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The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.

The 3.0T 16 Channel Brain Spine () Array Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The provided text describes a 510(k) premarket notification for a medical device, specifically a "3.0T 16 Channel Brain-Spine Array Coil". However, it does not explicitly detail the acceptance criteria or a comprehensive study report that proves the device meets specific performance criteria.

The document states: "Testing was performed to demonstrate that the design modifications to the 3.0T Brain / Spine Array meet predetermined acceptance criteria." but does not provide the criteria themselves or the results of the testing beyond a general statement of "substantial equivalence".

Therefore, I cannot provide the requested information for the following sections based on the input:

• A table of acceptance criteria and the reported device performance: The document mentions "predetermined acceptance criteria" but does not list them or report specific performance metrics against them.
• Sample sized used for the test set and the data provenance: No information is provided about the sample size or data origin for any testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: No details on adjudication are provided.
• 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 study type is not mentioned or implied.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a hardware device (MRI coil) and not an AI algorithm, this type of study is not applicable and not mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is described.
• The sample size for the training set: Not applicable for this type of device and study.
• How the ground truth for the training set was established: Not applicable for this type of device and study.

Key takeaway from the provided text:

The document focuses on substantiating the claim of "substantial equivalence" to a predicate device (USA Instruments 3.0T 8 Channel Neurovascular Array coil, K032618) rather than detailing a specific performance study with explicit acceptance criteria. The modifications primarily involve increasing receive channels and integration for improved workflow and patient coverage, which are likely validated through technical engineering tests for signal quality, safety, and compatibility, rather than clinical efficacy studies with ground truth establishment in the traditional sense of diagnostic algorithms. The FDA review also confirms substantial equivalence, allowing the device to be marketed.

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The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen. The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI systems manufactured by GE Medical Systems.

The 1.5T Brain / Spine Array Coil is a receive-only RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine in GE 1.5T MR Imaging systems.

The open design of the 1.5T Brain / Spine Array Coil reduces claustrophobic effects and allows for increased patient comfort. The coil elements are enclosed in a rigid plastic housing. The housing is designed to conform to the patient anatomy. The design of the coil allows for easy positioning of the patient and provides patient comfort.

The mechanical housing of 1.5T Brain / Spine Array Coil consists of four main parts: (1) a main head coil base, (2) a split-top head coil housing (3) a chest coil housing and (4) a T-L Spine housing. The chest coil housing is free floating and it rests on the patient's chest.

The 1.5T Brain / Spine Array Coil has an array of 21 coil elements in the Brain Unit and 8 coil elements in the Spine Unit; The 21 coil elements in the brain unit are Loop elements. Twelve loop coils (L1 to L12) cover the head region. Another four loop coils (L13 to L16) cover the Lower neck and torso regions. Five Loop coils (L17 to L21) cover the upper neck and the chest region. The Spine Unit has an array of four loop coils and four saddle coils which cover the thoracic and lumbar spine regions.

For operation, the 1.5T Brain / Spine Array Coil does not require any change to the software used on the GE Medical Systems Inc. 1.5T MRI system.

The provided text describes a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the 1.5T 16 Channel Brain-Spine Array Coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for an AI/ML device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and AI-specific study details (MRMC, standalone performance) cannot be extracted from this document, as it pertains to the approval of an MRI coil, not an AI/ML diagnostic algorithm.

The document indicates that "Testing was performed to demonstrate that the design modifications to the 1.5T Brain / Spine Array meet predetermined acceptance criteria." However, it does not specify these criteria or the results of the testing.

No information regarding acceptance criteria or a study with performance metrics for an AI/ML device is available in the provided text.

Here's a breakdown of why the requested information is absent or not applicable:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Testing was performed to demonstrate that the design modifications... meet predetermined acceptance criteria," but does not list these criteria or the test results.
• 2. Sample size used for the test set and the data provenance: Not provided. This information is relevant for AI/ML device studies, not for the approval of an MRI coil based on substantial equivalence.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for image interpretation is not part of an MRI coil's 510(k) submission based on substantial equivalence.
• 4. Adjudication method (e.g., 2+1, 3+1, none) 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. This is for AI-assisted diagnostic devices, not MRI hardware.
• 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. This is for AI/ML device development.
• 9. How the ground truth for the training set was established: Not applicable.

