(55 days)
The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/ or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet. RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.
The provided text is a 510(k) summary for the uPMR 790, a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. This document describes the device, its intended use, and the modifications made from a previously cleared predicate device (K183014).
Based on the provided information, the 510(k) pertains to modifications of an existing device and does not describe a study involving detailed acceptance criteria and performance metrics for an AI/algorithm-driven device in the manner requested.
Here's a breakdown of why and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The document describes a device modification and its non-clinical testing. It does not present specific acceptance criteria in terms of accuracy, sensitivity, specificity, or other performance metrics for an AI or algorithm, nor does it report the device's performance against such criteria. The testing focused on demonstrating that the modified hardware (magnet, PET gantry, coils) maintains the expected functionality and safety of the device.
Reasons for Not Applicable:
- The 510(k) is for a combined MR/PET imaging system (hardware), not an AI/software diagnostic tool.
- The "performance data" section focuses on hardware-related tests (e.g., NEMA NU 2 for PET, Signal to Noise Ratio, Geometric Distortion, Magnetic Field Homogeneity for MR) to ensure the modified device functions similarly to its predicate. These are engineering specifications, not clinical performance metrics for an algorithm's diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable for AI/algorithm performance. The document states, "No clinical testing was conducted on the proposed devices." The non-clinical testing involved hardware measurements and phantom studies, not a test set of patient data to evaluate an algorithm's diagnostic performance.
- Data Provenance: Not applicable as there was no clinical testing on data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. Since no clinical testing was conducted on patient data, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method:
- Not Applicable. No clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "No clinical testing was conducted on the proposed devices." Therefore, no MRMC study was performed.
6. Standalone Performance Study:
- No. The document explicitly states: "No clinical testing was conducted on the proposed devices." This implies no standalone (algorithm-only) performance testing on clinical data was performed either. The focus was on hardware modifications.
7. Type of Ground Truth Used:
- Not Applicable for AI/algorithm performance. As no clinical testing was performed, no ground truth from pathology, outcomes data, or expert consensus was used to evaluate an algorithm's performance. The "ground truth" in the context of the non-clinical testing would be the expected physical or electrical properties of the system, measured via phantoms and engineering tests.
8. Sample Size for the Training Set:
- Not Applicable. There is no mention of an AI/machine learning algorithm within the scope of this 510(k) that would require a training set. The device is a medical imaging hardware system.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no training set for an AI/ML algorithm is mentioned, this information is not provided.
Summary of what the document does provide:
The document focuses on demonstrating substantial equivalence of a modified MR/PET imaging system (uPMR 790) to its predicate device (also uPMR 790, K183014) based on hardware changes. The modifications include:
- Introduction of a new magnet.
- Change in the PET gantry structure and RF shield.
- Introduction of six new receive coils and re-categorization of existing coils.
The non-clinical testing performed ensured that these hardware changes did not negatively impact the device's fundamental safety and performance characteristics, such as:
- Electrical safety (IEC 60601-1, -1-2, -2-33).
- PET performance measurements (NEMA NU 2).
- MR imaging quality (Signal to Noise Ratio, Geometric Distortion, Image Uniformity, Magnetic Field Homogeneity, Magnetic Field Decay).
- PET/MR Attenuation Correction.
- Acoustic Noise.
- Surface Heating of RF Receive Coils.
The conclusion is that the modified device remains substantially equivalent to the predicate, and introduces no new indications for use, technological characteristics, or potential hazards/safety risks.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.