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510(k) Data Aggregation
(60 days)
The Panorama MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Panorama Enhancements, structured according to your request.
Please note: This document describes a submission for a Magnetic Resonance Imaging (MRI) System, specifically "Panorama Enhancements". The information provided is primarily focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study establishing new diagnostic performance metrics for an AI algorithm. Therefore, many of your requested points related to AI performance, ground truth, and expert evaluation are not applicable or extractable from this type of documentation.
Acceptance Criteria and Study for Philips Panorama Enhancements
This submission focuses on demonstrating substantial equivalence of the "Panorama Enhancements" to previously cleared MRI systems (Philips Panorama 0.6T/0.23T and Philips Intera family). The acceptance criteria for this type of submission are primarily related to meeting performance standards and maintaining safety and effectiveness comparable to the predicate devices. The "study" described is essentially a comparison table (Substantial Equivalence Chart) demonstrating how the new enhancements align with or are within the acceptable ranges of the predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an MRI system enhancement, the "acceptance criteria" are implied to be the specifications and performance characteristics of the predicate devices, and the "reported device performance" is how the new "Panorama Enhancements" compare to these predicates.
| Parameter | Acceptance Criteria (Predicate Devices - K013858, K974844, K001796) | Reported Device Performance (Panorama Enhancements - 0.6T MR Imaging System) | Reported Device Performance (Panorama Enhancements - 0.23T MR Imaging System) |
|---|---|---|---|
| Gradient Coils | Water-cooled self-shielded gradient system (K013858, K974844) | Same (Water-cooled self-shielded gradient system) | Same (Water-cooled self-shielded gradient system) |
| Max. Gradient Strength (0.6T) | 20 mT/m (K013858) | 23 mT/m | N/A |
| Max. Gradient Strength (0.23T) | 16 mT/m (x,y direction), 18 mT/m (z direction) (K974844) | N/A | 21 mT/m |
| Max. Slew Rate (0.6T) | 40 T/m/s (K013858) | 75 T/m/s | N/A |
| Max. Slew Rate (0.23T) | 25 T/m/s (x,y direction), 40 T/m/s (z direction) (K974844) | N/A | 50 T/m/s |
| RF amplifiers | Max power 9 kW (K013858) for 0.6T; 5 kW solid state (K013858) for 0.23T | Same (Max power 9 kW) | Same (5 kW solid state) |
| RF transmitter coils | Upper and lower, planar coils, integrated in magnet, water cooling. Tuning adjusted to 0.6T/0.23T field strength (K013858) | Same | Same |
| Receive only RF coils | Head, Head and Neck, Neck, Extremity, Body and Spine, Multipurpose, TMJ, Breast, Shoulder (K013858, K974844, K002539, K981959, K013528, K983143) | Same and Synergy Head and Neck | Same and Synergy Body |
| Magnet Façade | Fiberglass enclosure (K013858, K974844) | New design, cover backdoor of ABS, otherwise material the same. | New design, cover backdoor of ABS, otherwise material the same. |
| Base Software | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability (K013858) | Same | Same |
| MRGP software | Interventional MRI capabilities (K013858) | Same | Same |
| Imaging sequences | Field Echo, Spin Echo, Dual Echo, Dual Spin Echo, Inversion Recovery, Dual Inversion Recovery, Fast Spin Echo, EXPRESS, CBASS, MRCP, MRA, STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE (K013858) | Same | Same |
| Acquisition and reconstruction techniques | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice, MAO, chemical fat saturation, phase conjugate symmetry, read conjugate symmetry, true res, true slice, elliptic encoding, RAM, CODA, MTC, dynamic examination curve, contrast dynamic imaging, reconstruction filters, respiratory gating, multiplanar reconstruction, maximum intensity projection, phase correction, fat/water suppression, ADC map. SENSE capability. SyncraScan (K013858, K001796) | Same | Same |
| User Interface | Layout, see Figure 2a (K013858) | Layout change, see Figure 2b. | Layout change, see Figure 2b. |
| Normal Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 40 T/s (K974844) for 0.23T | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) |
| First Level Controlled Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 60 T/s (K974844) for 0.23T | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) |
| Normal Operating Mode (Radiofrequency Absorption) | Limited to a maximum level of 1.2 W/kg (K013858, K974844) | Same | Same |
| First Level Controlled Operating Mode (Radiofrequency Absorption) | Limited to a maximum value of 3.2 W/kg (K013858, K974844) | Same | Same |
| Acoustic Noise (Typical) | 87 dBA (average) 102 dBA (peak) (K013858) for 0.6T; A-weighted average value < 85 dBA (K974844) for 0.23T | Same | Same |
| Acoustic Noise (Worst Case) | 91 dBA (average), 104 dB (peak) (K013858) for 0.6T; A-weighted average value < 85 dBA, 98 dB peak (K974844) for 0.23T | Same | Same |
| Intended Use and Indications for Use | "NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis." (K013858) | Same, note the system name change. (The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems.) | Same, note the system name change. (The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of an AI/algorithm performance study. The submission is for hardware and software enhancements to an MRI system, demonstrating substantial equivalence to predicate devices based on technical specifications and safety standards. There is no mention of a dataset of patient images being "tested" for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/algorithm performance study requiring expert ground truth establishment for a dataset. The "ground truth" for the device's functionality is its adherence to established MRI performance parameters and safety standards. The interpretation of images for diagnosis is mentioned as being performed by a "trained physician," which is a general statement about the intended use of MRI and not specific to a study assessing device performance against expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring 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
Not applicable. This is not an MRMC study and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes enhancements to an MRI system, which is a diagnostic tool, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of submission, "ground truth" is measured against established engineering specifications, safety standards (like IEC 60601-2-33), and the documented performance characteristics of predicate devices. The device's "performance" is in its ability to generate images with specific physical parameters, not in interpreting those images for a diagnosis.
8. The sample size for the training set
Not applicable. No training set for an AI algorithm is mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI algorithm is mentioned or implied.
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