(60 days)
This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities.
Magnetic Resonance images represent 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. The image acquisition process can be synchronized with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images.
Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent.
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 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features are provided with a 70 cm magnet. The system and its control software are substantially equivalent to the currently marketed and primary predicate device Ingenia R4 (K110151, 03/22/2011), combined with the ScanWise Implant feature and other minor changes as in the currently marketed and reference device Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324, 03/22/2016).
ScanWise Implant functionality enables MR technologists to implement an improved and controlled workflow for MR Conditional implants. The feature consists of an extension to the Patient Registration User Interface where the information relevant to MR Conditional device labeling can be assessed, controlled and reviewed. The ScanWise Implant feature allows the user at the examination level to define restrictions on the 'active fields' generated by the MR system.
3D ASL functionality enables MR technologists to assess perfusion in the brain without the usage of contrast agents. The feature consists of an extension to the available scan sequences and image reconstruction algorithms.
The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features also consolidate separately-cleared novel functionalities, and minor hardware and software changes since the clearance of the currently marketed and primary predicate device, Ingenia R4 (K110151, 03/22/2011).
Following minor hardware and software changes are covered in this submission:
- Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols.
- New computing platform and peripherals for MR Spectrometer (DDAS).
- Planning on cine images.
- SAR related parameters (SED). Pregnancy status related to Normal Mode.
- SED limit
- Parameter optimization for the reconstruction algorithms.
- Partial NSA algorithm in reconstruction.
- AutoVoice, using pre-recorded spoken instructions.
- VCG, optimized electrode placement and enhanced algorithm.
- ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise.
- Enhanced sequences:
a. LIPO
b. Black Blood Imaging
c. 4D TRAK XD
d. Zoom Diffusion Imaging
e. 3D Vane XD
f. 4D TRANCE
g. 3D NerveVIEW
h. Fast B1 Mapping and B1 Shading filter
i. AutoSpair.
j. TSE flow compensation enhancement
k. Optimized 3D TSE flip angle sweeps per anatomy
l. ENCASE: 3D encoding
m. CardiacQuant: triggered T1 mapping sequence
n. pCASL
o. DTI enhancements
p. QA Tool and fMRI stability
The provided text describes a 510(k) summary for the Philips Ingenia 1.5T, Ingenia 1.5T S, and Ingenia 3.0T R5.3 MR systems, which includes new features like ScanWise Implant and 3D ASL. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study for novel AI/software performance. Therefore, many of the requested criteria regarding AI performance studies cannot be fully addressed from the given text.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device complies with a list of international and FDA-recognized consensus standards and a device-specific guidance document. The acceptance criterion is that the device "Meets the acceptance criteria and is adequate for its intended use" as defined by these standards and guidance. The reported performance is that the device does meet these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with IEC60601-1 Ed 3 Am 1, IEC60601-1-2 Ed 3, IEC60601-1-6 Ed 3 / IEC62366, IEC60601-1-8 Ed 2, IEC60601-2-33 Ed 3 Am 1, IEC 62304, NEMA MS-1 2008, NEMA MS-4 2008, NEMA MS-8 2008, NEMA PS 3.1-PS 3.20 - [DICOM], ISO 14971 (2007), and "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14, 1998". | Non-Clinical verification and/or validation tests have been performed demonstrating compliance with all aforementioned international and FDA-recognized consensus standards and the device-specific guidance document. "The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features [...] Complies with the aforementioned international and FDA-recognized consensus standards and Device specific guidance document..." |
| Adequacy for intended use. | "The verification and or validation test results, combined with sample clinical images demonstrate that the proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features: ...Meets the acceptance criteria and is adequate for its intended use." This conclusion supports the substantial equivalence claim. |
| ScanWise Implant functionality for an improved and controlled workflow for MR Conditional implants. | Human Factors Engineering testing was performed for ScanWise Implant. The feature enables MR technologists to implement an improved and controlled workflow for MR Conditional implants by providing a user interface to assess, control, and review information relevant to MR Conditional device labeling and define restrictions on active fields. It extends existing software safety provisions to prevent peripheral nerve stimulation, and dB/dt is controlled not to exceed a user-specified value. |
| 3D ASL functionality for assessing perfusion in the brain without contrast agents. | 3D ASL is an extension to the previously cleared pCASL functionality, allowing users to perform ASL perfusion studies according to international recommendations which include 3D acquisition. The functionality consists of an extension to available scan sequences and image reconstruction algorithms. The non-clinical tests confirmed its adequacy. |
2. Sample size used for the test set and the data provenance
The document mentions "sample clinical images" were used in combination with verification and validation test results. However, it does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature). The submission emphasizes non-clinical performance and states that a clinical study was not required.
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 document. The submission focuses on non-clinical testing and substantial equivalence, not a clinical reader study with a ground truth established by experts.
4. Adjudication method for the test set
This information is not provided as no formal clinical reader study with adjudication is described.
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
No MRMC comparative effectiveness study was done, according to the provided text. The document explicitly states: "The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 with ScanWise Implant and 3D ASL features did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated..."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes ScanWise Implant as functionality that "enables MR technologists to implement an improved and controlled workflow" and "allows the user at the examination level to define restrictions." Similarly, 3D ASL is a feature that "enables MR technologists to assess perfusion." These descriptions imply human-in-the-loop use. There is no mention of a standalone algorithm-only performance study unrelated to human interaction or interpretation. The core device itself is a diagnostic imaging system, which inherently requires a trained physician for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail a "ground truth" in the context of a clinical study or diagnostic accuracy assessment. Instead, it relies on verification and validation testing against defined engineering requirements and regulatory standards. For ScanWise Implant, "Human Factors Engineering testing" was performed, which assesses usability, not diagnostic ground truth. For 3D ASL, the claim is about "assessing perfusion in the brain without the usage of contrast agents," implying the capability of the sequence to generate perfusion images, which would then be interpreted by a physician.
8. The sample size for the training set
This information is not applicable/not provided. The document describes upgrades and new features for a Magnetic Resonance Diagnostic Device, not an AI/ML algorithm that would undergo a separate "training" phase in the computational sense. The "ScanWise Implant" and "3D ASL" features are described as extensions to existing software and scan sequences, implying development and validation against established engineering principles and standards, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as 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.