(32 days)
The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems/Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray, CT, PET and radiation therapy.
The IMRIS MR systems/Siemens MAGNETOM MR Systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.
The IMRIS Oncology Package provides an additional patient tabletop (MR SIMS table top) that can be used with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners for radiation therapy planning. The MR SIMS table top allows patients to be imaged on a flat surface that matches the imaging patient position. The oncology package includes Head and Neck coil (HNC150) and Pelvic coil (PCC 150). Used in the IMRISneuro 1.5Tsystem/Siemens MAGNETOM 1.5 Tesla, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the internal structures of the head, neck and pelvic regions. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The IMRIS HNC150 and PCC150 coils can also be used as standard diagnostic head coils and pelvic coil respectively for diagnostic examinations. The Oncology package may be used with MR-conditional/ MR safe patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: IMRIS Oncology Package (K121997)
This submission is for an IMRIS Oncology Package, which includes an additional patient tabletop (MR SIMS table top), Head and Neck coil (HNC150), and Pelvic coil (PCC150) for use with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners. Its primary intended use is for radiation therapy planning, allowing patients to be imaged on a flat surface similar to other modalities like X-ray, CT, and PET.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes design verification and validation tests (bench testing) rather than specific quantitative "acceptance criteria" against which a statistical performance metric is measured (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on compliance with standards and successful completion of various engineering and clinical image comparison tests.
| Acceptance Criteria Category | Specific Test/Criteria | Reported Device Performance |
|---|---|---|
| Electrical, Mechanical, and Flammability Hazards | IEC 60601-1 compliance | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The oncology package is tested for electrical, mechanical, and flammability hazards. The IMRIS Oncology package complies with voluntary standards (IEC 60601-2-33, and UL 94)." "The tests outlined above have been executed with acceptable results." |
| IEC 60601-2-33 compliance | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The oncology package is tested for electrical, mechanical, and flammability hazards. The IMRIS Oncology package complies with voluntary standards (IEC 60601-2-33, and UL 94)." "The tests outlined above have been executed with acceptable results." | |
| MRI Safety & Performance (Imaging) | MRI compatibility test (MR image artifacts test) | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The HNC 150 and PCC 150 coils are tested for MR image artifacts and surface heating test." "The tests outlined above have been executed with acceptable results." |
| MRI compatibility test (MR heating test / Surface heating (normal and single fault conditions)) | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The HNC 150 and PCC 150 coils are tested for MR image artifacts and surface heating test." "The tests outlined above have been executed with acceptable results." | |
| Single fault condition unplugged (passive detuning test) | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The tests outlined above have been executed with acceptable results." | |
| Head and Neck coil (HNC150) Image Non-Uniformity and SNR Measurement | "SNR was measured and is reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008." "The HNC 150 and PCC 150 coils SNR and Image non-uniformity are tested according to NEMA standards." "The tests outlined above have been executed with acceptable results." | |
| Pelvic coil (PCC150) Image Non-Uniformity and SNR Measurement | "SNR was measured and is reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008." "The HNC 150 and PCC 150 coils SNR and Image non-uniformity are tested according to NEMA standards." "The tests outlined above have been executed with acceptable results." | |
| Clinical Effectiveness / Imaging Quality | Clinical image comparison | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The Oncology Package provided clinical images which demonstrate the clinical effectiveness of the Oncology package." "The tests outlined above have been executed with acceptable results." "Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package." |
| Functional/Workflow | Workflow | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The tests outlined above have been executed with acceptable results." |
| Loading test | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The tests outlined above have been executed with acceptable results." | |
| Overall Safety and Effectiveness / Substantial Equivalence | Compliance with predicate device's intended use and indications for use. | "The IMRIS Oncology Package has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package with the new characteristics." "The IMRIS Oncology Package verification results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate device, GE MR Radiation Oncology options." |
2. Sample size used for the test set and the data provenance
- The document does not specify a numerical sample size for the "clinical image comparison" or other tests.
- Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are described as "Design Verification and Validation Test (Bench Testing)" which suggests these were conducted in a controlled, engineering test environment rather than a large-scale clinical study with real patient data from specific geographical locations. The "clinical image comparison" would likely have involved imaging a small number of volunteers or phantoms, or a small selection of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the summary. For "clinical image comparison," it is implied that a "trained physician" would interpret the images, but the number or specific qualifications for establishing ground truth are not detailed.
4. Adjudication method for the test set
- An adjudication method is not mentioned in the summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study is not described or implied in the provided text. The submission focuses on device safety, performance, and substantial equivalence to a predicate device through bench testing and image quality assessments, not comparative effectiveness with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is an MRI accessory package (tabletop and coils), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this submission. The device produces images that are then interpreted by a trained physician.
7. The type of ground truth used
- For the "clinical image comparison," the ground truth is implicitly expert interpretation by "a trained physician" (as stated in the Indications for Use). For the technical tests (SNR, non-uniformity, artifacts), the "ground truth" would be the NEMA standards themselves and engineering specifications. Pathology or outcomes data are not indicated as ground truth types for this submission.
8. The sample size for the training set
- This device is an MRI accessory package and does not describe an AI algorithm or a "training set" in the context of machine learning. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
- As the device is an MRI accessory package and not an AI algorithm, there is no training set and thus no ground truth established for a training set.
§ 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.