(270 days)
The uMI 780 PET/CT is a diagnostic imaging system that combines two existing imaging modalities -PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration of PET and CT images provides anatomical reference for the findings in the PET images.
This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
The uMI 780 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy. The PET system has time-of-flight capability with a timing resolution of 520ps. It has a 300mm-long axial field of view (FoV) and a system sensitivity higher than 15cps/kBq.
The uMI 780 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.
Here's a breakdown of the acceptance criteria and study information for the uMI 780 PET/CT System, based on the provided text:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (Siemens Biograph mCT and mCT Flow PET/CT Scanners). Therefore, the "study" referred to here is primarily a set of non-clinical tests to verify performance and compliance with recognized standards, rather than a clinical trial directly demonstrating efficacy in a patient population.
1. Table of Acceptance Criteria (for key PET and CT specifications) and Reported Device Performance
The device performance is compared directly against the predicate device, which inherently sets the acceptance criteria based on established performance within the industry.
| Item | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (uMI 780) |
|---|---|---|
| PET Specification | ||
| Sensitivity | ≥ 9.4 cps/kBq | ≥ 15 cps/kBq |
| NECR Peak Value | ≥ 165 kcps @ 28 kBq/cc | ≥ 165 kcps @ 16 kBq/cc |
| Peak True Count Rate | ≥ 575 kcps @ 40 kBq/cc | ≥ 500 kcps @ 30 kBq/cc |
| PET Scatter Fraction | (No explicit value, implies comparable to predicate) | ≤ 40% |
| Count Rate Bias | (No explicit value, implies comparable to predicate) | ≤ ±5% |
| Axial FWHM@1cm Axial FWHM@10cm | (No explicit value, implies comparable to predicate) | ≤ 3.5mm ≤ 4.0mm |
| Transaxial FWHM@1cm Transaxial FWHM@10cm | (No explicit value, implies comparable to predicate) | ≤ 3.5mm ≤ 4.0mm |
| CT Specification | ||
| Scan Regime | Continuous Rotation | Continuous Rotation |
| Scan Modes | Topo, Axial Scan, Helical Scan | Topo, Axial Scan, Helical Scan |
| Z-plane coverage | 38.4mm | 40mm |
| Number of detector row | 64 | 80 |
| Minimum slice thickness | 0.6mm | 0.5mm |
| Rotation speed | Up to 0.3 sec for 360° rotation | Up to 0.3 sec for 360° rotation |
| Table Maximum table load | 227kg | 250kg |
| Safety and Compliance | ||
| Biocompatibility | Comply with ISO 10993-5, ISO 10993-10 | Comply with ISO 10993-5, ISO 10993-10 |
| Electrical Safety | Comply with ES 60601-1 | Comply with ES 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "No clinical study is included in this submission" (page 6). Therefore, there is no patient-based test set in the traditional sense for clinical performance. The testing was primarily non-clinical performance testing of the device's physical and technical specifications.
- Test Set: Not applicable in the context of human subjects or clinical data. The "test set" consisted of the device itself and phantoms used for performance measurements.
- Data Provenance: The tests conducted (e.g., NEMA NU 2:2012) are standardized laboratory or bench tests. The exact country of origin for the testing itself is not explicitly stated, but the manufacturer is based in Shanghai, China. The data is retrospective in the sense that it evaluates the device's technical specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this was primarily non-clinical performance testing of hardware and software specifications, there were no experts establishing ground truth for a clinical test set. The "ground truth" for these tests are the defined physical and electrical standards and the specifications measured against those standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
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
No MRMC study was done, as explicitly stated, "No clinical study is included in this submission." This device is a PET/CT scanner, not an AI-powered diagnostic algorithm in the typical sense that would necessitate a human-in-the-loop study for performance improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The document does not describe the evaluation of a standalone algorithm for diagnostic performance. The device itself is an imaging system. The performance testing was for the overall system's technical specifications (e.g., image quality, sensitivity, safety).
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" was established by recognized industry and international standards for medical imaging devices. These include:
- AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012 (Electrical safety)
- IEC 60601-1-3: Edition 2.1 (Radiation protection)
- IEC 60601-2-44: Edition 3.0 (X-ray equipment for CT)
- IEC 60601-1-2: Edition 3 (Electromagnetic compatibility)
- IEC 60825-1: Edition 2.0 (Laser safety, if applicable)
- NEMA 61223-3-5: First edition (Evaluation of the imaging performance of CT medical x-ray equipment)
- NEMA NU 2:2012 (Performance Measurements of Positron Emission Tomography Scanners)
- ISO 10993-10: Third Edition (Biological evaluation of medical devices - irritation and skin sensitization)
- ISO 10993-5: Third edition (Biological evaluation of medical devices - tests for in vitro cytotoxicity)
- NEMA XR 25: 2010 (Computed Tomography Dose Check)
- NEMA XR 28:2013 (Performance Measurements of Computed Tomography Systems with Dose Modulation)
- NEMA XR 29:2013 (Standard for the display of Imaging Information for Digital Mammography) (Likely an error, as this is a PET/CT system, not mammography, but listed in the document).
8. The Sample Size for the Training Set
Not applicable. This document does not describe a machine learning algorithm that underwent a training phase with a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.