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The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.

The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.

This document describes a 510(k) premarket notification for the GE Healthcare 3.0T 16ch AIR AA, a receive-only RF coil for MRI systems. The submission asserts substantial equivalence to a predicate device (1.5T 16ch AIR AA, K182590) based on non-clinical and clinical testing.

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

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

• Non-Clinical Testing: The document does not specify a "sample size" in terms of number of patients or cases for the non-clinical tests (SNR, Uniformity, Heating, etc.). These tests are typically performed on the device itself under controlled laboratory conditions. The data provenance is implied to be from GE Healthcare's testing facilities.
• Clinical Testing: The document states "sample clinical images have been obtained from various anatomies and using various pulse sequences." The exact number of images, patients, or cases is not specified. The provenance of this data (e.g., country of origin, retrospective or prospective) is also not specified.

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

• Non-Clinical Testing: Ground truth for non-clinical tests is based on established engineering standards (NEMA, IEC, AAMI/ANSI, ISO). No human experts are explicitly mentioned for establishing ground truth in this context, as measurements are objective.
• Clinical Testing: The diagnostic quality of the sample clinical images was "assessed by a U.S. Board Certified Radiologist." This indicates one expert was used. Their qualification is a "U.S. Board Certified Radiologist." The exact experience level (e.g., 10 years) is not specified.

4. Adjudication Method for the Test Set

• Non-Clinical Testing: Not applicable, as objective standards are used.
• Clinical Testing: Inferred as none, as only one radiologist assessed the images for diagnostic quality. There is no mention of multiple readers or an adjudication process.

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

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "sample clinical images have been obtained... and determined to be of diagnostic quality" by a single radiologist. There is no mention of comparing human readers with and without AI assistance, or any effect size. This device is a hardware component (MRI coil), not an AI algorithm designed to assist human readers.

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

• This question is not directly applicable as the device is an MRI receive coil, which is a hardware component, not an AI algorithm. The performance being evaluated is the image quality and safety of the coil itself. The clinical testing focuses on whether the images produced by the coil are diagnostically acceptable.

7. The Type of Ground Truth Used

• Non-Clinical Testing: Ground truth is based on engineering standards and direct physical measurements (e.g., SNR values, temperature readings, electrical parameters).
• Clinical Testing: Ground truth for image diagnostic quality is based on expert consensus (specifically, the assessment of a U.S. Board Certified Radiologist).

8. The Sample Size for the Training Set

• Not Applicable. This document describes the clearance of a hardware device (an MRI coil), not an AI algorithm that requires a training set.

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

• Not Applicable. As mentioned above, this is a hardware device approval, not an AI algorithm.

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The 3.0T AIR MP M is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.

The 3.0T AIR MP L is a receive only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.

The 3.0T AIR MP M is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 20 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP M is provided with P-connectors. The coil has a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.

The 3.0T AIR MP L is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities and are designed for use with GE 3.0T MRI Systems. This is a 21 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T AIR MP L is provided with P-connectors. The coil has a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.

The provided text describes a 510(k) premarket notification for an MRI coil, not an AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria, study design for performance, and ground truth for AI algorithms is not applicable.

However, I can extract the relevant information about the device itself and the non-clinical testing conducted to demonstrate substantial equivalence, which serves as the "proof" the device meets certain criteria for safety and performance.

Device Description and Intended Use:

The devices are the 3.0T AIR MP M (20 elements) and 3.0T AIR MP L (21 elements), which are receive-only RF coils designed for use with GE 3.0T MRI systems to produce diagnostic images on general human anatomy, including extremities. The nucleus detected is hydrogen.

1. Table of acceptance criteria and the reported device performance

Since this is an MRI coil, "acceptance criteria" and "device performance" are primarily related to safety, electromagnetic compatibility, and image quality as demonstrated through non-clinical testing against recognized standards. The document states the device performs "as intended" based on these tests.

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 explicitly states: "The subjects of this premarket submission, the 3.0T AIR MP M and 3.0T AIR MP L, do not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that there was no formal "test set" in the context of a clinical study for performance evaluation. The "sample clinical images" would likely be for illustrative purposes rather than a statistically powered test set for performance metrics. Therefore, details about sample size (beyond "sample images"), data provenance, retrospective/prospective nature are not provided and likely not relevant for this type of device submission.

