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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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It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.

The 8 Channel Cardiac Phased Array Coil is a modification to the 8 Channel Cardiac Phased Array Coil (K022669), which features a flexible anterior half of the coil.

The provided text is a 510(k) summary for a medical device, specifically an 8 Channel Cardiac Phased Array Coil. It details the device's modification from a predicate device and states that testing was performed to demonstrate that the design modifications meet predetermined acceptance criteria. However, the document does not explicitly state what those acceptance criteria are, nor does it provide details of the study that proves the device meets them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Based on the provided text, the following information can be extracted:

• Device Name: 8 Channel Cardiac Phased Array Coil
• Purpose of the study: To demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria.
• Conclusion: GE states that the modified device is substantially equivalent to the predicate device (K022669) and does not result in any new potential hazards.

Missing Information:
All of the following information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on regulatory approval based on demonstrating substantial equivalence, rather than a detailed scientific study report with specific performance metrics and validation methodologies.

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It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.

The 8 Channel Cardiac Phased Array Coil is a modification to the Cardiac Phased Array Coil (K971667), which utilizes an increase in the number of independent receive channels from four to eight, integrates preamplifiers, and utilizes ASSET optimized geometry.

The provided text describes a 510(k) submission for the "8 Channel Cardiac Phased Array Coil" by GE Medical Systems. While it states that "Testing was performed to demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria," the document does not elaborate on what those specific acceptance criteria were or detail the study that proved the device met them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices (GE Cardiac Phased Array Coil K971667 and MRI Devices Corporation HRH-63-8 Head Array Coil K013159) based on design modifications such as:

• Increase in independent receive channels from four to eight.
• Integration of preamplifiers.
• Optimization for ASSET applications.

The only statement related to performance or testing is very general.

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It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging

The Cardlac Phased Array Coil is a receive only coil with two separate coils matched with a front and a back (anterior and posterior) section.

Here's an analysis of the provided documents regarding the GE Medical Systems Cardiac Phased Array Coil, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document K971667 is a 510(k) summary for a medical device cleared in 1997. It is important to note that the level of detail regarding performance studies and acceptance criteria in 510(k) summaries from that era is significantly less comprehensive than what is typically expected for modern AI/ML device submissions. Therefore, many of the specific details requested in your prompt (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications for AI studies, MRMC studies, standalone performance) are not present in this document, as they are not applicable to the type of device (a medical coil) or the regulatory standards of that time.

Acceptance Criteria and Reported Device Performance

The Cardiac Phased Array Coil is a receive-only coil intended for use in MRI of the heart and mediastinum. Its substantial equivalence to predicate devices is based on similar construction, circuitry, and adherence to established performance standards for such equipment.

Details on the Study Proving Device Meets Acceptance Criteria

Given that this is a 510(k) summary for an MRI coil from 1997, the "study" referred to is primarily the testing against established engineering and safety standards, and a comparative analysis against predicate devices. It is not a clinical trial or performance study in the sense of evaluating an AI algorithm's diagnostic accuracy.

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

   • Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. For an MRI coil, "testing" would involve physical and electrical measurements of the coil's performance. The specific number of coils tested or the "sample size" of signal acquisitions performed during testing are not detailed but would be standard engineering validation activities.
   • Data Provenance: Not applicable in the context of AI/ML. The device itself is hardware. Testing would be performed in a controlled laboratory or clinical environment. Information on country of origin or retrospective/prospective nature is not provided, and not relevant for this type of device.

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

   • Not applicable. Ground truth, in the context of AI, refers to medically confirmed diagnoses or annotations. For an MRI coil, "ground truth" would relate to accurate physical measurements and adherence to engineering specifications, typically established by engineers and technicians.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation studies. This is not relevant for an MRI coil.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is designed to assess the impact of a new diagnostic tool (often software or an AI algorithm) on human reader performance. This device is an MRI coil, a hardware component, not a diagnostic software tool that assists human readers.

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

   • No. This question is also highly relevant for AI algorithms. The Cardiac Phased Array Coil does not have "standalone" performance in the AI sense, as it is a component of an MRI system. Its performance is measured by its electrical characteristics and image quality contribution when integrated into the MRI system.

6. The type of ground truth used:

   • For this device, "ground truth" would refer to engineering specifications, electrical measurement standards, and safety standards. For example, the "ground truth" for SNR would be a defined measurement protocol and a target value based on NEMA MS#6. The "ground truth" for electrical safety would be adherence to the limits set by IEC 601-1. This is not pathology, outcomes data, or expert consensus in the diagnostic sense.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

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

Summary Specific to K971667:

The provided document indicates that the GE Medical Systems Cardiac Phased Array Coil was evaluated against the NEMA performance standard MS#6 for Special Purpose Coils and the IEC 601-1 International medical equipment safety standard. The "study" consisted of these evaluations and a comparison to predicate devices (ScanMed Cardiac/Vascular Coil and GE Pelvic Phased Array Coil) to establish substantial equivalence. The document explicitly states: "The Coil is comparable to the predicate devices." No clinical performance data, AI algorithm evaluations, or specific numerical performance metrics are provided in this summary, as these were not typically required or relevant for MRI coil 510(k) submissions in 1997. The acceptance criteria were met by demonstrating adherence to these established hardware performance and safety standards, and by showing equivalence to already marketed devices.

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