Summary from the provided text:

The submission focuses on the substantial equivalence of the "1.5T 16 Channel Brain-Spine Array Coil" to a legally marketed predicate device (Millennium 9000 Phased Array Neurovascular coil K001870). The changes primarily involve physical integration of components and an increased number of receive channels (to 16) to be compatible with GE Healthcare Signa Excite 1.5T MRI Scanners. The comparison emphasizes improved user workflow and more comprehensive patient coverage. The "Summary of Studies" section vaguely mentions "Testing was performed to demonstrate that the design modifications to the 1.5T Brain / Spine Array meet predetermined acceptance criteria," but no details on these criteria or the study results are provided.

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The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.

The USA Instruments 1.5T 12 Channel Torso Coil is a 12- element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. This coil designed for use with the 1.5T Signa Excite MRI scanner, manufactured by General Electric Healthcare. The coil will be available with different connector configurations depending on the configuration of the scanner it will be used with.

The provided text describes a medical device, a Magnetic Resonance Imaging Accessory (1.5T 12 Channel Body Array), and its 510(k) premarket notification. However, the document does not contain detailed information about the specific acceptance criteria or the study that proves the device meets those criteria in the way typically expected for performance claims of AI/ML-based medical devices.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

Acceptance Criteria and Reported Device Performance

Study Information (Based on available text)

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

   • Not specified. The document mentions "Testing was performed," but provides no details about the size or nature of the test set, nor its provenance (country of origin, retrospective/prospective). This device is a hardware component (MRI coil), not an AI/ML algorithm that processes images, so a traditional "test set" with "ground truth" labels for diagnostic performance might not be applicable in the same way. The testing would likely focus on engineering performance, image quality, signal-to-noise ratio, safety, and compatibility.

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

   • Not applicable/Not specified. Given that this is a hardware device (MRI coil) and not an AI-based diagnostic tool, traditional "ground truth" and expert consensus for diagnostic accuracy are not the primary focus of the performance evaluation described. The "acceptance criteria" likely relate to physical and electrical performance, image quality metrics, and safety.

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

   • Not applicable/Not specified. As there's no mention of a diagnostic performance study requiring expert review and adjudication for ground truth, this information is not provided.

4. 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 coil, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described. The comparison is between the new 12-channel coil and an existing 8-channel coil.

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

   • Not applicable. This is a hardware device (MRI coil), not an algorithm.

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

   • Not applicable/Not specified in a diagnostic sense. For a hardware device like an MRI coil, the "ground truth" for its performance evaluation would typically involve objective measurements of signal-to-noise ratio, uniformity, coverage, artifact levels, safety parameters (e.g., SAR, heating), and image quality assessments against established engineering standards or industry benchmarks. These are not explicitly detailed in the summary.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this hardware device.

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

   • Not applicable. There is no "training set" for this hardware device.

Summary of the device's "study" per the provided text:

The "Summary of Studies" section (item 11) states: "Testing was performed to demonstrate that the design modifications to the 1.5T 12 Channel Body Array meet predetermined acceptance criteria." The device is considered "substantially equivalent" to a predicate device (GE Healthcare 1.5T 8 Channel Torso Coil, K031209), primarily due to modifications in the number of elements (12 vs. 8) and coil connector design. The conclusion explicitly states that "Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards." This strongly suggests that the evaluation focused on engineering performance, safety, and compatibility, rather than a diagnostic accuracy study typically associated with AI/ML devices.

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The 3.0T HD Breast Array is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.

The 3.0T HD Breast Array is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four coil elements that are insulated from the patient by a rigid plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The 3.0T HD Breast Array is designed to offer optimized imaging capabilities and maximum lateral and medial access to each breast for biopsy procedures.

