Search Results

The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.

The MR Instruments FC1500G-8R DuoFLEX® Coil Suite includes three different sets of coil paddles and a single, shared preamplifier box (the "Connector Box") with a system connector. One set of coil paddles is a pair of 24cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The second set of paddles is a pair of 10cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The third set of paddles is a single rectangular, interventional coil containing a single planar loop. All of these paddles connect to the same connector box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 1, 5 or 8 channels for imaging.

The DuoFLEX® Coil Suite (1.5T) 1500G-8R is a specialty magnetic resonance coil used in conjunction with a 1.5T MRI scanner to produce 2D and 3D images. The device is intended for use with GE Healthcare MR Systems and is classified as a Class II medical device (21 CFR 892.1000).

1. Table of Acceptance Criteria and Reported Device Performance

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

The documentation provided does not specify a distinct "test set" in the context of a clinical study or a separate dataset for evaluating an AI algorithm. The device is a hardware component (MRI coil), and its performance was primarily evaluated through non-clinical testing including bench tests, phantom studies, and volunteer scans. The exact number of volunteers or phantoms used for these tests is not specified, nor is the country of origin of the data. Given the nature of a 510(k) for a device like an MRI coil, the focus is on engineering and performance validation rather than large-scale clinical trials.

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

This information is not provided. As per the submission, "This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there was no "test set" in the sense of a clinical image dataset requiring expert-established ground truth for performance evaluation against a diagnostic standard. The "clinical comparison for image quality" described in the non-clinical testing refers to an evaluation of the images produced by the coil, not a diagnostic accuracy study.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, there was no clinical study with a test set requiring adjudication in the context of diagnostic accuracy.

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

No MRMC comparative effectiveness study was done. The submission explicitly states that "This technology is not new, therefore a clinical study was not considered necessary prior to release." The device is an accessory to an MRI scanner, and its equivalence was demonstrated through non-clinical performance and safety testing compared to a predicate device.

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

Not applicable. This device is an MRI coil, which is a hardware component, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation focuses on the engineering and image acquisition capabilities of the coil.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established through:

• Engineering specifications and regulatory standards: for electrical safety, EMC, mechanical properties, and compliance with IEC 60601-1.
• Physical measurements: for SNR (NEMA MS-1 and MS-6) and image uniformity.
• Visual assessment: for image quality (clinical comparison for image quality, volunteer scans, and phantom/cadaver studies), likely made by engineers or experienced MRI operators, comparing the new device's output to established benchmarks or the predicate device's output.

8. Sample Size for the Training Set

Not applicable. This device is a hardware component and does not involve AI algorithms that require a "training set" of data.

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

Not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device

This coil is indicated for use in conjunction with 1.5T and 3.0T GE Healthcare Magnetic Resonance Scanner systems to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.

The MC 1504G-16R (1.5T) and MC 3004G-16R (3.0T) Head Coils are multi-channel receive only coils consisting of 16 RF elements. Each RF element has active and passive blocking networks, and integrated preamplifiers. The MC 1504G-16R RF elements are tuned to 'H at 1.5T (63.9 MHz), while the MC 3004G-16R RF elements are tuned to 'H at 3.0T (127.8 MHz). The coil housing is constructed out of a rigid plastic with an opening for patient viewing and comfort; the head support/base is included with each coil assembly.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and testing:

This document primarily describes the substantial equivalence of a new head coil (MC 1504G-16R and MC 3004G-16R) to existing predicate devices. The focus is on demonstrating that the new device performs similarly to or better than the predicates, rather than establishing acceptance criteria against a specific, quantitative performance threshold for a diagnostic outcome. Therefore, the information provided isn't in the typical format of acceptance criteria for an AI/CADe device where metrics like sensitivity, specificity, or AUC are assessed against predefined targets.

However, based on the text, we can infer the performance comparisons made.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated numbers.
  • Volunteer Scans: "Volunteer scans were performed." The number of volunteers is not specified.
  • Phantoms: "Performance evaluations (phantoms) were completed." The number of phantoms is not specified.
• Data Provenance: Not specified, but generally, such studies for medical device clearance are conducted internally or at partnering institutions within the country of the manufacturer. The study is prospective in nature, involving new scans/tests specifically for this evaluation.

