(119 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 healtheare 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 does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria in the way a clinical performance study would for an AI-powered diagnostic device.
Instead, the document is a 510(k) summary for a combined MRDD and PET scanner (uPMR 790), asserting substantial equivalence to a predicate device (GE Healthcare's SIGNA PET/MR, K142098). The focus is on demonstrating that the new device has similar technological characteristics and performs as expected, not on specific diagnostic performance metrics (e.g., sensitivity, specificity) against a clinical ground truth.
Here's what can be inferred from the provided text regarding acceptance and testing:
1. A table of acceptance criteria and the reported device performance:
The document lists various non-clinical standards and tests that were conducted. These standards serve as "acceptance criteria" in the sense that the device must comply with them to be considered safe and effective. The "reported device performance" is a general statement that the device "performs as expected" and the "test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices." No specific quantitative performance metrics like sensitivity, specificity, or AUC are provided as acceptance criteria or results.
| Acceptance Criterion (Standard/Test) | Reported Device Performance (Implied) |
|---|---|
| ES60601-1:2005/(R)2012 (Medical Electrical Equipment - Basic Safety) | Complies (performs as expected) |
| IEC 60601-1-2 Ed. 4.0 2014 (EMC) | Complies (performs as expected) |
| 60601-2-33 Ed. 3.1:2013 (MR Equipment Safety) | Complies (performs as expected) |
| IEC 60825-1 Ed. 2.0 2007-03 (Laser Safety) | Complies (performs as expected) |
| ISO 10993-5 (In Vitro Cytotoxicity) | Complies (performs as expected) |
| ISO 10993-10 (Irritation & Skin Sensitization) | Complies (performs as expected) |
| MS 1-2008(R2014) (SNR in MR Images) | Complies (performs as expected) |
| MS 2-2008(R2014) (2D Geometric Distortion in MR) | Complies (performs as expected) |
| MS 3-2008(R2014) (Image Uniformity in MR) | Complies (performs as expected) |
| MS 4-2010 (Acoustic Noise in MR) | Complies (performs as expected) |
| MS 5-2010 (Slice Thickness in MR) | Complies (performs as expected) |
| MS 6-2008(R2014) (SNR & Uniformity for Single-Channel Coils) | Complies (performs as expected) |
| MS 8-2008 (SAR for MR Systems) | Complies (performs as expected) |
| MS 9-2008(R2014) (Phased Array Coils for MR) | Complies (performs as expected) |
| NEMA NU 2-2012 (PET Performance Measurements) | Complies (performs as expected) |
| Overall Clinical Image Quality | "Sample clinical images were provided to support the ability of uPMR 790 to generate diagnostic quality images." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the "sample clinical images" provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The text only mentions "Sample clinical images were provided."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The phrase "diagnostic quality images" implies expert evaluation, but the number or qualifications of experts are not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified.
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:
This is not an AI-powered diagnostic device, but rather a combined imaging system (PET/MR). Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not conducted. The study is about the performance of the imaging device itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is an imaging device, not an algorithm. The "standalone" performance here refers to the device's ability to produce images according to technical standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical images, the "ground truth" seems to be implied by the assessment of "diagnostic quality images." This would likely involve expert interpretation, but explicit details (like expert consensus, pathology, or outcomes) are not given. For the non-clinical tests, the ground truth is against specific engineering and medical device standards (e.g., NEMA NU 2-2012 for PET performance, NEMA MS series for MR performance).
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm that requires a training set. It is a hardware imaging system.
9. How the ground truth for the training set was established:
Not applicable, as this device is not an AI algorithm.
§ 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.