The provided text describes a 510(k) submission for a medical device, the "3.0T HD Breast Array." This device is a receive-only RF coil for MRI, intended for obtaining MR images of the breast and axillary tissue. The submission aims to demonstrate substantial equivalence to a previously cleared device (1.5T Liberty 9000 8-channel Breast coil).

It is important to note that a 510(k) submission for a device like an MRI coil typically focuses on physical and electrical performance rather than diagnostic accuracy as a standalone algorithm would. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted in the context of a medical device hardware submission, not an AI/algorithm submission. Many of the requested fields are specifically related to AI/algorithm performance studies and will likely be "Not applicable" or "Not provided" for this type of device submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria." However, specific acceptance criteria and reported device performance metrics are not detailed in the provided text. The overall "performance" claimed is substantial equivalence to the predicate device.

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

This information is Not Applicable / Not Provided in the context of an MRI coil hardware submission. There isn't an "algorithm" being tested with a dataset of medical images. The testing would be on the physical device itself.

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

This information is Not Applicable / Not Provided. Ground truth, in the sense of expert annotation of medical images, is not relevant for the performance testing of an MRI coil.

4. Adjudication Method for the Test Set

This information is Not Applicable / Not Provided. Adjudication methods are used for resolving disagreements among experts annotating medical data; this is not relevant for an MRI coil hardware test.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done/not described for this device. Such studies are typically for evaluating the diagnostic performance of software or imaging modalities, often with human readers involved. This submission is for an MRI coil.

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

This information is Not Applicable / Not Provided. This is an MRI coil, not an algorithm.

7. The Type of Ground Truth Used

This information is Not Applicable / Not Provided. Ground truth, in the sense of pathology, expert consensus, or outcomes data, is not relevant for the performance testing of an MRI coil. The "ground truth" for this device's performance would be engineering specifications and safety standards.

8. The Sample Size for the Training Set

This information is Not Applicable / Not Provided. There is no "training set" in the context of an MRI coil hardware submission.

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

This information is Not Applicable / Not Provided. There is no "training set" or corresponding ground truth for this type of device.

Summary of the Study Proving Substantial Equivalence (as described in the text):

The provided text states: "Testing was performed to demonstrate that the design modifications to the 3.0T HD Breast Array meet predetermined acceptance criteria." The study's objective was to demonstrate substantial equivalence to the predicate device, the "1.5T Liberty 9000 8-channel Breast coil (K041695)." The main difference being the coil was "retuned for operation in a 3.0T magnetic field instead of a 1.5T field strength."

The conclusion drawn from this testing was: "It is the opinion of USA Instruments that the 3.0T HD Breast Array is substantially equivalent to the USA Instruments 1.5T Liberty 9000 8 channel Breast Array (K041695). Usage of the USA Instruments 3.0T HD Breast Array does not result in any new potential hazards."

While the specifics of the tests performed (e.g., SNR measurements, SAR testing, mechanical durability tests) are not detailed in the provided summary, the FDA's clearance letter indicates that they found the device substantially equivalent. The "acceptance criteria" would have been a set of engineering and safety specifications that the 3.0T HD Breast Array needed to meet, demonstrating that its performance and safety profile were comparable to the predicate device, given the change in magnetic field strength.

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The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Open Breast Coil with Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Open Breast Coil with Biopsy Plates is designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System.

The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.

The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Open Breast coil with Biopsy plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.

The provided text describes a 510(k) premarket notification for a medical device called the "Open Breast Coil with Biopsy Plates." This document is a summary of safety and effectiveness, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with detailed acceptance criteria and performance metrics typically found in clinical trials for new technologies.

Therefore, the requested information for acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fully provided from the given document. The document states that the device is similar to a previously cleared device (Liberty 5000 Breast Coil with Disposable Biopsy Plate manufactured by USA Instruments, Inc. - K022007) and its indications for use are the same as for standard MR imaging. This implies that the device is expected to perform comparably to established MRI technology and its predicate.

