(30 days)
The Ingenia 1.5T and Ingenia 3.0T are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
In addition, the Ingenia 1.5T and Ingenia 3.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.
The 510(k) subject devices are magnetic resonance coil is designed and intended for use with Philips 1.5T & 3.0T Magnetic Resonance Imaging (MRI) systems. The MR Coil devices work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so the coil may receive the resultant RF signal from the excited nuclei. The coil is designed as receive only for high resolution diagnostic imaging of internal body structures.
The provided text is a 510(k) Summary of Safety and Effectiveness for Philips Ingenia MRI coils. It outlines the device description, indications for use, and claims substantial equivalence to a predicate device.
Crucially, this document focuses on demonstrating substantial equivalence based on design similarities and identical indications for use, without presenting data from
clinical performance testing or algorithm-based performance studies.
Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested (i.e., with performance metrics, sample sizes for test/training, expert and ground truth details, MRMC studies, etc.).
The regulatory submission explicitly states:
"The scope of this Special 510(k) is supplemental labeling to allow the MRI coil accessory devices to be packaged and labeled at another facility owned by Philips. There are no changes to the electrical or mechanical design of the MRI coil devices and no changes to the indications for use. The new labeling does not supplant any of the labeling for the MRI system as described in K110151."
This indicates that the submission is a "Special 510(k)" for a change in manufacturing location/labeling, not a submission for a new device requiring extensive performance validation for software or AI components. The MR coils themselves are hardware accessories to an MRI system.
Therefore, I cannot populate the requested table or answer the detailed questions about acceptance criteria verification studies because the provided document does not contain such information for performance metrics.
If this were a typical AI/software device submission, the provided document would be insufficient. The information usually found in such submissions (and required to answer your questions) would include:
- Acceptance Criteria for Performance: Quantifiable metrics (e.g., sensitivity, specificity, AUC, FROC, agreement rates) with predefined thresholds.
- Study Design: Details of a performance study (e.g., diagnostic accuracy study, reader study).
- Test and Training Data Provenance: Sources, characteristics, and acquisition methods of the data.
- Ground Truth Establishment: How the true status of cases was determined (e.g., multi-expert consensus, biopsy, clinical follow-up).
- Expert Qualifications and Adjudication: Details on the radiologists/experts involved in ground truth and study reading.
- Statistical Analysis Plan: Methods for evaluating the results.
In summary, the provided K123492 document is a regulatory submission for a change in manufacturing/labeling of an MRI coil, not a performance study for an AI-based diagnostic device. As such, the requested information on acceptance criteria and proof of performance (in the context of AI/software algorithm evaluation) is not present.
§ 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.