(134 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 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 Elition S and Ingenia Elition X R5.4 with new gradient system/specifications are modifications of the 70 cm Ingenia 3.0T system, included in the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). The systems and control software are substantially equivalent to the legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). Hereafter Ingenia Elition S and Ingenia Elition X R5.4 will be used to indicate the proposed device Ingenia Elition S and Ingenia Elition X R5.4 with new gradient system/specifications The proposed Ingenia Elition S and Ingenia Elition X R5.4 also includes minor software changes since the clearance of the legally marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (K163116, 01/06/2017). The following modifications are covered compared to legally marketed predicate device: 1. Upgrade of SW platform to Windows 10 and PSC 6.1 (to be compatible with Windows 10); 2. PerformanceBridge Protocol Manager Release 1.0; 3. Introduction of new gradient system hardware with new qradient specifications: 4. Introduction of new product name and covers. The proposed Ingenia Elition S and Ingenia Elition X R5.4 are intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA: 1. mDIXON K102344 2. SWIp K131241 3. mDIXON-Quant K133526 4. MRE K140666 5. mDIXON XD K143128 6. O-MAR K143253 7. MultiBand SENSE K143606 8. Ingenia Coils See Appendix 004
The provided text is a 510(k) summary for the Philips Ingenia Elition S and Ingenia Elition X R5.4 Magnetic Resonance Diagnostic Devices. This document does not describe acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically expected for an AI/algorithm-based device's performance.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3, K163116) through non-clinical performance data and compliance with recognized standards. The "acceptance criteria" referred to in the document are general statements about meeting regulatory and safety standards for an MRDD, rather than specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI algorithm.
Therefore, many sections of your requested output cannot be fulfilled from the provided text.
Here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with international and FDA-recognized consensus standards (e.g., IEC, NEMA, ISO) | The device complies with the listed standards. |
| Meets acceptance criteria and is adequate for its intended use | Non-Clinical verification and validation tests demonstrate that the device meets acceptance criteria and is adequate for its intended use. |
| Substantial equivalence to predicate device in terms of safety and effectiveness | Demonstrated through non-clinical performance (verification and validation) tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document explicitly states: "The proposed Ingenia Elition S and Ingenia Elition X R5.4 did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
- The "test set" in this context refers to non-clinical verification and validation tests, not a dataset of patient images for an algorithm's performance evaluation. No information on sample size or data provenance (country of origin, retrospective/prospective) for such tests is provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. As no clinical study was performed for AI algorithm performance, there's no mention of experts establishing a ground truth for a test set.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical study or performance evaluation with a test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states no clinical study was required. Therefore, an MRMC study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This submission is for an MRI system, not a standalone AI algorithm. The performance evaluation focuses on the safety and effectiveness of the MRI system, not an AI component's standalone diagnostic capabilities.
7. The Type of Ground Truth Used:
- Not Applicable. For the non-clinical verification and validation tests, the "ground truth" would be established by engineering specifications, regulatory standards, and expected physical performance parameters of the MRI system, rather than expert consensus, pathology, or outcomes data related to an algorithm's diagnostic output. The document doesn't detail the specifics of these non-clinical ground truths.
8. The Sample Size for the Training Set:
- Not Applicable. This is not a submission for an AI/ML algorithm that requires a training set. The "software changes" mentioned are minor updates to the operating system and existing functionalities, not the development of a new AI model requiring training data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No AI/ML algorithm requiring a training set is described.
In summary:
This 510(k) submission primarily details the device (an MRI system) modifications and demonstrates substantial equivalence to a previously cleared predicate device through compliance with various non-clinical standards and tests. It does not involve the evaluation of an AI algorithm's diagnostic performance against specific acceptance criteria using patient data, and thus, many of the requested details are not present in this type of regulatory filing.
§ 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.