(20 days)
The InVision™ 3T Recharge Operating Suite is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The InVision™ 3T Recharge Operating Suite may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The InVision™ 3T Recharge Operating Suite may also be used for imaging in a multi-room suite.
The proposed InVision™ 3T Recharge Operating Suite featuring the Siemens MAGNETOM Skyra Fit upgrade from Verio is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision™ 3T Recharge Operating Suite uses a scanner, the Siemens MAGNETOM Skyra Fit (K220589, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 3T MAGNETOM Skyra Fit MRI scanner is an actively shielded magnet with a magnetic field strength of 3 Tesla.
The InVision™ 3T Recharge Operating Suite provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure. Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Skyra Fit MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI.
The provided FDA 510(k) Clearance Letter states that the "InVision™ 3T Recharge Operating Suite" has been tested and determined to be substantially equivalent to the predicate device "IMRIS iMRI 3T V (K212367)". However, the document does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), or details of a de novo study proving the device meets said criteria.
Instead, the document focuses on demonstrating substantial equivalence through:
- Comparison of indications for use, principles of operation, and technological characteristics.
- Conformity to FDA recognized consensus standards.
- Successful completion of non-clinical performance, electrical, mechanical, structural, electromagnetic compatibility, and software testing.
- Successful completion of standard Siemens QA tests and expert review of sample clinical images to assess clinically acceptable MR imaging performance.
Therefore, many of the requested details about acceptance criteria and a specific study proving those criteria are not present in this document. The device is a "Magnetic resonance diagnostic device" (MRDD), implying its performance is related to image quality and ability to assist in diagnosis, but quantitative metrics are not provided.
Here is a summary of the information that can be extracted or inferred from the provided text, with blank or "N/A" for information not present:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not specify quantitative acceptance criteria or reported device performance metrics in terms of clinical diagnostic efficacy (e.g., sensitivity, specificity, accuracy). The acceptance is based on demonstrating substantial equivalence to a predicate device and successful completion of various engineering and functional tests.
| Acceptance Criteria (Not explicitly stated in quantitative terms; inferred from substantial equivalence) | Reported Device Performance (Not explicitly stated in quantitative terms) |
|---|---|
| - Substantially equivalent Indications for Use | Same as predicate device (stated in "Equivalence Comparison" columns) |
| - Substantially equivalent Principles of Operation | Same as predicate device |
| - Substantially equivalent Technological Characteristics (with differences validated) | Differences in Siemens MRI scanner, magnet mover, and software. Validation data supports equivalent safety and performance profile. |
| - Conformity to FDA recognized consensus standards (e.g., for safety, EMC, software) | Conforms to listed standards (Table 2) |
| - Performance equivalent to predicate device for intraoperative features | Equivalence demonstrated through testing, no new safety/effectiveness issues. |
| - Clinically acceptable MR imaging performance in DR and OR | Demonstrated through standard Siemens QA tests and expert review of sample clinical images. |
| - Passed non-clinical testing (functional, imaging, integration, software, acoustic, heating) | Successful completion of all listed non-clinical tests (Table 3) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "Sample Clinical Images in DR and OR" were assessed, but the number of images or cases is not given.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. The document mentions "expert review of sample clinical images."
- Qualifications of Experts: It states "interpreted by a trained physician" in the Indications for Use, and mentions "expert review" for image assessment, but specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document states "expert review of sample clinical images," but does not detail how consensus or adjudication was reached if multiple experts were involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence via engineering/functional performance and image quality, not directly on reader performance with/without AI assistance.
- Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable, as no MRMC study involving AI assistance was described. The device itself is an MRI system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
- Standalone Study: Yes, in a way. The "system imaging performance testing" and successful completion of "standard Siemens QA tests" would represent standalone performance assessments of the MRI hardware and integrated software components responsible for image acquisition, without human interpretation in the loop for the performance assessment itself. However, the primary purpose of the device is to produce images "interpreted by a trained physician," meaning human-in-the-loop is part of its intended use. The document does not describe an "algorithm only" study in the context of an AI-driven diagnostic algorithm.
7. Type of Ground Truth Used
- Ground Truth Type: For the "Sample Clinical Images," the ground truth establishment method is not detailed beyond "expert review." For the general device functionality and image quality, the "ground truth" would be established by engineering specifications, recognized standards, and the performance of the predicate device.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes the clearance of an MRI system, not an AI/ML algorithm that typically requires a discrete "training set." The software components mentioned (Magnet Mover Software and Application Platform Software) likely underwent standard software verification and validation, but not in the context of a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable (see point 8).
§ 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.