Here's an attempt to address the points based on the available information, noting where information is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided document, K050128-21, is a Summary of Safety and Effectiveness for a 510(k) submission. For this type of submission, the primary aim is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than to independently prove its performance against a set of specific, quantifiable acceptance criteria through novel studies. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device.

The study described is a comparison of the modified device's features to those of the predicate device, emphasizing their similarities to establish substantial equivalence.

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

Since this is a substantial equivalence claim, explicit "acceptance criteria" against specific performance metrics (e.g., sensitivity, specificity, image quality scores) are not detailed in this document. Instead, the "acceptance criteria" are implied to be the established safety and effectiveness profile of the predicate device and standard MRI imaging. The "reported device performance" is essentially that the new device shares similar characteristics and intended use with the predicate, thereby being safe and effective for its intended purpose.

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

• Sample Size for Test Set: Not applicable/not reported in this document. Substantial equivalence claims often rely on engineering analysis, component comparisons, and adherence to design specifications rather than clinical test sets with patient data. If any testing involved physical measurements or bench tests, the "sample size" would relate to the number of units tested, but this is not specified.
• Data Provenance: Not applicable/not reported. No patient data, country of origin, or retrospective/prospective nature of a study is mentioned. The comparison is against the design and performance characteristics of a previously cleared device.

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

• Number of Experts/Qualifications: Not applicable/not reported. As there is no clinical test set with patient images requiring expert interpretation for ground truth, this information is not relevant to this document.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable/not reported. No test set for clinical performance 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:

• MRMC Study/Effect Size: No. This device is a passive MRI coil accessory, not an AI-powered diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Standalone Performance: Not applicable. This is a hardware component (MRI coil), not an algorithm or software. It does not have "standalone" algorithmic performance.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device (K022007) and the principles of standard MRI imaging. The manufacturer is asserting that the new device, due to its similar design and intended use, will perform equivalently without introducing new risks.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not reported. No machine learning or AI component is described there that would require a training set.

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

• Ground Truth for Training Set Establishment: Not applicable/not reported, as there is no training set for an algorithm.

In summary, the document fulfills the requirements for a 510(k) submission by demonstrating substantial equivalence through a detailed comparison of the new device's features and intended use to those of a predicate device. It does not contain information about clinical studies with specific performance metrics, patient sample sizes, or expert adjudication, as would be expected for a novel diagnostic algorithm or a device requiring new clinical evidence of effectiveness.

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The Millennium III 3T 8-Channel Neurovascular Coil is designed to provide magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 3T 8-Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon parameters (proton density, spin lattice relaxation time T1, and spin spin relaxation time T2) and (3) display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium III 3T 8-Channel Neurovascular Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the head and spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

The provided document is a 510(k) premarket notification for a medical device (Millennium III 3T 8-Channel Neurovascular Coil). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

This document describes a new MRI accessory and demonstrates its substantial equivalence to previously cleared predicate devices. The focus is on comparing the physical characteristics, intended use, indications for use, and safety features (like RF burn prevention and RF absorption) of the new coil to existing, cleared coils.

Therefore, I cannot provide the requested information. The document is not a study report for an AI/ML device that would establish performance metrics against acceptance criteria.

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The Rapture 11000 a phased array peripheral vascular coil is a multi-element phased array RF coil, used for obtaining diagnostic images of the vasculature and soft tissue anatomy extending from below the knee to the foot region, in Magnetic Resonance Imaging Systems. The Rapture 11000 Peripheral Vascular Coil is designed for use with the Signa 1.5T MRI system manufactured by GE Healthcare Technologies. The indications for use are the same as for standard MR Imaging.

The Rapture 11000 a peripheral vascular coil is a multi-element phased array receive-only coil. The coil consists of four sections: two detachable legs sections, a main base and a pre-amplifier box. The open, patient friendly design maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

This document describes the Rapture 11000 Phased Array Peripheral Vascular Coil, an MRI accessory. The submission is a Traditional 510(k) Premarket Notification from 2004.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) submission for a medical device cleared in 2004. At that time, acceptance criteria were typically demonstrated by proving substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics as might be seen for AI/ML devices today. The "acceptance criteria" here are implicitly satisfied by demonstrating the new device is as safe and effective as existing legally marketed devices.

