Search Results

MAGNETIC RESONANCE IMAGING WHOLE BODY

The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation.

Here's an analysis of the provided text regarding the Elscint MRI Software Version 3.0, focusing on acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implicitly defined by comparison to the predicate devices. The submission claims the device is "substantially equivalent in safety and effectiveness" and that effectiveness is "improved in non-substantial ways." The actual "study" presented is a direct comparison of technical specifications.

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

• Sample Size for Test Set: Not applicable. The submission does not describe a clinical study with a "test set" of patient data. The effectiveness evaluation is based on a technical parameter comparison to predicate devices, not on a dataset of images or patients.
• Data Provenance: Not applicable. No clinical data is mentioned.

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

• Not applicable. No ground truth for a test set was established. The "truth" is based on the technical specifications of the device and its predicate.

4. Adjudication Method for the Test Set

• Not applicable. There was no test set or expert adjudication process described.

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

• No MRMC comparative effectiveness study was done. The document does not describe human reader performance or the impact of AI assistance. The focus is on the inherent technical capabilities of the MRI system's software version.

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

• Not explicitly described as a "standalone study" in the modern sense of AI algorithm evaluation. However, the performance metrics (e.g., minimum TE, TR, FOV) inherently represent the standalone capabilities of the MRI "algorithm" or system software without direct human intervention during the acquisition process. The assessment is purely on the system's technical output.

7. Type of Ground Truth Used

• The "ground truth" for this submission is the technical specifications and performance parameters of the predicate MRI devices. The new software version's performance is compared directly to these established technical benchmarks. There is no biological or clinical ground truth (e.g., pathology, outcomes data) discussed.

8. Sample Size for the Training Set

• Not applicable. This submission describes software updates to an MRI system, not an AI or machine learning model that would 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/ML model.

Ask a specific question about this device

The production of a series of images of the heart at different phases of the cardiac cycle.

The modification is a cardiac gating technique referred to as Retrospective Gating. In standard cardiac gating, the acquisition is triggered by the QRS pulse of the ECG. In Retrospective Gating, the scan runs continuously, and the correlation with the QRS cycle is done after the fact. This modification does not involve any changes to the existing hardware of the predicate devices.

The provided 510(k) summary for Elscint's "Retrospective Gating for Elscint MRI Systems" describes a modification to existing MRI systems. However, its focus is on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a detailed study.

Here's an analysis of the submission based on your request, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated. The submission mentions image comparability to existing techniques but does not quantify the sample size (number of patients/scans) used to assess this comparability.
• Data Provenance: Not explicitly stated. Given it's a 510(k) for a device modification, it's likely the "comparable images" refer to internal testing performed by Elscint. It does not specify country of origin or whether it was retrospective or prospective data.

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

• Not applicable / Not explicitly stated. The submission focuses on demonstrating safety and "comparable" image quality to an existing method, implying visual assessment by company engineers/experts. There is no mention of independent experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

• Not applicable / Not explicitly stated. No formal adjudication method is described, as the study design for evaluating "comparability" is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size

• No. A formal MRMC comparative effectiveness study, as understood in current regulatory submissions for AI/CAD devices, was not performed or described. This submission predates the widespread use of such studies for AI evaluation in medical imaging. The submission simply states images are "comparable" to standard gating.

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

• Yes, implicitly. This is a modification to an MRI system's acquisition technique, not an AI/CAD algorithm that provides diagnoses or measurements. The "performance" being evaluated is the direct output of the modified MRI system (the images themselves). The statement "The Retrospective Gating option produces images that are comparable with those produced using the standard cardiac gating technique" implies a standalone assessment of the image quality produced by the system.

7. The Type of Ground Truth Used

• Implied Expert Observation/Standard of Care: The "ground truth" here is the established quality and diagnostic utility of images produced by the standard cardiac gating technique. The new technique simply needed to demonstrate that its output images were similar in quality and diagnostic information. This would have been assessed by developers and possibly clinical collaborators comparing the two sets of images. It's not "pathology" or "outcomes data" in the typical sense for a diagnostic algorithm, but rather a performative comparison to an existing, validated imaging method.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device modification is to an MRI acquisition technique, not an AI / machine learning algorithm that requires a "training set" in the modern sense. The term "training set" is not relevant to this submission.

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

• Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment process in this context.

Summary of the Study:

The "study" described in the 510(k) summary is a comparative assessment aimed at demonstrating substantial equivalence to predicate devices. It's not a formal, quantitative performance study with specific metrics, statistical power, and independent adjudication typically seen for novel diagnostic devices. Instead, it relies on proving that the new "Retrospective Gating" technique maintains the same safety profile and produces comparable image quality to established cardiac gating methods within Elscint's existing MRI systems (Gyrex 2T Prestige, Gyrex Privilege, Gyrex Prima 1 TG System). The critical assertion is that "the effectiveness of the modified devices is similar to that of the predicate devices." No detailed study protocol, data, or statistical analysis is provided in this summary. It's a high-level claim of equivalence.

