(24 days)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
The changes performed on the modified G-scan Brio, with respect to the cleared version – G-scan Brio K161973 – are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- A new Software version (EVO'17) including the following features:
- o New software feature Q-Spine (Quantitative Spine)
- o New software feature 3D Viewer
- o The availability of the E-MRI viewer eXP, the software used as an extension on PC.
Esaote has decided to develop and release an upgrade for software EVO. The EVO'17 includes two new features Q-Spine and 3D Viewer. The function Q-Spine has been already cleared by FDA under the name OrthoCAD System via K120288. The function 3D Viewer has been already cleared by FDA under the name 3Viseon/Surgery via K072653. E-MRI viewer eXP, the software used as an extension on PC, is equivalent to E-MRI Brio Viewer, which is currently available on the G-Scan Brio MRI systems, cleared via K161973.
The provided 510(k) summary for the G-scan Brio device does not include any acceptance criteria or a study demonstrating the device meets such criteria related to its imaging performance or diagnostic accuracy.
Instead, this submission (K180592) focuses on a software upgrade for an already cleared MRI system (G-scan Brio K161973). The upgrades consist of new software features (Q-Spine, 3D Viewer, and E-MRI viewer eXP), which are stated to have been previously cleared under separate 510(k)s (K120288 and K072653) or are equivalent to existing functionalities.
Therefore, the submission relies on the substantial equivalence of these software modifications and the underlying MRI hardware to previously cleared devices.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Imaging Performance / Diagnostic Accuracy | Not provided in the document. The submission does not define specific imaging performance metrics or diagnostic accuracy thresholds for the G-scan Brio or its new software features. | Not provided in the document. No performance data related to imaging quality or diagnostic accuracy is presented. |
| Safety Standards | Conformance to: IEC 60601-1 IEC 60601-1-2 IEC 60601-1-6 IEC 60601-2-33 ISO 14971 ISO 62304 IEC 62366 NEMA MS-1 NEMA MS-3 | The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate and conforms to applicable medical device safety and performance standards. (General statement without specific data) |
2. Sample size used for the test set and the data provenance
- No test set or clinical data is presented for this 510(k) submission. The document explicitly states: "No clinical tests are included within this submission." The submission relies on non-clinical testing (safety standards, software verification) and the substantial equivalence to previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set was used in this submission.
4. Adjudication method for the test set
- Not applicable. No clinical test set was used in this submission.
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 and no AI components are described beyond standard image processing features. The software features (Q-Spine, 3D Viewer) are presented as tools for display, analysis, and comparison, not as AI systems for diagnosis or reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an MRI system, not a standalone algorithm. The software features are enhancements to the MRI system for image display and analysis, to be interpreted by a medical expert. Their performance is described as "equivalent" or relying on previous clearances, not as standalone algorithm performance.
7. The type of ground truth used
- Not applicable. No clinical data was used in this submission. For the non-clinical testing, conformance to safety standards is the "ground truth" for those specific aspects.
8. The sample size for the training set
- Not applicable. No training set data is presented for this submission as it's not an AI/ML device relying on such for its core function.
9. How the ground truth for the training set was established
- Not applicable. No training set data is presented for this submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which, in this case, are primarily related to safety standards and substantial equivalence) consists of non-clinical testing and referencing prior 510(k) clearances.
- Non-Clinical Testing: The manufacturer conducted non-clinical tests to demonstrate compliance with various international and national standards for medical electrical equipment, risk management, and software verification (e.g., IEC 60601-1, ISO 14971, ISO 62304, NEMA MS-1, NEMA MS-3). The submission states that the device "has been found to conform" to these standards.
- Substantial Equivalence Argument: The core of the "proof" for the G-scan Brio's updated software lies in the argument of substantial equivalence to predicate and reference devices.
- The updated G-scan Brio (K180592) is compared to the cleared G-scan Brio K161973.
- New software features Q-Spine and 3D Viewer are stated to have been "already cleared by FDA" under K120288 (OrthoCAD System) and K072653 (3Viseon/Surgery) respectively.
- The E-MRI viewer eXP is considered "equivalent to E-MRI Brio Viewer," which is available on the G-Scan Brio MRI systems cleared via K161973.
Conclusion stated in the document: "The non-clinical testing demonstrates that the G-scan Brio is as safe, as effective, and performs as well as or better than the predicate. G-scan Brio is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards."
In essence, this 510(k) relies on regulatory precedent and adherence to recognized safety standards rather than a de novo clinical study with specific performance acceptance criteria for diagnostic capability.
§ 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.