Therefore, the table below reflects the comparison presented in the document to establish substantial equivalence.

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

The document does not detail a specific test set or data provenance in the way an AI/ML device submission would. For a traditional medical device like an MRI coil, "testing" typically involves:

• Engineering validation and verification (e.g., electrical performance, mechanical integrity, safety tests).
• Clinical evaluation to ensure image quality and compatibility with the MRI system.

The submission does not specify a clinical study with a defined sample size for patients. The focus is on demonstrating equivalence based on design, materials, and intended use, implying that similar clinical performance is expected given the similarity to predicate devices. Therefore,

• Sample Size for Test Set: Not specified in terms of patient data.
• Data Provenance: Not applicable in the context of patient data studies for this submission type.

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

This information is not provided in the document. For a traditional MRI coil, "ground truth" would relate to the physical and functional performance of the coil itself (e.g., signal-to-noise ratio, homogeneity, artifact levels), typically assessed by engineers and MR physicists, not medical experts establishing 'ground truth' for diagnostic findings. Since no clinical studies establishing diagnostic truth are mentioned, no expert panel for ground truth is indicated.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are typically used in clinical trials involving subjective interpretation of diagnostic findings, often for AI/ML algorithms or new diagnostic methods where a consensus ground truth needs to be established from multiple expert readers. This submission for an MRI coil focuses on technical equivalence and safety aspects.

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 or at least not reported in this summary. This type of study is common for evaluating the impact of AI on human reader performance for diagnostic tasks. For a physical device like an MRI coil, performance is generally evaluated based on image quality metrics and safety, not on how a human reader's diagnostic accuracy improves with the coil.

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

No, a standalone algorithm performance study was not done. This device is an MRI hardware component, not an algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" would primarily be established through:

• Engineering specifications and tests: Confirming electrical, mechanical, and safety parameters meet design requirements.
• Image quality metrics: Assessing signal-to-noise ratio, image homogeneity, artifact levels, and resolution achievable with the coil.
• Comparison to predicate devices: The primary ground truth for regulatory clearance here is that the new device performs at least as well as or equivalent to legally marketed predicate devices in terms of its intended function and safety.

No specific "pathology," "outcomes data," or "expert consensus" on diagnostic findings is reported as ground truth for this device's performance in the provided summary.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component (an MRI coil), not a software algorithm that requires a training set.

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

Not applicable. As stated above, this device is hardware and does not have a training set or associated ground truth establishment process for training.

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The 3.0T 8-Channel CTL Spine Array is a receive-only phased arrav RF coil used for obtaining diagnostic images of the spine (cervical, thoracic and lumbar regions) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The 3.0T 8-Channel CTL Spine Array is designed for use with the Siemens Medical Systems 3.0T MRI scanner.
The 3.0T 8-Channel CTL Spine Array is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine when used with the Siemens 3.0T scanner manufactured by Siemens Medical Systems, Inc.
The indications for use are the same as for standard imaging:
The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2), and (3) display the soft tissue structure of the body. When interpreted by a trained physician, these images can be useful in the determination of a diagnosis.

The 3.0T 8-Channel CTL Spine Array is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

The provided document, K042186, is a 510(k) premarket notification for a medical device: the 3.0T 8-Channel CTL Spine Array. This application seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than providing extensive independent performance studies with detailed acceptance criteria and clinical outcomes.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader multi-case studies is not explicitly available in this type of regulatory submission. The focus here is on demonstrating similarity to an already approved device.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the new device shares fundamental technological characteristics and intended use with a predicate device, thereby implicitly meeting the safety and effectiveness standards already established for the predicate.

