(63 days)
The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures.
Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration).
MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.
The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419.
The modifications, do not affect the intended use or alter the fundamental scientific technology of the device.
The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the
• LSDWI sequence for brain examination
-
· MR Angiography
· Maximum Intensity Projection (MIP) -
and to support:
· Additional multi-channel technology coil for body -
· Enhancement of PC board with new processor
Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.
The provided text indicates that the device in question is the Magnifico Open (100009900) and Magnifico MSK (100009910) MRI systems, specifically focusing on the new EVO 23 software release.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and qualitative conclusions. The reported device performance is described as meeting these criteria.
| Acceptance Criteria Category | Reported Device Performance (Conclusion from Study) |
|---|---|
| Software Verification and Validation | Activities were provided. |
| Bench Testing Outputs for New Features (LSDW, MRA, MIP) | Outputs were provided and deemed acceptable. |
| Image Quality Test | Tests were conducted and deemed acceptable. |
| Relevant Electromagnetic Compatibility Tests | Tests were conducted and deemed acceptable. |
| Surface Heating Testing | Tests were conducted and deemed acceptable. |
| Relevant Performance Tests for the Body Coil | Tests were conducted and deemed acceptable. |
| Diagnostic Quality of Sample Clinical Images (for new features) | Reviewed by an ACR registered radiologist and determined to be of good diagnostic quality. |
| Substantial Equivalence Determination | The Magnifico MRI system with EVO 23 Software release is substantially equivalent to the predicate device and conforms to applicable medical device safety and performance requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set. It mentions "Sample clinical images for the new features were reviewed."
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One expert.
- Qualifications: An "ACR registered radiologist." The document does not specify their years of experience.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated as a formal process like 2+1 or 3+1. Given that only one expert (an ACR registered radiologist) reviewed the sample clinical images for new features, it appears to be a single-reader review rather than a consensus or adjudicated process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided text. The study focuses on the substantial equivalence of the device itself and the diagnostic quality of its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device is an MRI system, not an AI algorithm performing diagnostic tasks independently. The "software" modifications refer to new sequences (LSDWI, MR Angiography) and features (MIP), which are integrated into the MRI system to produce images, and these images are then assessed by a human expert. Therefore, a standalone algorithm-only performance study in the context of diagnostic AI is not applicable here. The software verification and validation, along with image quality tests, implicitly evaluate the system's standalone performance in generating medically relevant images.
7. The Type of Ground Truth Used
The ground truth for evaluating the "diagnostic quality" of the sample clinical images for new features was expert consensus/opinion. Specifically, it was the opinion of a single "ACR registered radiologist."
8. The Sample Size for the Training Set
The document does not provide any information about a training set since the device is an MRI system with new imaging sequences and features, not a machine learning model that requires a distinct training phase. The software changes involve implementation of established imaging techniques and display methods.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned or applicable in the context of the described device and its modifications, this information is not provided.
§ 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.