(141 days)
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied, and presence of contrast agents. The use of contrast imaging applications should be performed consistent with the approved labeling for the contrast agent.
The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.
The systems can use combinations of images to produce physical parameters, and related derived images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assust diagnosis, and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user.
In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems R12 are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems.
This bundled abbreviated 510(k) submission, is prompted by the introduction of a new optional software feature called Precise Image contained in software R12 for the proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems, as compared to our legally marketed primary predicate device Achieva, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (R11) (K213583) and the secondary predicate device MR 5300 and MR 7700 R11 MR Systems (K223442).
Precise Image is a deep learning based reconstruction technique designed to increase signal-to-noise ratio (SNR), increase sharpness and decrease ringing artefacts from MR images.
The introduction of Precise Image only required updates to the MR System Software.
The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems are intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA:
- mDIXON (K102344)
- SWIp (K131241)
- mDIXON-Quant (K133526)
- MRE (K140666)
- mDIXON XD (K143128)
- O-MAR (K143253)
- 3D APT (K172920)
- Compatible System Coils
The accessories to be used with the proposed device Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems have not changed compared to the primary predicate device and secondary predicate device and can be found in the Instructions for Use accompanying the device:
System coils PPU Sensor for wireless physiology Pediatric PPU Sensor FlexTrak trolleys (FlexTrak / HA FlexTrak II) Acoustic Hood MR Elastography
When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply:
Flextrak OR MR-RT CouchTop RT CouchTop XD
The provided text describes the acceptance criteria and the study conducted for the Philips Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300, and MR 7700 MR Systems, specifically focusing on the new "Precise Image" software feature.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain equivalence for diagnosis | Assessed as equivalent for diagnosis compared to predicate reconstruction technology |
| Improve Signal-to-Noise Ratio (SNR) | Significantly better SNR compared to predicate reconstruction technology |
| Improve sharpness | Significantly better sharpness compared to predicate reconstruction technology |
| Manage artifact level | Artifact levels were analyzed |
| Manage contrast-to-noise ratio (CNR) | CNR was analyzed |
| Maintain quality of visualization of abnormalities and pathologies | Assessed as equivalent for diagnosis and showed significantly better SNR and sharpness in the presence of (subtle) abnormalities and pathology. |
| Sufficient quality for diagnostic purposes | Images were assessed to be of sufficient quality for diagnostic purposes. |
| Reproducibility of Precise in comparison to predicate device reconstruction technique | Considered established. |
2. Sample size used for the test set and the data provenance
The document mentions "a reader evaluation by ABR board certified radiologists was performed" and refers to "MR images," but does not explicitly state the sample size (number of images or cases) used for the test set. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states "ABR board certified radiologists" were used for the reader evaluation. It does not specify the exact number of experts or their years of experience.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify the adjudication method used for the reader evaluation. It only mentions that radiologists performed the evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
The study was a reader evaluation comparing MR images reconstructed with the new "Precise Image" feature (deep learning-based) to images from the predicate device reconstruction technology. While it involved multiple readers (radiologists) and multiple cases (implied by "MR images" and "abnormalities and pathologies"), it was primarily an evaluation of the image quality and diagnostic equivalence of the algorithm's output rather than a direct MRMC comparative effectiveness study measuring human reader improvement with AI assistance versus without.
Therefore, the document does not provide an effect size of how much human readers improve with AI vs without AI assistance. The focus was on the performance of the algorithm's output itself in comparison to existing technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone evaluation was implicitly done through the "reader evaluation by ABR board certified radiologists." The radiologists assessed the properties of the images generated by the new Precise Image technique against images from the predicate reconstruction technology. This assesses the algorithm's output quality and diagnostic value in a standalone capacity, even though humans are interpreting its output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the reader evaluation seems to be based on expert assessment/consensus by the ABR board-certified radiologists, who evaluated image properties (SNR, artifact level, sharpness, CNR) and the visualization of abnormalities/pathologies. The document doesn't explicitly mention external pathology or outcomes data as the primary ground truth for this specific evaluation, rather the expert interpretation of the images.
8. The sample size for the training set
The document does not mention the sample size used for the training set of the deep learning-based "Precise Image" reconstruction technique.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set was established for the deep learning-based "Precise Image" technique. It only describes the nature of the technique as "deep learning based reconstruction."
§ 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.