(86 days)
VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures.
VISIUS Wireless Coils produce images of the head and upper C-spine internal structures.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.
The IMRIS VISIUS Wireless Coil 1.5T is a receive-only three channel flexible phased array coil. The 1.5T upper coil has two elements and the lower coil has one element. The 1.5T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 1.5T MRI system.
The IMRIS VISIUS Wireless Coils, 3T is a receive-only three channel flexible phased array coil. The 3T upper coil is has two elements and the lower coil has one element. The 3T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 3T MRI system.
The IMRIS 1.5T/3T VISIUS Wireless Coils balance surgical requirements with the MRI requirements to provide MR imaging in intra-operative and interventional procedures. The coils are used to acquire MR images of the head and upper C-spine during intra-operative finterventional procedures. The IMRIS 1.5T/3T Disposable Coils can also be used as standard diagnostic head coils for diagnostic examinations.
This document is a 510(k) summary for MRI coils, not an AI/ML device submission. Therefore, it does not contain the information requested about acceptance criteria and study designs typically associated with AI/ML device performance evaluation, such as:
- A table of acceptance criteria and reported device performance for an algorithm. Instead, it lists various engineering and safety tests for the hardware.
- Sample sizes for AI algorithm test sets.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC studies for human reader improvement with AI assistance.
- Standalone algorithm performance.
- Ground truth types for AI models.
- Training set sample sizes or how their ground truth was established.
The document describes the VISIUS Wireless Coils, 1.5T/3T, which are hardware components (receive-only phased array coils) for MRI systems. The 510(k) submission establishes their substantial equivalence to predicate devices (IMRIS HC150/HC300 coils) based on their intended use, technological characteristics, and safety and performance testing.
Here's an analysis of the provided text, focusing on what is present in terms of acceptance criteria and the study (testing) conducted for this hardware device:
Acceptance Criteria and Device Performance (Bench Testing/Verification & Validation)
The document lists several tests performed to demonstrate the safety and effectiveness of the device. These tests serve as the "acceptance criteria" for a hardware component, ensuring it meets specified engineering and safety standards.
1. Table of "Acceptance Criteria" (Tests) and "Reported Device Performance" (Outcome):
| Acceptance Criteria (Test Performed) | Reported Device Performance (Outcome) |
|---|---|
| IEC 60601-1 compliance | Passed / Complies |
| IEC 60601-2-33 compliance | Passed / Complies |
| Clinical image comparison | Provided clinical images which demonstrate clinical effectiveness |
| MRI compatibility test (MR image artifacts test) | Tested with acceptable results / Meets product specifications (implicitly, no significant artifacts) |
| MRI compatibility test (MR heating test) | Tested with acceptable results (implicitly, no unsafe heating) |
| Surface heating (normal and single fault conditions) | Tested with acceptable results / Meets product specifications (implicitly, no unsafe heating) |
| Single fault condition unplugged (passive detuning test) | Tested with acceptable results |
| Workflow | Tested with acceptable results (implicitly, seamless integration into workflow) |
| Image Non-Uniformity and SNR (measured per NEMA MS 9-2008) | Measured and reported in accordance with NEMA MS 9-2008 and NEMA MS 6-2008. Tested with acceptable results. |
| Sterilization method validation (ANSI/AAMI/ISO 11135-1:2007) | Validated for a sterility assurance level of 10^-6 |
| Electrical, mechanical, and flammability hazards | Complies with voluntary standards (IEC 60601-1, IEC 60601-2-33, and UL 94) |
Study Information (for a Medical Device Hardware Component):
This document describes a series of non-clinical data (bench testing) and some clinical image comparison as the "study" proving the device meets its criteria for safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each test. For "Clinical image comparison," the number of images or patients is not provided. For NEMA testing, specific phantom data would be used, but the quantity is not detailed.
- Data Provenance: Not explicitly stated. Given IMRIS is a Canadian company and the device is intended for use with Siemens MAGNETOM MRI systems, it's likely testing was conducted in a controlled lab or clinical environment associated with the manufacturer or partner. It's retrospective in the sense that these are pre-market tests, but not "retrospective data" in the AI/ML context of analyzing a pre-existing dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable in the AI/ML sense. Ground truth for this hardware device involves engineering specifications, safety standards, and image quality metrics (like SNR, non-uniformity) which are objectively measured. For the "Clinical image comparison," performance would be assessed by trained physicians, as stated in the indications for use. Their number and specific qualifications are not detailed, but they would be radiologists or other physicians interpreting MRI images.
4. Adjudication Method for the Test Set:
- Not Applicable for hardware testing. This concept applies to human interpretation of data, typically in AI/ML performance evaluation. The "clinical image comparison" would rely on a physician's ability to interpret the images effectively, but no formal adjudication process for a test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No evidence of an MRMC study. This type of study assesses how AI assistance affects human reader performance. As this is a hardware device (MRI coil) and not an AI algorithm, such a study would not be relevant or described in the 510(k) for this product aspect. The focus is on the coil's ability to produce diagnostically usable images.
6. Standalone Performance:
- Standalone (algorithm only) performance is not applicable. This device is a passive hardware component (a receive-only coil). Its "performance" is inherently tied to being used with an MRI system. The NEMA standard measurements (SNR, non-uniformity) are a form of standalone technical performance for the coil's imaging capabilities, but not an "algorithm-only" performance as in AI.
7. Type of Ground Truth Used:
- Engineering Specifications / Objective Measurements: For the majority of tests (IEC standards, heating, electrical, flammability, NEMA image quality metrics), the "ground truth" is defined by compliance to established engineering standards, physical measurements, and performance benchmarks.
- Clinical Efficacy (Implicit): For "clinical image comparison," the ground truth is implicitly the ability of the images produced by the new coils to be diagnostically equivalent or superior to those from the predicate coils, as assessed by trained physicians. This is not "pathology" or "outcomes data" in the typical sense for a diagnostic device, but rather the diagnostic quality of the images themselves.
8. Sample Size for the Training Set:
- Not Applicable. This is a hardware device. It does not involve a training set as an AI/ML model would. The design and manufacturing processes are refined through engineering, prototyping, and testing (V&V), not "training."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no AI/ML training set, this question is irrelevant to the described device.
§ 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.