(56 days)
The uMI Panorama 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 metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion 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, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.
This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society * * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The proposed device uMI Panorama GS combines a 148 cm axial field of view (FOV) PET and multi-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET gantry, CT gantry, patient table, power supply cabinet, console and reconstruction system, chiller, vital signal module.
The uMI Panorama GS is an extended Field of View scanner based on uMI Panorama 35. The PET system uses the detector elements that is same with the predicate device. The gantry has been designed to extend the PET detector to 504 rings, which is different from 120 rings of the uMI Panorama 35.
The CT system is UIH's commercially available uCT ATLAS Astound (K223028) with 40 mm detector, which can also be used for standalone, diagnostic CT imaging.
The patient table has 250 kg maximum load capacity which allows flexible positioning and access for all patients.
The PSC and chiller provide higher capacity to meet the extended PET system power supply and cooling requirement, compared to uMI Panorama 35.
The control and reconstruction system contains image acquisition and reconstruction, image display and post processing analysis, data and patient management, CT dose display, networking, filming, etc.
Vital signal module is identical to those of the predicate device uMI Panorama 35.
The provided text describes the 510(k) summary for the uMI Panorama GS, a PET/CT system, but it primarily focuses on non-clinical performance data and its substantial equivalence to a predicate device (uMI Panorama 35). It does not include detailed acceptance criteria or a study proving the device meets those criteria, particularly in terms of clinical performance or a multi-reader multi-case (MRMC) study.
However, I can extract information related to the device's performance testing and the type of information that would be relevant to acceptance criteria.
Based on the provided text, the following information can be extracted:
1. A table of acceptance criteria and the reported device performance
The document mentions "Image performance test was conducted for uMI Panorama GS to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device." However, specific quantitative acceptance criteria (e.g., specific image quality metrics, sensitivity, specificity, resolution) and their corresponding reported device performance values are not detailed in this summary. The summary focuses on conformance to standards rather than specific performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The summary only refers to "Image performance test" without specifying the test set characteristics or data provenance.
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)
This information is not provided in the document. As there is no mention of a clinical study or human reader evaluation, no experts for ground truth establishment are discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in this summary. The document focuses on the technical specifications and non-clinical performance of the PET/CT system itself, not on an AI component or its impact on human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm (without human-in-the-loop) was not mentioned in this summary. The device described is a complete PET/CT imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For the non-clinical image performance tests, the "ground truth" would likely be based on physical phantom measurements and known parameters, but this is not explicitly stated.
8. The sample size for the training set
This information is not provided in the document. Since this is a hardware device (PET/CT system) rather than an AI/ML algorithm-driven software device in the context of this summary, a "training set" in the typical AI sense is not applicable or discussed.
9. How the ground truth for the training set was established
This information is not provided in the document, for the same reasons as #8.
Summary of what is available regarding testing and performance:
The document states that non-clinical testing was conducted for the uMI Panorama GS to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device (uMI Panorama 35).
The company claims conformance to various standards and guidance documents related to:
- Electrical Safety and Electromagnetic Compatibility (EMC)
- Medical electrical equipment standards (e.g., IEC 60601 series)
- Safety of laser products (IEC 60825-1)
- Usability (IEC 60601-1-6)
- Medical device software lifecycle processes (IEC 62304)
- Performance Measurements of Positron Emission Tomographs (NEMA NU 2-2018)
- Digital Imaging and Communications in Medicine (DICOM) (NEMA PS 3.1-3.20)
- Guidance for software in medical devices and cybersecurity
- Biocompatibility (ISO 10993 series)
- Risk management (ISO 14971)
- Quality System Regulation (21 CFR Part 820)
- Radiological Health regulations (21 CFR, Subchapter J)
The conclusion is that "the uMI Panorama was found to have a safety and effectiveness profile that is similar to the predicate device." and "The proposed device is determined to be Substantially Equivalent (SE) to the predicate device." This implies that meeting these standards and demonstrating similar performance to the predicate device are the primary "acceptance criteria" for the 510(k) submission, specifically relying on non-clinical performance data.
In essence, the document presents a regulatory compliance summary rather than a detailed clinical performance study with specific acceptance criteria and outcome data as might be found for an AI diagnostic 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.