Ask a specific question about this device

What the user provided is a comprehensive overview of a medical device, which contains the intended use/indications for use. When asked to output the intended use as it appears in this document, the following is provided:

Whole Body Magnet Resonance Imaging

The modification is a new imaging sequence referred to as Echo Planar Imaging (EPI). EPI is an imaging technique which produces multiple gradient echoes after an initial RF excitation, thereby allowing faster imaging than standard gradient echo techniques.

Here's a breakdown of the acceptance criteria and study information for the Elscint EPI for the Gyrex Prestige and Privilege Systems, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to "images that are comparable with those produced using other imaging sequences" but does not detail a specific test set. This suggests a more general comparison rather than a formal study with a defined test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment for a specific test set is not described. The evaluation appears to be a general assessment of image comparability.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is an imaging sequence modification, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging sequence modification, not an algorithm with standalone performance metrics. The effectiveness is assessed by the quality and utility of the generated images.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "effectiveness" section states that EPI sequences produce images that are "comparable with those produced using other imaging sequences." This implies a qualitative assessment of image quality and diagnostic information content, likely against established clinical standards or the predicate device's image quality. It's an assessment of image fidelity rather than a ground truth for a diagnostic task.

7. The sample size for the training set: Not applicable. This document describes a modification to an MRI system's imaging sequence, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Not Found

The current modification to the Gyrex 2T-Prestige consists of the addition of software to enable the production of 'H spectra are produced using the existing MRI hardware.

The spectroscopy software includes automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction and display, and higher level spectral processing functions.

This document is a 510(k) summary for a device called "Gyrex 2T Prestige 'H Spectroscopy Option." It's a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the way you've outlined. This document is a regulatory submission focused on demonstrating substantial equivalence, not on presenting a clinical or performance study with detailed acceptance criteria and results.

Here's why and what information can be extracted:

• Acceptance Criteria/Performance Table: Not applicable because no performance study is described. The document only states "The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device)." It doesn't quantify this similarity or list specific performance metrics it had to meet.
• Sample size and data provenance: No performance study is described, so no sample size or data provenance is provided.
• Number of experts and qualifications: No performance study is described that involved experts establishing ground truth.
• Adjudication method: Not applicable as no performance study with ground truth adjudication is described.
• MRMC comparative effectiveness study: Not applicable as no such study is described.
• Standalone performance: Not applicable as no standalone performance study is described. The submission focuses on the addition of software to existing MRI hardware to enable 'H spectroscopy.
• Type of ground truth: Not applicable as no performance study with ground truth is described.
• Sample size for training set: Not applicable as no machine learning model requiring a training set is described. The modification is described as "software to enable the production of 'H spectra."
• Ground truth for training set: Not applicable as there's no training set described.

Summary of available information related to your questions:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Implicitly, the device must perform similarly in effectiveness to the predicate device (GE Hydrogen Spectroscopy Option - PROBE). No specific quantitative criteria are listed.
   • Reported Device Performance: Stated as "The effectiveness of the system is similar to that of the GE Hydrogen Spectroscopy Option - PROBE (the predicate device)." No specific performance metrics or data are provided.

2. Sample size used for the test set and the data provenance: Not provided. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment for a test set is described.

4. Adjudication method for the test set: Not applicable; no test set or adjudication process 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: No MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone performance study, as typically understood for AI algorithms, is described. The modification is software to enable 'H spectroscopy, implying instrumental performance rather than independent algorithmic performance.

7. The type of ground truth used: Not applicable; no ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned in the context of a performance study.

8. The sample size for the training set: Not applicable; no training set for a machine learning model is mentioned.

9. How the ground truth for the training set was established: Not applicable; no training set is mentioned.

Conclusion:

This 510(k) summary focuses on demonstrating that a software addition to an existing MRI system (Gyrex 2T Prestige) to enable 'H spectroscopy is "substantially equivalent" in safety and effectiveness to predicate devices. It achieves this by arguing that:

• Safety aspects (BoodB/dt, acoustic noise, SAR) are unaffected or equivalent to the predicate.
• Software hazards were minimized by design and testing.
• Effectiveness is similar to the GE Hydrogen Spectroscopy Option - PROBE.

It does not provide details of a new performance study with specific acceptance criteria that the new device had to meet and detailed results quantifying its performance against those criteria. The "study" here is the regulatory submission process itself, where the claim of "similarity" is the main argument for effectiveness.

Ask a specific question about this device