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510(k) Data Aggregation
(65 days)
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
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
| Acceptance Criteria Category | Specific Metric (Software Version 3.0) | Predicate Device Performance | Conclusion (Met/Not Met) |
|---|---|---|---|
| Minimum TE | 2ms | 4.3ms | Met (Improved) |
| Minimum TR | 7ms | 11ms | Met (Improved) |
| Minimum FOV | 4cm | 6.4cm | Met (Improved) |
| Maximum 2D Acquisition Matrix | $1024^2$ | $512^2$ | Met (Improved) |
| Maximum 3D Acquisition Matrix | $256^3$ or 128x512x512 | $256^3$ or 128x512x512 | Met (Equivalent) |
| Maximum Number of Echoes | 8 | 8 | Met (Equivalent) |
| Maximum Number of Slices | 80 | 80 | Met (Equivalent) |
| Minimum Slice Width | 0.5mm | 0.7mm | Met (Improved) |
| Safety (SAR, dB/dt, acoustic noise, Bo) | Same as predicate devices | (Same as predicate devices) | Met (Equivalent) |
| Software Safety Hazards | Minimized by design reviews, code reviews, and testing | (Not explicitly stated for predicate, assumed safe) | Met (Addressed) |
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.
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(66 days)
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
Magnetic Resonance Imaging of small extremity joints.
The modification is the addition of a flexible coil to image the elbow, hand, ankle, foot, and other small extremity joints. The coil is similar in design to the predicate device, a legally marketed Flexible Coil (K944331). The only significant modification is with respect to the frequency for the 2 Tesla model because the predicate device was designed only for 0.5T, 1.0T and 1.5T systems.
Here's an analysis of the provided information, describing the acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) submission for a modification to an existing device, a Flex Coil for MRI systems. As such, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness, rather than meeting specific quantifiable performance metrics for a novel diagnostic algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance and Evidence (Flex Coil) |
|---|---|---|
| Safety | No adverse impact on MRI safety parameters (SAR, dB/dt, Bo, acoustic noise). | * MRI safety parameters (SAR, dB/dt, Bo, acoustic noise) do not apply to passive coils. |
| Avoidance of electric shock hazards. | * Enclosures designed to comply with clause 16 of IEC-601-1 safety standard. | |
| Avoidance of injury from rough surfaces, sharp corners, and edges. | * Design according to clause 23 of the IEC-601-1 standard. | |
| Coil enclosures and protective covers meet flammability standards. | * Flame rated better than CPAI-84. | |
| No software modifications. | * No software modifications have been made. | |
| Patient contacting materials are identical to predicate device. | * All patient contacting materials are identical to those used in the predicate Flexible Coil (K944331). | |
| No impact on site planning, installation, service manuals, or safety labeling. | * Current modifications do not affect site planning, installation, service manuals, and do not require new safety labeling. | |
| Effectiveness | Acceptable uniformity. | * The Elscint 0.5T and 2T Flex Coils have acceptable uniformity. (Specific quantifiable metrics for "acceptable" are not provided in this summary.) |
| Higher Signal-to-Noise Ratio (SNR) compared to the predicate Shoulder Coil. | * The Elscint 0.5T and 2T Flex Coils have higher SNR than the Shoulder Coil. (Specific quantitative SNR values or improvement percentages are not provided.) | |
| Improved image quality compared to the predicate Shoulder Coil. | * The images produced by the Flex Coils are better than those produced using the Shoulder Coils on the same systems. (This is a subjective assessment of image quality, without further detail on how "better" was defined or measured.) | |
| Substantial Equivalence | The device is substantially equivalent to predicate devices in terms of safety and effectiveness, including the frequency specified for the 2 Tesla model. | * The device is "substantially equivalent to the predicate devices in terms of safety and effectiveness," with the specific note that the modification mainly involves the frequency for the 2 Tesla model since the predicate was for 0.5T, 1.0T, and 1.5T. Implicitly, by accepting the 510(k), the FDA agreed with this assessment. |
Study Details Proving Acceptance Criteria
The provided document is a summary of a 510(k) premarket notification. It does not describe a formal scientific "study" in the way one might evaluate a new diagnostic algorithm. Instead, it demonstrates substantial equivalence through a comparison to existing, legally marketed predicate devices and by outlining compliance with relevant safety standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set sample size" or "data provenance" in terms of patient data. The evaluation appears to be based on:
- Engineering Analysis and Compliance: Demonstrating adherence to IEC safety standards.
- Bench Testing/Performance Evaluation: Stating "acceptable uniformity," "higher SNR," and "better images" compared to the Shoulder Coil. This would imply some form of imaging or phantom tests, but no specifics are given regarding the number of images, phantoms, or human subjects used.
- Comparison to Predicate: The primary "test" is a comparison of the modified device's characteristics against those of the predicate devices.
Given the context of a 510(k) for a coil modification, it's highly likely that this involved a limited number of phantom images and possibly images from volunteer subjects, but no large-scale patient study aiming for statistical significance is described.
- Data Provenance: Not specified, but likely internal testing by Elscint. Retrospective or prospective nature is not indicated for any observed performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable in the traditional sense. For a device like a new MRI coil, "ground truth" isn't typically established by expert consensus on clinical diagnoses within a test set. Instead, performance metrics like uniformity and SNR are objectively measured. Subjective "better images" assessment might involve internal engineers or physicists, but the number and qualifications are not specified.