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

• Number of Experts: Not explicitly stated, but "registered technologists in magnetic resonance" were used. This implies more than one.
• Qualifications of Experts: "Registered technologists in magnetic resonance." No specific experience level (e.g., years of experience) is provided. Their role was to assess "equivalence in resulting image quality," meaning they were evaluating the technical quality of the images rather than making clinical diagnoses.

4. Adjudication Method for the Test Set

• Adjudication Method: "Scan images were then reviewed in blind fashion by registered technologists in magnetic resonance." No specific adjudication method (e.g., 2+1, 3+1) is mentioned beyond the blind review. This suggests a qualitative assessment rather than a structured consensus process.

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 done. This device is a hardware component (MRI head coil), not an AI/CADe system designed to assist human readers. Therefore, there's no mention of human reader improvement with AI assistance.

6. 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 or AI system. Its performance is evaluated through physical and imaging characteristics.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For image quality evaluation, the "ground truth" was essentially the subjective assessment of "equivalence in resulting image quality" by "registered technologists in magnetic resonance" when comparing images from the proposed device to images from predicate devices. This can be considered a comparative expert assessment of image quality.
• For physical performance, the "ground truth" was established by engineering specifications and industry standards (e.g., IEC 60601-1 for safety, NEMA MS-1 for SNR measurements).

8. The Sample Size for the Training Set

• Not applicable / No specific training set. As a physical hardware device, there isn't a "training set" in the machine learning sense. The device design and specifications are based on engineering principles and knowledge, not data-driven training.

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

• Not applicable. See point 8.

Ask a specific question about this device

The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (20Na) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis. This device is for prescription use.

The TEM 3002G-HN Dual Tune headcoil is a quadrature transmit/receive RF coil tuned to proton ('H) and sodium (22Na) frequencies 3T. The TEM resonant elements and associated matching and quadrature splitting circuitry are enclosed in a rigid plastic housing to prevent any exposure to patient or environment.

The provided text describes the TEM 3002G-HN Dual Tune Headcoil, which is a medical device for Magnetic Resonance Imaging (MRI). However, it is a 510(k) summary for a physical medical device (an MRI headcoil), not an AI/ML powered device. As such, it does not include information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set sample sizes, which are all typically associated with the evaluation of AI/ML diagnostic tools.

Therefore, the prompt cannot be answered with the provided text because it describes a hardware device, not an AI/ML powered diagnostic tool.

Ask a specific question about this device

The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.

The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.

The provided text describes a 510(k) premarket notification for a medical device, the MC 3003G-32R Head Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria as might be seen for novel devices.

Therefore, the document does not contain information about specific "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, or image quality metrics with thresholds) or a "study that proves the device meets the acceptance criteria" in the way one might expect for a new diagnostic algorithm or AI product.

Instead, the submission for the MC 3003G-32R Head Coil demonstrates substantial equivalence primarily by comparing its design, intended use, and performance to a predicate device, focusing on safety and basic functional performance.

Here's a breakdown of the information that is available in the document, acknowledging that it doesn't directly address the structured questions about acceptance criteria for diagnostic performance:

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

• No specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in the document.
• The document states that "Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met." However, the specific metrics and thresholds for these design specifications and customer requirements are not detailed.
• Reported Device Performance (as implied by the "Summary of Studies"):
  • Electrical bench measurements
  • Electrical/mechanical safety tests
  • System safety and performance tests with phantoms
  • Predicate device comparison tests
  • Volunteer scans
• The primary functional difference highlighted is that the MC 3003G-32R Head Coil has a "32 element phased array RF structure as opposed to a 8 element phased array RF structure" of the predicate, which "may increase coil sensitivity and may reduce data acquisition time." This implies improved performance but doesn't quantify it against specific acceptance criteria.

