ground Truth Used

The "ground truth" for this submission is established through compliance with recognized electrical, electromagnetic, and biocompatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1), and performance characteristics like Signal-to-Noise Ratio (SNR) as per a specified method. This is a technical and engineering-based ground truth, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This is a hardware device (MRI coil), not an AI algorithm, so there is no training set in the AI sense.

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

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

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The 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited is hydrogen.

The 8 Channel Cardiac Phased Array 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 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.

The provided text is a 510(k) Premarket Notification Submission for a medical device: "8 Channel Cardiac Phased Array Coil." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a study with detailed performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be present in this document as it pertains to a different type of regulatory submission (e.g., PMA, or specific performance testing for novel devices).

Here's a breakdown based on the available information:

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

This document does not provide a table of acceptance criteria or specific performance metrics as it's a 510(k) submission. A 510(k) aims to demonstrate substantial equivalence to an existing predicate device rather than meeting predefined, numerical performance criteria. The device is considered to have comparable indications for use, safety, and effectiveness to its predicate devices.

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. The document does not describe a "test set" in the context of performance evaluation with a defined sample size for a study. This is a regulatory submission for device clearance based on equivalence.

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 ground truth establishment for a test set is described.

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

Not applicable. No adjudication method for a test set is described.

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 hardware component (an MRI coil), not an AI-powered diagnostic tool. Therefore, MRMC studies comparing human readers with and without AI assistance are irrelevant and not described.

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

Not applicable. This device is an MRI coil, a hardware component for imaging, not an algorithm.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not discussed for this device. The evaluation is based on demonstrating equivalence in terms of safety and technical specifications for an MRI coil.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an algorithm being developed.

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

Not applicable. No training set is mentioned.

Summary of the Study/Submission:

This document is a 510(k) Premarket Notification for the 8 Channel Cardiac Phased Array Coil. The "study" described is a regulatory comparison against predicate devices to demonstrate substantial equivalence.

• Device Description: The 8 Channel Cardiac Phased Array Coil is a receive-only RF coil for Magnetic Resonance Imaging (MRI), tuned to image Proton nuclei. It consists of individual phased array coil elements with integrated preamplifiers to improve image quality, and its geometry is optimized for parallel imaging techniques.
• Intended Use: For use with 1.5T MRI systems manufactured by GE Healthcare to image the heart, mediastinum, and pelvis regions for 2D and 3D MRI, exciting hydrogen nuclei.
• Predicate Devices:
  1. K032045, 8 Channel Cardiac Phased Array Coil
  2. K052584, 1.5T 12 Channel Body Array
• Basis for Substantial Equivalence:
  • The 8 Channel Cardiac Phased Array Coil is essentially the same device as the predicate K032045, with no modifications to accommodate new anatomical regions (the initial submission for K032045 likely covered only cardiac, and this submission seeks to expand to mediastinum and pelvis).
  • Comparison with the 1.5T 12 Channel Body Array Coil (K052584) establishes that the 8 Channel Cardiac Phased Array Coil (an existing device) will now have similar indications for use, particularly for the mediastinum and pelvis, as are covered by the body array coil.
• Conclusion: GE Healthcare considers the 8 Channel Cardiac Phased Array Coil to be as safe, as effective, and its performance substantially equivalent to the predicate devices. The FDA confirmed this finding of substantial equivalence.

In essence, the "study" is a regulatory review illustrating that a specific MRI coil is technologically and functionally equivalent to previously cleared devices for imaging the specified anatomical regions, thus not requiring new, extensive clinical performance studies.

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The GE 3.0T 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.0T MRI system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic, and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.

The 3.0T Head Neck and Spine Coil is a receive-only 16-channel, 29-element coil designed for use with GE 3.0T MRI Systems. This rigid coil incorporates soft, flexible components that conform to patients' anatomy, accommodating various body contours while minimizing patient discomfort. The Head, Neck and Spine Array (HNS) coil is comprised of 4 units: the Head/ Neck Unit (HNU), the Thoracic/ Lumbar unit (TLU) and the Neck Chest Unit (NCU) and Horseshoe. The 3.0T HNS Coil has an array of 21 coil elements in the head neck units and 8 coil elements in the Spine Unit. Twelve coil elements cover the head region. Another four coil elements cover the lower neck and Brachial Plexus regions. Five coil elements cover the upper neck and the chest region. The Spine Unit has an array of 8 coil elements, which cover the thoracic and lumbar spine regions. The 3.0T 16 Channel Head Neck Spine Coil is a multi-element phased array RF Receive only coil with integrated preamplifiers. The coil design consists of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission.

The provided text describes a 510(k) premarket notification for a medical device, specifically a 3.0T 16 Channel Head Neck Spine Coil for MRI systems. While it outlines the device's technical specifications, intended use, and its substantial equivalence to predicate devices, it does not contain information regarding acceptance criteria, performance studies, or clinical trial data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics, pass/fail criteria, or the results of any performance tests.
2. Sample size used for the test set and the data provenance: There is no mention of a test set or the data used for any performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as there's no described test set or ground truth establishment.
4. Adjudication method for the test set: Not applicable as no test set or adjudication process is mentioned.
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 is a hardware device (an MRI coil), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As mentioned above, this is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed.
8. The sample size for the training set: Not applicable as this is a hardware device and not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason.

The document primarily focuses on establishing "substantial equivalence" to existing predicate devices based on design, intended use, and technological principles, which is common for 510(k) submissions for devices like MRI coils. It's not a clinical study report or a performance evaluation for an AI/software device.

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