4. Adjudication Method for the Test Set
- Not Applicable. As there's no defined "test set" requiring clinical diagnosis or interpretation, no adjudication method would have been used. Performance metrics like SNR and uniformity are objectively measured characteristics of the coil's physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not done. The effectiveness claims ("higher SNR," "better images") are implicitly based on direct comparison to the predicate shoulder coil, likely through technical specifications or qualitative review, not a formal multi-reader study.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes (Implicitly). The evaluation of the coil's physical performance characteristics (uniformity, SNR) is a standalone assessment of the device hardware. The statement "The Elscint 0.5T and 2T Flex Coils have acceptable uniformity and higher SNR than the Shoulder Coil" indicates a standalone assessment of the coil's imaging capabilities without human interpretation influencing the raw metrics. The claim of "better images" is a subjective standalone assessment.
7. The Type of Ground Truth Used
- For safety: Compliance with international safety standards (IEC-601-1) and material specifications (CPAI-84).
- For effectiveness: Objective physical measurements (e.g., uniformity, SNR, though specific metrics are not provided) and qualitative comparative assessment ("better images") against a predicate device.
8. The Sample Size for the Training Set
- Not Applicable. The device is a hardware component (an MRI coil), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, there is no ground truth established for one.
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(63 days)
GYREX V-EP
Not Found
The Gyrex V-EP is a modification of the Gyrex Privilege system that enables current owners of the Gyrex V-Dlx to upgrade to the Gyrex Privilege without having to replace their existing magnet. The differences between the Gyrex V-EP and the Standard Gyrex Privilege are the size of the magnet, the size of the gradient coils, and the size of the Body Coil. All performance specifications are identical in the two systems.
Here's an analysis of the provided text regarding the Gyrex V-EP device, structured to answer your questions about acceptance criteria and study details. It's important to note that the provided text is a 510(k) summary for a medical device modification, not a detailed clinical study report. Therefore, many of your questions cannot be fully answered with the given information as it pertains to a direct performance study of the Gyrex V-EP itself.
Focus of the Provided Document: The provided text is a 510(k) premarket notification summary. This document's primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a de novo clinical study with detailed performance metrics against pre-defined acceptance criteria for a new clinical indication.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Gyrex V-EP) |
|---|---|
| Safety: | |
| MRI parameters (Bo, SAR, dB/dt, acoustic noise) remain below levels of concern per IEC 601-2-33 final draft. | Bo is the same as predicate. SAR, dB/dt, and acoustic noise have changed but remain below IEC 601-2-33 final draft levels of concern. |
| Gradient coils and Body Coil comply with appropriate safety standards. | Gradient coils and Body Coil comply with appropriate safety standards. |
| Patient-contacting materials are identical to predicate. | Patient-contacting materials are identical to predicate. |
| No new safety hazards related to Site Planning, Installation, and Service. | No new safety hazards related to Site Planning, Installation, and Service introduced. |
| No new requirements for safety-related labeling. | No new requirements for safety-related labeling introduced. |
| Effectiveness/Performance: | |
| Performance specifications are identical to the predicate device (Elscint Gyrex Privilege system, K954039). | Performance specifications are identical to the predicate device. |
2. Sample Size for the Test Set and Data Provenance
Based on the provided 510(k) summary:
- Sample Size: Not applicable in the context of a clinical test set. The document outlines a comparison strategy based on technical specifications and design similarities to the predicate device. It does not describe a clinical evaluation with a test set of patient data for the Gyrex V-EP.
- Data Provenance: Not applicable. The "study" described here is a design comparison and safety analysis rather than a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This document is not describing a study where expert interpretations or ground truth establishment on a test set was performed for the Gyrex V-EP. The "ground truth" for the submission is the performance and safety profile of the predicate device, against which the modifications are compared.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not described. The document focuses on demonstrating substantial equivalence based on technical specifications and safety assessments, not an evaluation of human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Not applicable. The Gyrex V-EP is a hardware modification for a Magnetic Resonance Diagnostic Device. It is not an AI algorithm or software for which a standalone performance study would be conducted in this manner.
7. The Type of Ground Truth Used
- Predicate Device Specifications and Safety Profiles: The "ground truth" implicitly used for this submission is the established safety and effectiveness profile of the predicate device (Elscint Gyrex Privilege system, K954039), along with compliance with relevant engineering standards (e.g., IEC 601-2-33). The Gyrex V-EP's design and performance are asserted to be either the same or within acceptable safety limits compared to the predicate.
8. The Sample Size for the Training Set
- Not applicable. The Gyrex V-EP is a hardware system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
Summary of Device and Evidence Type:
The Gyrex V-EP is an upgrade/modification to an existing MRI system (Gyrex Privilege), allowing current owners of the Gyrex V-Dlx to upgrade without changing their magnet. The core argument for its approval (substantial equivalence) rests on:
- Identical Performance Specifications: The device is stated to have identical imaging performance specifications to the predicate device.
- Safety Assessment of Changes: The changes (magnet size, gradient coils, body coil) were evaluated to ensure they still meet safety standards (SAR, dB/dt, acoustic noise below IEC 601-2-33 limits) and that patient-contacting materials and other safety aspects remain consistent with the predicate.
This 510(k) submission relies on a comparison to a previously cleared device and adherence to engineering safety standards, rather than a new clinical study generating performance metrics from patient data.
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