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

• The document mentions "volunteer scans" as part of the testing activities, but does not specify the sample size of these volunteers.
• Data provenance is not specified. The studies were "conducted using the GE Healthcare Signa 3.0T MR System running standard clinical applications."

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 / Not provided. The "volunteer scans" are mentioned, and the intended use states that "when interpreted by a trained physician yield information that may assist in diagnosis." However, the document does not describe a study involving expert interpretation for establishing ground truth or performance metrics against such ground truth for the device itself. The focus is on safety and technical performance of the coil.

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

• Not applicable / Not provided. Since there's no mention of a diagnostic performance study with expert interpretation for ground truth, there's no adjudication method 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

• No. This device is an MR head coil, a hardware component for image acquisition, not an Artificial Intelligence (AI) diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable. This device is hardware; it is not an algorithm, so a standalone algorithm-only performance study would not apply.

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

• Not explicitly described for diagnostic performance. For the "system safety and performance tests with phantoms," the ground truth would be the known properties and geometry of the phantoms. For "electrical bench measurements" and "electrical/mechanical safety tests," the ground truth would be engineering specifications and safety standards. For "volunteer scans," the purpose seems to be confirming image acquisition capability and safety, rather than a diagnostic performance study against a definitive clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is hardware and does not involve a training set as would an AI algorithm.

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

• Not applicable. As above, no training set for an AI algorithm is involved.

Summary of the Study Mentioned (from "Summary of Studies"):

The study described is a design verification and validation process for a hardware device (an MR head coil). It included:

• Electrical bench measurements: Likely verifying electrical specifications.
• Electrical/mechanical safety tests: Ensuring the device meets safety standards.
• System safety and performance tests with phantoms: Using standardized objects with known properties to assess image quality, signal-to-noise ratio, uniformity, etc., under controlled conditions. This would be a technical performance evaluation, not a clinical diagnostic one.
• Predicate device comparison tests: Direct comparison of the new coil's performance (likely technical and imaging characteristics) against the predicate.
• Volunteer scans: Scans on human volunteers to confirm safe operation and the ability to acquire images, consistent with its intended use for generating images of the head.

The study's goal was to demonstrate that the MC 3003G-32R Head Coil is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness for its intended use, rather than to meet specific diagnostic performance metrics through a clinical trial.

Ask a specific question about this device

The TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is compatible with the 3T Magnetom Trio MR scanner manufactured by Siemens Medical Systems.

The TEM 3000 Head Coil is a 15-element quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent any exposure to patient or environment. The coil housing employs a large open viewing window on the top. The coil design facilitates the scanning of patients with different window on the top: "Ifizes patient comfort and ease of use. Included with the coil housing is a Head Support/Coil Base. It allows the coil to be slid back for better patient access.

The provided text describes a 510(k) premarket notification for the TEM 3000 Head Coil and does not contain information about acceptance criteria or a study proving the device meets them. The document is from 2004 and is a regulatory submission for a medical device rather than a scientific study report.

Therefore, most of the requested information cannot be extracted from this document, specifically:

• 1. A table of acceptance criteria and the reported device performance: Not available. The document is a regulatory filing, not a performance study report.
• 2. Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of a performance study is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• 4. Adjudication method: Not available.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated.
• 6. If a standalone was done: Not indicated.
• 7. The type of ground truth used: Not available.
• 8. The sample size for the training set: Not available.
• 9. How the ground truth for the training set was established: Not available.

What the document does indicate:

The document describes the TEM 3000 Head Coil as a 15-element quadrature transmit/receive coil intended for 'H high-resolution whole-head adult and pediatric imaging, including functional MRI, spectroscopy, and angiography. It is compatible with the Siemens 3T Magnetom Trio MR System.

The submission focuses on establishing substantial equivalence to a predicate device, the Magnetom Trio Head Coil (K021330), based on similar construction and operation, despite using TEM technology instead of "Birdcage" technology. Substantial equivalence in this context means the new device is as safe and effective as a legally marketed device. This is a regulatory pathway, not a clinical performance study with acceptance criteria as typically understood in a scientific evaluation.

Ask a specific question about this device