(248 days)
SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis. The MRI system is composed of magnet, RF Amplifier, Gradient Amplifier, RF Coils, control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP operating system is an interactive program with user friendly interface.
The document describes the SuperVan 1.5T Magnetic Resonance Imaging System, which produces cross-section images of the internal structure of the whole body. The images reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance, and the NMR properties such as proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. These images, when interpreted by a trained physician, assist in diagnosis.
The study presented is to demonstrate that the proposed device, SuperVan 1.5T, is Substantially Equivalent (SE) to a predicate device, ACHIEVA 1.5T & INTERA 1.5T family (K052013), as per FDA requirements for 510(k) premarket notification. This type of submission focuses on comparing the proposed device to a legally marketed predicate device rather than on presenting de novo performance criteria with specific numerical targets.
Since it's a substantial equivalence submission for an MRI system, the "acceptance criteria" are primarily established through compliance with recognized international and national standards for medical electrical equipment and MR imaging performance, and direct comparison of technical specifications with the predicate device.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by conforming to existing standards and demonstrating similar technical characteristics to the predicate device. There are no specific numerical performance metrics (like sensitivity, specificity, accuracy) for disease detection or diagnosis provided in this summary. Instead, the performance is demonstrated by compliance with standards that ensure the device operates safely and produces images of sufficient quality for diagnostic purposes, comparable to the predicate device.
| Item | Acceptance Criteria (Demonstrated by) | Reported Device Performance |
|---|---|---|
| Product Code | LNH (Same as predicate) | LNH |
| Regulation No. | 21 CFR 892.1000 (Same as predicate) | 21 CFR 892.1000 |
| Class | Class II (Same as predicate) | Class II |
| Intended Use | Similar to predicate device (MRI system producing images for diagnosis by a trained physician) | SuperVan 1.5T Magnetic Resonance Imaging System produces transversal, sagittal and coronal and oblique cross-section images of internal body structure, reflecting proton density, T1, T2, and flow, to assist in diagnosis. |
| Installation Type | Fixed (Same as predicate) | Fixed |
| Magnet Type | Super-conducting (Same as predicate) | Super-conducting |
| Field Strength | 1.5T (Same as predicate) | 1.5T |
| Coil | Similar to predicate device | Head coil, neck coil, body coil, knee coil |
| Electrical Safety | Conforms to IEC 60601-1 and IEC 60601-2-33 | Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-2-33:2002 + A1:2005 + A2:2007 |
| EMC | Conforms to IEC 60601-1-2 | Conforms to IEC 60601-1-2: 2007 |
| Patient Contact Material | Similar to predicate | Synthetic resin, Acrylic acid lacquer |
| Biocompatibility | Conforms to ISO 10993 series standards | Conforms to the requirements of ISO 10993 series standards |
| Label and Labeling | Conforms to FDA Regulatory Requirements | Conforms to FDA Regulatory Requirements |
| Level of Concern of Software | Moderate (Same as predicate) | Moderate |
| Image Quality Parameters (SNR, Geometric Distortion, Uniformity, Slice Thickness, Acoustic Noise, SAR) | Conforms to NEMA MS standards | Conforms to NEMA MS 1, 2, 3, 4, 5, 6, 8 standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The non-clinical tests conducted relate to engineering specifications and compliance with standards. These tests typically involve phantoms and engineering measurements, not patient data for establishing a conventional "test set" like in AI/CADe device evaluations. The data provenance would be from laboratory testing and engineering measurements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission focuses on the technical and safety aspects of the MRI system itself, primarily through compliance with engineering standards and comparison with a predicate device. It does not involve a diagnostic performance study with a "ground truth" established by medical experts on a set of images for the device's diagnostic output. The "ground truth" for the device's output is expected to be interpreted by "trained physicians" in clinical use, which is mentioned in the intended use statement.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a diagnostic performance test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/CADe device. It is a Magnetic Resonance Imaging System, a hardware and software system used to acquire images. The study presented here is a substantial equivalence claim based on technical specifications and adherence to standards, not a comparative effectiveness study involving human readers and AI assistance for diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-only device. It is a complete MRI system.
7. The Type of Ground Truth Used
The ground truth here is established by compliance with recognized engineering and safety standards (IEC, ISO, NEMA) for medical devices and MRI systems. For image quality parameters (like SNR, geometric distortion, uniformity, etc.), the "ground truth" would be the specified values or ranges defined in these standards.
8. The Sample Size for the Training Set
Not applicable. The document does not describe a machine learning algorithm that requires a "training set" of data for its diagnostic performance. The software mentioned (AnkeStation) is described as an "interactive program with user friendly interface" for controlling the MRI system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning algorithm described.
§ 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.