(32 days)
The MR Radiation Oncology Options are a patient positioning package intended for use with the GE wide bore MR scanners. The MR Radiation Oncology Options when used with a GE wide bore MR scanner is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The GE wide bore MR scanners with MR Radiation Oncology Options are indicated for use as a diagnostic imaging device to provide axial, sagittal, coronal, and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE wide bore scanners with MR Radiation Oncology Options reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MR Radiation Oncology Options include a removable patient table insert for GE wide bore MR scanners that allow patients to be imaged on a flat surface. The flat patient surface allows image acquisition in patient positions similar to other modalities that also use a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The GE wide bore MR scanners with the MR Radiation Oncology Options may also be used with MRcompatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.
The MR Radiation Oncology Options includes a radiation therapy insert that can be used with wide bore (70cm) GE MR scanners for radiation therapy planning. The MR Radiation Oncology Options is similar to the existing GE Signa®MR Oncology Package offered with GE Signa®MR Systems. MR Radiation Oncology Options utilizes a radiation therapy table insert that allows patients to be imaged on a flat surface that matches the imaging patient position. The MR Radiation Oncology Options may be used with MR compatible patient positioning accessories and a 3 pin Lok-Bar.
The provided text is a 510(k) Premarket Notification Submission for a medical device called "MR Radiation Oncology Options" by GE Healthcare. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and quantitative results for a new clinical indication.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert qualifications, and ground truth establishment are not present in this type of submission document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific quantitative acceptance criteria or reported device performance metrics are provided in the document in the format requested, as this is a substantial equivalence submission. The primary "acceptance criterion" for this type of submission is demonstrating that the new device is as safe and effective as the predicate device.
The document states:
- "The non-clinical tests outlined above have been executed with acceptable results." (Referring to Risk Analysis, Requirements Reviews, Design Reviews, Subsystem Level Testing, Safety testing).
- "Clinical image comparisons demonstrate that the Radiation Oncology Options maintains the same imaging performance results as the GE Signa® MR Oncology Package with existing patient table."
- "GE Healthcare considers the MR Radiation Oncology Options to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document mentions "Simulated use testing" and "Clinical image comparisons" but does not quantify the number of cases or subjects used for these tests.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. There's no mention of a formal ground truth establishment process involving experts in the context of this submission. The "clinical image comparisons" likely refer to comparing images from the new device with those from the predicate device.
4. Adjudication method for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, What was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. This device is an accessory for patient positioning in MR imaging, not an AI-powered diagnostic tool. The focus is on maintaining imaging performance while offering improved patient positioning features for radiation oncology planning.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical accessory (patient positioning package, table insert) for an MR scanner, not an algorithm.
7. The type of ground truth used:
- The implicit "ground truth" for demonstrating substantial equivalence is the imaging performance and safety of the predicate device (GE Signa® MR Oncology Package, K081916). The comparison is made to show that the new device's images are comparable ("maintains the same imaging performance results") to those of the predicate. This is based on "Clinical image comparisons," but the specific details of how this comparison was qualified are not provided.
8. The sample size for the training set:
- Not applicable. This is a hardware accessory, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this 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.