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, as no formal clinical test set or ground truth establishment by experts for performance evaluation was conducted or required.

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

Not applicable, as no formal clinical test set or ground truth establishment was conducted or required.

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 is an MRI coil, not an AI/ML device.

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

Not applicable. This is an MRI coil, not an AI/ML device.

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

Not applicable, as no formal ground truth was established for a clinical performance study. The "ground truth" for this type of device is implicitly tied to its ability to produce diagnostic quality images that are comparable to a predicate device, as verified through physical and electrical testing against recognized standards.

8. The sample size for the training set

Not applicable. This is an MRI coil, not an AI/ML device. There is no "training set" in this context. The development process involves engineering and quality assurance, not machine learning model training.

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

Not applicable. This is an MRI coil, not an AI/ML device.

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The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.

This document is a 510(k) premarket notification for a medical device, specifically a 48CH Head Coil for MRI systems. The FDA letter and the 510(k) summary provided indicate that this device is being submitted as substantially equivalent to a previously cleared predicate device (48CH Head Coil, K163205).

Key takeaway: The regulatory submission explicitly states that clinical studies were not required to support substantial equivalence for this device. This means the information requested about acceptance criteria, detailed study design (sample size for test/training sets, number of experts, adjudication, MRMC, standalone performance, ground truth establishment) is largely not applicable in the context of this specific 510(k) submission.

The submission focuses on non-clinical testing to demonstrate that the device is as safe and effective and performs in a substantially equivalent manner to the predicate, despite a minor design change (decoupling circuit).

Therefore, I cannot provide the requested information about acceptance criteria for a clinical study or a detailed study description because the submission states that no clinical studies were performed or required.

Here's what can be extracted and inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study" for this specific type of submission:

Acceptance Criteria and Study for Substantial Equivalence (Non-Clinical Focus)

Since this 510(k) relies on substantial equivalence established through non-clinical testing, the "acceptance criteria" are not for clinical performance metrics (like sensitivity/specificity of an AI algorithm), but rather for demonstrating that the new device performs equivalently to the predicate in terms of safety and technical specifications.

1. Table of "Acceptance Criteria" and "Reported Device Performance" (Non-Clinical Context):

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

• Not Applicable. No clinical test set data was reported as part of this 510(k) submission. The testing performed was non-clinical (e.g., electrical, thermal, mechanical bench testing).
• The document explicitly states: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence."

3. Number of Experts Used and Qualifications:

• Not Applicable. No clinical ground truth was established by experts for a test set, as no clinical study was performed or required.

4. Adjudication Method:

• Not Applicable. No clinical test set to adjudicate.

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

• Not Applicable. No clinical study comparing human reader performance with or without AI assistance was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic algorithm.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. This device is an MRI coil, not a standalone algorithm.

7. Type of Ground Truth Used:

• Not Applicable for clinical ground truth. For the non-clinical testing, the "ground truth" would be established engineering specifications, safety standards (e.g., IEC 60601 series), and performance metrics of the predicate device against which the new device was compared (e.g., signal-to-noise ratio measurements, temperature limits, B1 field uniformity targets).

8. Sample Size for the Training Set:

• Not Applicable. This device is an MRI coil, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable. No training set exists for this type of device.

In summary, the provided document clearly states that this 510(k) submission for the 48CH Head Coil did not require clinical studies to demonstrate substantial equivalence, relying instead on non-clinical testing. Therefore, the detailed questions related to clinical study design, data, experts, and ground truth are not applicable to the information contained within this regulatory filing.

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The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. The nucleus detected is hydrogen.

The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. The nucleus detected is hydrogen.

The AIR Anterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone. The AIR Anterior Array contains 30 elements and the housing of the AIR Anterior Array is made of a soft, pliable material that conforms to the patient's anatomy. The coil is padded with a soft material designed to maximize patient comfort.

The AIR Posterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the spine, abdomen, torso, pelvis, prostate, cardiac, hips and long bone. The AIR Posterior Array contains 60 elements and is embedded within the patient table of the MR System.

