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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.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.