(48 days)
The NSM-S15 product is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI 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. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use are as follows:
Anatomical Region: Head, Shoulder, Breast, Wrist, Body, Spine, Knee, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, Diffusion weighted imaging, MR Angiography, Imaging processing
Imaging capabilities: Spin Echo (SE and 3D SE), Fast Field Echo (FFE and 3D FFE), Inversion Recovery (IRFFE, IRSE), T1-FFE, T2-FFE, N-FFE (2D and 3D), IR prepared T1-FFE3D, Dual Echo (DE) and Dual Spin Echo (DSE), Dual Fast Field Echo (DFFE), Turbo Spin Echo (TSE, 2D and 3D), Single-shot TSE, Dual Contrast Turbo Spin Echo (DTSE), Driven Equilibrium Turbo Spin Echo, IR TSE T2, Balance Fast Field Echo (B-FFE and 3D B-FFE), Diffusion-Weighted Imaging with DWISE and Fast DWISE, Echo Planar Imaging (EPI)
The NSM-S15 product is a 1.5T superconducting magnet MRI system. The operating software based on Windows XP. The system software is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
The provided text describes a 510(k) submission for the Neusoft NSM-S15 MRI System. The key information regarding acceptance criteria and supporting studies is:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" typically associated with clinical performance metrics of an AI/software device (e.g., sensitivity, specificity, AUC). Instead, the submission focuses on establishing substantial equivalence to predicate devices. The "acceptance criteria" can be inferred as meeting the safety and effectiveness requirements of the predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Performance equivalent to predicate devices | Evaluated for performance and found substantially equivalent to MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154). |
| Biocompatibility equivalent to predicate devices | Evaluated for biocompatibility and found substantially equivalent to MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154). |
| Electrical, mechanical, chemical safety equivalent to predicate devices | Evaluated for electrical, mechanical, chemical safety and found substantially equivalent to MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154). |
| Intended uses align with predicate devices | Intended uses for providing physiological and clinical information, producing transverse, coronal, sagittal, oblique, and curved cross-sectional images of various anatomical regions, reflecting NMR properties, and being useful in diagnosis determination by a trained physician, were found comparable to predicate devices. |
| Technology similar to predicate devices | A 1.5T superconducting magnet MRI system, similar to predicate devices in technology (e.g., Gradient Subsystem, RF Subsystem, image reconstruction, 2D/3D imaging, traditional MRI unit). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable/Not specified.
- Data Provenance: Not applicable.
The submission states, "b. Clinical test: No clinical test conducted." This means no human subjects or patient data (retrospective or prospective) were used for a specific clinical test to evaluate the device's diagnostic performance against a ground truth. The evaluation was primarily non-clinical, focusing on substantial equivalence to existing MRI systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test was conducted with a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test was conducted.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted. The document explicitly states "No clinical test conducted."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is an MRI system (hardware and software), not an AI algorithm that provides standalone diagnostic assessments. Its performance is inherent to its imaging capabilities, which were compared to predicate MRI systems.
7. Type of Ground Truth Used:
Not applicable, as no clinical test was conducted to evaluate diagnostic performance against a specified ground truth. The "ground truth" for this submission would be the established safety and performance characteristics of the predicate MRI devices.
8. Sample Size for the Training Set:
Not applicable. This is an MRI system, not a machine learning algorithm requiring a 'training set' in the typical sense. Its operating software is based on Windows XP and is described as an interactive program for scanning control, image reconstruction, and image/archive management. The "training" in this context refers to the engineering and development of the system to meet its specifications, rather than a data-driven machine learning training process.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reasons as above. The system's functionality is developed and validated through engineering standards and comparison to established MRI technology.
§ 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.