Study Information (Based on 510(k) Submission Type)

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

• Not applicable / Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through technical and functional comparisons, not through a new clinical performance study with a distinct test set of patient data. The safety and effectiveness are inferred from the predicate.

2. 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 / Not provided. Since there wasn't a new clinical performance study with a test set requiring new ground truth, this information is not part of this submission.
• Implicitly, the predicate device would have undergone such evaluations to establish its safety and effectiveness, which would have involved experts.

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

• Not applicable / Not provided. As no new test set was used to establish ground truth for this device, no adjudication method is detailed.

4. 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 a passive MRI accessory (a receive-only RF coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.

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

• No. This is a hardware component (an MRI coil), not a standalone algorithm.

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

• Not applicable / Not provided. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established safety and performance of the predicate device (Premier III Phased Array CTL Spine Coil, K030042). The new device is shown to be technically similar and intended for the same uses, implying it performs equivalently to the predicate.

7. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.

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

• Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment for a training set.

In summary, for a 510(k) submission like K042186 for a hardware component such as an MRI coil, the "study" is primarily a comparative analysis of the device's technical specifications and intended use against a legally marketed predicate device. The acceptance criteria are essentially met by demonstrating substantial equivalence to the predicate in terms of safety and effectiveness, based on similar technology, materials, design, and intended use. New clinical studies with patient data, ground truth establishment, or multi-reader reviews are typically not part of such a submission unless there are significant technological differences or new indications for use.

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The Mark III Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark III Phased Array Coil is designed for use with the Signa EXCITE 3T MRI scanner manufactured by GE Medical Systems, Inc.

The Mark III Phased Array Coil consists of three volume RF coil elements in a phased array design. The coil elements and associated circuitry are enclosed to prevent any exposure to the patient or environment. The coil electronics are enclosed in both the rigid housing and the vinyl coated PVC foam. The coil is positioned on the patient's shoulder during imaging.

The provided text describes a Special 510(k) Premarket Notification for the Mark III Phased Array Shoulder Coil. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical or performance study data with defined acceptance criteria in the same way a new, high-risk device might. The document submitted for K042009 is a Traditional 510(k), which is typically for new devices. However, the internal title indicates 'Special 510(k)', which refers to an easier route for devices that are modifications to one's own legally marketed devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document. The 510(k) submission primarily relies on comparisons to legally marketed predicate devices to establish safety and effectiveness.

Here's an analysis of what is available and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative performance metrics (e.g., signal-to-noise ratio, image resolution, specific absorption rate (SAR) limits) that the device must meet, and corresponding test results to prove these metrics are met. The document states "power deposition during imaging is limited by SAR algorithm", but doesn't specify the accepted SAR limits or the measured SAR of the device.

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

Missing Information: The document does not describe a "test set" in the context of clinical or performance data generation. The submission relies on a comparison to predicate devices, not independent testing on a new dataset.

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

Missing Information: Not applicable. No test set requiring expert ground truth is described.

4. Adjudication Method for the Test Set

Missing Information: Not applicable. No test set requiring adjudication is described.

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

Missing Information: No MRMC study is described. The submission focuses on technical equivalence rather than clinical comparative effectiveness.

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

Missing Information: Not applicable. This device is a passive RF coil, not an algorithmic device requiring standalone performance testing in that sense. The 'performance' is implied by its design similarity to predicate devices.

7. The Type of Ground Truth Used

Missing Information: Not applicable. No new ground truth needed to be established for this submission, as it relies on the established safety and effectiveness of predicate devices.

8. The Sample Size for the Training Set

Missing Information: Not applicable. This device is a hardware component, not an AI/ML algorithm that requires a training set.

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

Missing Information: Not applicable. No training set is described.