The provided text describes GE Healthcare's AIR Anterior Array and AIR Posterior Array, which are receive-only RF coils for GE 3.0T MRI Systems. The submission focuses on demonstrating substantial equivalence to predicate devices (3.0T AA for Anterior Array and TDI Posterior Array for Posterior Array, both K143345) rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and performance against those criteria as would be found in a study for a new clinical claim is not present.

However, I can extract the information that is available regarding the comparison to predicate devices and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission demonstrating substantial equivalence to existing predicate devices, explicit, quantifiable "acceptance criteria" for a new clinical performance claim are not provided in the same way they would be for a de novo device or a device seeking a novel indication. Instead, the "acceptance criteria" are implied by compliance with established standards and comparable performance to the predicate device.

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

The submission explicitly states: "The subjects of this premarket submission, the AIR Anterior Array and AIR Posterior Array, do not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that a formal test set, in the sense of a clinical trial or large-scale evaluation, was not conducted. The "sample clinical images" suggest a limited number of images were used for visual comparison, but the exact number, their provenance, or whether they constituted a formal "test set" for quantitative analysis is not specified.

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

Given that formal clinical studies were not required and "sample clinical images" were provided, it is highly unlikely that a formal ground truth establishment process involving multiple experts was undertaken for these images. The evaluation would have likely been internal to GE Healthcare’s regulatory and engineering teams, comparing the images to those obtained with the predicate device. Therefore, this information is not available.

4. Adjudication Method for the Test Set

As a formal test set and expert review for ground truth are not described, an adjudication method is not applicable and not mentioned.

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

No MRMC comparative effectiveness study was performed. The submission explicitly states "do not require clinical studies to support substantial equivalence." The focus is on demonstrating equivalence through technical comparison and non-clinical testing.

6. Standalone (Algorithm Only) Performance Study

These devices are MRI coils, which are hardware components, not algorithms. Therefore, a standalone (algorithm only) performance study is not applicable. The performance is intrinsically linked to the MRI system.

7. Type of Ground Truth Used

For the "sample clinical images," the ground truth implicitly would have been standard clinical interpretation by radiologists, but this was not part of a formal study with documented "ground truth" establishment. For the non-clinical tests, the ground truth was derived from the compliance with engineering standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, etc.) and successful completion of internal verification and validation activities.

8. Sample Size for the Training Set

There are no algorithms or AI described for these devices, so the concept of a "training set" is not applicable. The devices are hardware components (MRI coils).

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

Not applicable, as there is no training set for these devices.

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The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality and a custom MEMS (Micro Electro Mechanical System) switch to decouple the receive coil from the MR System body coil. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.

The provided document describes a 510(k) premarket notification for the GE Healthcare 48CH Head Coil. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria for diagnostic performance.

Therefore, the information you requested about acceptance criteria and how a study proves the device meets them, particularly regarding AI performance, human reader improvement, and ground truth establishment, is largely not present in this submission. This is typical for a device like an MRI coil, where the focus is on safety, technical performance (signal-to-noise ratio, uniformity, etc.), and demonstrating that it operates similarly to existing approved devices.

Here's a breakdown of what can be extracted from the document, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of clinical acceptance criteria for diagnostic imaging performance (e.g., sensitivity, specificity for detecting specific conditions). Instead, it focuses on non-clinical technical performance and safety.

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

• Test set for clinical performance: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that there was no formal clinical test set for diagnostic performance as would be used for an AI device. The included "sample clinical images" are likely illustrative rather than for formal evaluation.
• Data provenance: Not applicable for a separate clinical test set.

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

Not applicable, as no dedicated clinical test set with ground truth was required for this submission.

4. Adjudication method for the test set

Not applicable, as no dedicated clinical test set with ground truth was required for this submission.

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 MRMC study was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic tool.

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

Not applicable. This device is an MRI coil, not an algorithm.

7. The type of ground truth used

Not applicable for clinical performance. For non-clinical tests, the ground truth would be based on engineering specifications, physical measurements, and compliance with established safety standards.

8. The sample size for the training set

Not applicable. This is a hardware device (MRI coil), not a software algorithm requiring a training set in the AI sense.

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

Not applicable.

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