Search Results

The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation times (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The Gyrex Esteem 1.5T MRI System is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis. surgery planning, or therapy planning and is used in a clinic or hospital setting. The SW Version 5.0 upgrade does not change or contain any additional indications for use.

The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation times (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning. The major components changed or updated over that described in the predicate device submission are: A higher performance gradient amplifier and a water-cooled gradient that when utilized together provide a peak strength of 29mT/M and a slew rate of 60mT/M/msec, An ECG monitoring unit to allow pulse sequences gated to the cardiac cvcle to provide cardiac and pulmonary images with reduced artifact from heart motion, The addition of a phased array spine RF coil for increased FOV coverage in the z-direction, Additional flexibility added to existing user interface software.

Here's an analysis of the provided text regarding acceptance criteria and a device study:

Important Note: The provided documents are a 510(k) submission summary and an FDA clearance letter for a software upgrade to an MRI system. These documents primarily focus on demonstrating substantial equivalence to a predicate device and do not typically contain detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or MRMC studies in the way a clinical trial for a novel AI device would.

Based on the information provided, it's not possible to fully answer all aspects of your request as the document doesn't contain the level of detail typically found in a clinical study report for performance metrics. However, I will extract and infer what I can.

Acceptance Criteria and Study Details from Provided Documents

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the provided documents do not contain a table of explicit, quantitative performance acceptance criteria with corresponding reported performance for the device. The implicit acceptance criterion for a 510(k) submission is that the modified device remains substantially equivalent to its predicate device in terms of safety and effectiveness, and that its indications for use remain unchanged.

The document indicates:

• The software upgrade (Version 5.0) for the Elscint Gyrex Esteem 1.5T MRI System.
• The hardware changes (higher performance gradient amplifier, water-cooled gradient, ECG monitoring unit, phased array spine RF coil) are improvements to the existing system.
• The software update provides "Additional flexibility added to existing user interface software."
• "The SW Version 5.0 upgrade does not change or contain any additional indications for use."

Therefore, the performance is assumed to be at least as good as, if not better than (due to hardware improvements), the predicate device, within the same indications for use. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided or defined as acceptance criteria.

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

The provided documents do not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary for a software upgrade to an existing MRI system where the primary goal is to show equivalence, not clinical performance for a new diagnostic algorithm.

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

The provided documents do not mention any experts used to establish ground truth for a test set. This is consistent with the type of submission, which focuses on hardware/software updates to an existing system, not a new interpretive algorithm.

4. Adjudication Method for the Test Set

The provided documents do not mention any adjudication method for a test set.

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

The provided documents do not indicate that an MRMC comparative effectiveness study was done. The submission is for a device upgrade, not a new diagnostic tool requiring a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

The provided documents do not describe a standalone performance study. The device is an MRI system and its software, which acquires images for interpretation by a trained physician, not an AI algorithm that performs standalone diagnosis.

7. Type of Ground Truth Used

The provided documents do not specify any type of ground truth used for performance evaluation. The "ground truth" concept is not directly applicable in the context of this 510(k) submission, which focuses on the technical specifications and safety/effectiveness of the MRI system itself rather than the diagnostic accuracy of a specific interpretation (which is handled by a trained physician). The "ground truth" for an MRI system's performance would be its ability to produce clinically useful images that, "when interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning."

8. Sample Size for the Training Set

The provided documents do not mention a training set sample size. This is understandable as the submission is for an MRI system's software update, not a machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

The provided documents do not mention how ground truth for a training set was established, as this concept is not applicable to the information contained within these documents.

Summary of Device and 510(k) Approach:

The provided documents detail a 510(k) submission for a software (Version 5.0) and hardware upgrade to an existing Elscint Gyrex Esteem 1.5T MRI System. The key changes are:

• Higher performance gradient amplifier and water-cooled gradient (29mT/M peak strength, 60mT/M/msec slew rate).
• ECG monitoring unit for cardiac/pulmonary imaging.
• Phased array spine RF coil for increased FOV.
• Additional flexibility in user interface software.