Summary of the Study/Evidence Provided:

The "study" presented in this 510(k) notification is primarily a direct comparison of the Mark III Phased Array Shoulder Coil to legally marketed predicate devices. The manufacturer, USA Instruments, Inc., established substantial equivalence by demonstrating that their new coil has:

• Similar Intended Use: Shoulder imaging applications.
• Similar Indications for Use: Identical to routine MRI imaging.
• Similar Design Principles: Receive-only phased array design, decoupling methods (switching diode decoupling), and methods for preventing RF burns (does not transmit RF power, coil elements isolated and enclosed in non-conductive housing).
• Similar Materials: Coil enclosure materials (Vinyl coated PVC foam, Flame retardant Polyurethane Plastic, PVC Plastic).

Predicate Devices Used for Comparison:

• Mark 9000 Shoulder Coil manufactured by USA Instruments Inc. (K010946)
• Phased Array Shoulder Coil manufactured by Medical Advances Inc. (K945778)
• Magna 5000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K994345) (for enclosure materials)
• Excalibur 9000 TotalSENSE™ Quad Array-Head Coil manufactured by USA Instruments, Inc. (K022582) (for prevention of RF burns)

The safety and effectiveness argument is built upon the premise that because the Mark III Phased Array Shoulder Coil shares fundamental design characteristics, intended use, and indications for use with other legally marketed devices, it can be considered equally safe and effective. The FDA's letter concurs with this determination of substantial equivalence.

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The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the Excite 1.5T system, manufactured by General Electric Healthcare.

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner.

The indications for use are the same as for standard imaging:

The Signa Excite 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue reluxation and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is a phased array, receive-only MRI coil. The coil consists of a main supporting base with a coil chamber in the middle section. A sternum bridge and two lateral wings divide the chamber into two segments, one to receive each breast. Each of the hollow coil segments houses four coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.

The provided text is a 510(k) premarket notification for a medical device, specifically a "Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate" for Magnetic Resonance Imaging. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data to prove performance against specific acceptance criteria. Therefore, the document does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert qualifications, or ground truth establishment in the way typically seen for new diagnostic algorithms or devices requiring extensive clinical validation.

The document primarily focuses on:

• Device Description and Intended Use: Detailing the physical characteristics and purpose of the breast coil.
• Comparison to Predicate Devices: Explicitly stating that the device is "Similar to Liberty 9000 Breast Coil with Disposable Biopsy Plate" (K001582) and other cleared devices, emphasizing similarities in features, intended use, indications for use, and safety aspects.
• Safety Features: Highlighting design aspects that mitigate risks like RF burns and resonant loops (e.g., receive-only coil, decoupling, non-conductive housing).

Given this context, I will address the requested points by explaining why the information is not present in the provided text for a 510(k) submission of this nature.

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

Information Not Available: This document does not present a table of acceptance criteria or reported device performance metrics in the way one would expect for a novel diagnostic algorithm or a device requiring new performance claims. As a 510(k) submission for a medical device accessory (an MRI coil), the focus is on demonstrating that the device is substantially equivalent to a legally marketed predicate device, particularly in terms of safety and functionality. Performance is implicitly demonstrated by showing it functions similarly to the predicate for its intended use (obtaining MR images of the breast).

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

Information Not Available: No specific test set, patient data, or clinical study data (prospective or retrospective) from which performance metrics would be derived is mentioned in this 510(k) summary. The submission relies on a comparison to predicate devices, engineering design specifications, and safety assessments rather than new clinical trials with patient cohorts.

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)

Information Not Available: Since no specific test set or clinical study is described, there is no mention of experts used to establish ground truth or their qualifications.

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

Information Not Available: No test set or clinical study is described, so no adjudication method 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

Information Not Available: This document describes an MRI breast coil, which is a hardware accessory, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant and not mentioned.

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

Information Not Available: This device is an MRI coil, a hardware component, not a standalone algorithm. Thus, this question is not applicable.

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

Information Not Available: As no clinical studies or test sets are described, there is no mention of the type of ground truth used.

8. The sample size for the training set

Information Not Available: This device is an MRI coil, not an AI-driven algorithm, so the concept of a "training set" is not applicable in this context.

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

Information Not Available: As the concept of a "training set" does not apply to this device, the establishment of ground truth for such a set is not mentioned.

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