Ingenia 1.5T and Ingenia 1.5T S R5.2

• K Number: K153324
• Device Name: Ingenia 1.5T and Ingenia 1.5T S R5.2
• Manufacturer: PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
• Date Cleared: 2016-03-22 ( 125 days)
• Product Code: LNH , LNI
• Regulation Number: 892.1000
• Type: Abbreviated
• Panel: RA
• Reference & Predicate Devices: K110151

Intended Use

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. For some studies the use of contrast agents can be essential. Their application is subject to local medico-legal regulations and to their appropriateness to assist the diagnosis and therapy planning as judged by a trained physician.

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.

Device Description

The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature is provided with a 70 cm magnet. 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.

The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature also consolidates separately-cleared novel functionalities, and minor hardware and software changes since the clearance of the currently marketed and predicate device, Ingenia R4 (K110151, 03/22/2011).

Following minor hardware and software changes are covered in this submission:

1. (Hardware) Enhanced Patient Communication User Interface Module, IEC/ISO compliant symbols.
2. (Hardware) New computing platform and peripherals for MR Spectrometer (DDAS).
3. (Software) User Interface layout modifications for scan preparation, sequence planning (geometries and parameters), and data processing and viewing.
4. (Software) Planning on cine images.
5. (Software) SAR related parameters (SED). Pregnancy status related to Normal Mode.
6. (Software) Parameter optimization for the reconstruction algorithms.
7. (Software) Partial NSA algorithm in reconstruction.
8. (Software) AutoVoice, using pre-recorded spoken instructions.
9. (Software) VCG, optimized electrode placement and enhanced algorithm.
10. (Software) ComforTone: mechanical resonance frequency dependent timing adjustments of sequences for lower acoustic noise.
11. Enhanced sequences:
    a. AutoSpair.
    b. TSE flow compensation enhancement.
    c. Optimized 3D TSE flip angle sweeps per anatomy.
    d. ENCASE: 3D encoding.
    e. CardiacQuant: triggered T1 mapping sequence.
    f. pCASL.
    g. DTI enhancements.

AI/ML Overview

The provided text primarily focuses on demonstrating substantial equivalence of the Philips Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria.

However, based on the Summary of Non-Clinical Performance Data and Summary of Clinical Data sections, we can infer some information relevant to acceptance criteria and the "study" conducted.

Here's an attempt to structure the information as requested, drawing conclusions from the provided text where explicit details are not present.

Acceptance Criteria and Device Performance

The document doesn't provide a table of explicit, quantitative acceptance criteria for the device's performance (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). Instead, the acceptance criteria are implicitly tied to demonstrating safety and effectiveness compared to a predicate device, and compliance with various standards.

Acceptance Criterion (Inferred from text)	Reported Device Performance
Safety:
Patient protection against excessive RF exposures (SAR, B1+rms controls)	ScanWise Implant uses existing safety mechanisms to protect the patient against excessive RF exposures (Whole Body and Head SAR, local SAR controls, and display of B1+rms). No modifications relative to the implementation of safety mechanisms relative to the predicate device was required.
Prevention of peripheral nerve stimulation (dB/dt control)	ScanWise Implant extends existing software safety provisions to prevent peripheral nerve stimulation. dB/dt is controlled not to exceed a user-specified value (implying adherence to safety limits).
Compliance with international and FDA-recognized consensus standards (e.g., IEC60601 series, NEMA MS series, ISO 14971)	The proposed device complies with and meets the acceptance criteria of: IEC60601-1 Edition 3 Amendment 1, IEC60601-1-2 Edition 3, IEC60601-1-6 Edition 3 / IEC62366, IEC60601-1-8 Edition 2, IEC60601-2-33 Edition 3 Amendment 1, IEC 62304, NEMA MS-1 2008, NEMA MS-4 2008, NEMA MS-8 2008, ISO 14971 (2007), and the device-specific guidance "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 14 1998".
Effectiveness:
Human Factors Engineering acceptance (for ScanWise Implant feature)	Human Factors Engineering testing was performed in line with FDA's guidance document "Applying Human Factors and Usability Engineering to Optimize Medical Device Design - June 22, 2011", indicating successful evaluation of usability and user interface for the ScanWise Implant feature.
Equivalent imaging capabilities and diagnostic information to predicate 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. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. (Stated as equivalent to predicate, and supported by non-clinical verification/validation).
Adequate for intended use	Non-clinical verification and/or validation tests demonstrate that the proposed device "Meets the acceptance criteria and is adequate for its intended use." (This is a general statement, not specific quantitative metrics).

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document states that "Non-Clinical verification and or validation tests have been performed." and mentions "sample clinical images." However, no specific sample size for a test set (e.g., number of patients, number of images) is provided.
   • Data Provenance: Not specified. Given the lack of a clinical study, the "sample clinical images" were likely used for qualitative assessment during non-clinical validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No clinical study involving expert interpretation for ground truth establishment is described. The device's primary pathway to market is substantial equivalence to a predicate, relying on non-clinical testing and engineering validation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical study with expert adjudication is described.

4. 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, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed Ingenia 1.5T and Ingenia 1.5T S R5.2 with ScanWise Implant feature did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness."
   • The device being cleared is an MR system, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate reader improvement. The "ScanWise Implant" feature is described as enabling an "improved and controlled workflow" for MR Conditional implants, acting as a control mechanism rather than an interpretive AI.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable in the typical sense of an AI algorithm. This is a hardware and software update to an MRI system. The performance evaluated was the system's ability to operate safely and effectively, and to manage parameters for MR Conditional implants, rather than an "algorithm only" diagnostic performance. The text mentions "Parameter optimization for the reconstruction algorithms" and "Partial NSA algorithm in reconstruction" which are standalone algorithms within the system, but their performance isn't quantified in terms of diagnostic metrics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the non-clinical validation, the "ground truth" was implicitly defined by engineering specifications, safety standards, and the performance characteristics of the predicate device. The text doesn't describe pathology-confirmed diagnoses or outcomes data as "ground truth."

7. The sample size for the training set:

   • Not applicable in the context of machine learning training data. This submission describes a new version of an MRI system, not an AI/ML device that requires a distinct training set. The various software enhancements and algorithms mentioned (e.g., parameter optimization for reconstruction, DTI enhancements, ComforTone) were developed and refined through engineering processes, not via a labelled "training set" like a typical AI application.

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7).

Regulation Number and Section

§ 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.