The regulatory strategy for this submission is substantial equivalence to the predicate device (Elscint Gyrex Esteem 1.5T MRI System, prior to upgrade). The core assertion is that these modifications do not change the indications for use and that the device remains safe and effective for its stated purpose: producing cross-sectional images for diagnostic, surgery planning, or therapy planning purposes, to be interpreted by a trained physician.

Therefore, the "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate device, ensuring the modifications do not introduce new risks or diminish performance. No detailed clinical performance study with specific metrics, ground truth, or expert evaluation is presented because the device itself is not a diagnostic algorithm, but rather an imaging system whose output is interpreted by a human expert.

Ask a specific question about this device

The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The provided text describes a 510(k) submission for the Elscint Gyrex Prima 1TG 1.0T MRI System, asserting its substantial equivalence to a predicate device, the Prestige 2.0T MRI System. However, this document does not contain explicit acceptance criteria or a dedicated study section demonstrating the device meets such criteria.

The core of this submission is a declaration of substantial equivalence rather than presenting a performance study against specific, quantified acceptance criteria.

Here's an analysis based on the information not present in the document:

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

   • Not provided. The document states that the new device has "changes to RF Coils, sequences and system electronics" and is "substantially equivalent" to the predicate. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, resolution, signal-to-noise ratio) presented for either the new device or against any defined acceptance criteria.

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

   • Not provided. No test set or associated data is described. The submission focuses on device modifications and substantial 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 provided. No test set or ground truth establishment is mentioned.

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

   • Not provided. No test set or 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:

   • Not provided. No MRMC study is mentioned. This device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be applicable in this context. The document does mention "Operator selectable application of the Context Vision™ A imaqe filter," which might involve some image processing, but it's not framed as an AI assistance study for human readers.

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

   • Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent to its imaging capabilities, which are asserted as substantially equivalent to a predicate.

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

   • Not provided. No ground truth is mentioned as there is no specific performance study described.

8. The sample size for the training set:

   • Not applicable/Not provided. As a medical imaging device rather than a machine learning algorithm, the concept of a "training set" in the AI/ML sense is not relevant here. The device's design is likely based on engineering principles and prior knowledge of MRI technology.

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

   • Not applicable/Not provided. As above, a training set with established ground truth, in the context of AI/ML, is not relevant to this device's submission.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a new MRI system to an existing one, rather than a detailed report of a performance study against specific acceptance criteria. It highlights changes in hardware components (magnet, gradient system, coils) and a selectable image filter, asserting that these do not introduce new indications or hazards beyond the predicate device.

Ask a specific question about this device

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

The major components changed or updated over that described in he predicate device submission are:

• A semi-flexible 4-element receive-only phased array pelvic coil for improved pelvic imaging.
• A semi-flexible 4-element receive-only phased array body coil for improved imaging of the liver, kidneys and hips.
• Additional receive-only surface coils for imaging the spine, shoulder, pelvis, and temperomandibular joint:
• A circular polarized spine coil to increase image performance . in the thoracic and lumbar spine when compared to the lumbar spine coil.
• A single loop shoulder coil pair for improved patient comfort . and general utility. Large and small coils for patients of different sizes are provided.
• A circular polarized pelvic coil to improve performance in . imaging pelvic anatomy compared to the body coil alone.
• A bilateral TMJ coil for specialized imaging of . the temperomandibular joint.

In addition, the existing system electronics which contained two RF channels per system has been modified to operate with four RF channels including switching and selection mechanisms for Phased Array operation.

The provided text describes an MRI system and its updated components, but it does not contain acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot fulfill your request for the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (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 describing device updates and ensuring safety parameters are unchanged from a predicate device, along with performance parameters being "substantially equivalent" with listed changes. There is no mention of a study involving acceptance criteria for diagnostic performance or accuracy.

Ask a specific question about this device