(27 days)
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan Opera MR 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 relaxation time (T1), spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
The system is composed of these main parts:
- Patient positioning table.
- Magnetic unit with the display panel.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
- Electronics box with filter panel.
- Modular shielding box.
This 510(k) summary (K060956) is for the E-scan Opera, a Magnetic Resonance (MR) diagnostic device. It's important to note that this submission is a Special 510(k), meaning it's for modifications to an already cleared device (E-scan XQ K032121), and the changes do not affect the intended use or alter the fundamental scientific technology of the device.
Therefore, the submission focuses on demonstrating that the modified device remains substantially equivalent to the predicate devices and does not introduce new questions of safety or effectiveness. This type of submission typically relies on a comparison of technological characteristics with predicate devices rather than new clinical performance studies with specific acceptance criteria in the same way a de novo device might.
Based on the provided document, the acceptance criteria and study information typically sought for a new or significantly modified device's performance are not explicitly present or detailed because this is a Special 510(k) for minor modifications to an existing technology. The "study" here is essentially the comparison of technical specifications and demonstrating that the changes do not negatively impact performance or safety.
Here's an attempt to answer your questions based on what's available and the nature of a Special 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
For a Special 510(k) like this, specific "acceptance criteria" and "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not required or presented in the same way as for a new device. The "performance" is inherently demonstrated by showing substantial equivalence to the predicate device, which has already established acceptable clinical performance.
The document highlights the changes and compares the technical characteristics of the E-scan Opera to its predicate devices (E-scan XQ K032121 and G-scan K042236, as well as MAGNETOM Vision K945517 for software features). The "acceptance criteria" are implied to be that these changes do not degrade the performance or safety of the device compared to the predicate, and in some cases, improve user experience (e.g., lower patient table).
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (E-scan Opera) |
|---|---|---|
| Patient Table | Max load capacity >= 200 kg; Removable from magnet; Rotatable section; Washable material; Manual positioning. | Max load-bearing capacity = 200 kg (approx. 440 lb); Fixed height (710 cm) (20cm lower than E-scan XQ); Removable from magnet cavity; One section can be rotated; Washable covering material; Manual positioning; Integrated in overall design. |
| Magnetic Unit Display Panel | Function for displaying real-time sequences for patient positioning (Preview, Abort). | Function of Display Panel is displaying real time sequences for patient positioning. Commands: Preview (begins real-time sequence and displays image on LCD panel), Abort (stops running sequence). (Comment: Unlike G-Scan, E-scan Opera has no motorized movement, so its display panel function is limited to verifying correct centering). |
| Electronics Box & Operating Console | Signals via fiber optic; Console powered by mains. | Signals from electronics box to operating console pass through a fiber optic cable; Operating console powered directly by mains. |
| Electronics Box | Unit to supply display/control panel. | ALDIM unit: supplies the Display Panel. (Comment: Contrasts with G-Scan's ALEL unit which also supplied CCE unit for motorized movement, which E-scan Opera does not have). |
| Software Reconstruction | Reconstruction process on Host/DSP. | Reconstruction process on Host instead of on DSP (same as G-scan K042236). |
| Software RF Saturation | Use of RF saturation pulses to suppress flow/motion artifacts; Pre-saturation regions arbitrarily locatable. | RF saturation pulses are used to suppress flow and motion artifacts. Pre-saturation regions may be arbitrarily located in any orthogonal or oblique orientation (same as MAGNETOM Vision K945517). |
| Software TR Setting | Method to avoid electrical/motion artifacts. | The Repetition Time (TR) of each sequence can be set using fixed step so that 50 or 60 Hz artifacts, caused by external magnetic fluctuation, can be avoided. (Comment: Analogous technique to MAGNETOM Vision's physiological control for heart artifacts, but applied to electrical interference). |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this type of submission. As a Special 510(k) for modifications that do not alter the fundamental scientific technology or intended use, a specific clinical "test set" with a defined sample size for performance evaluation (e.g., diagnostic accuracy) is not typically required or performed. The demonstration of substantial equivalence is based on engineering changes and comparisons to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new clinical performance study requiring expert-established ground truth was detailed in this submission. The device relies on existing MR technology where "medical expert trained in the use of MR equipment" interpret images.
4. Adjudication method for the test set
Not applicable/Not provided. No new clinical performance study requiring adjudication was detailed.
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 applicable. This device is a basic MR imaging system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a basic MR imaging system, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For an MR imaging device, the "ground truth" for diagnostic purposes is typically pathology, surgical findings, or clinical follow-up as interpreted by human experts. However, no new clinical study requiring the establishment of ground truth for performance metrics was conducted or reported in this Special 510(k).
8. The sample size for the training set
Not applicable/Not provided. This submission does not involve a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.
§ 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.