(56 days)
The uMI 550 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 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, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
The uMI 550 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 395ps. It has a 240mm-long axial field of view (FOV) and a system sensitivity ~11cps/kBq.
The uMI 550 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.
The provided text is a 510(k) summary for a medical device (uMI 550 PET/CT System) and primarily focuses on demonstrating substantial equivalence to a predicate device (uMI 780). It outlines technical specifications, intended use, and general safety/performance testing.
However, the document specifically states: "No Clinical Study is included in this submission." This means that a clinical study proving the device meets specific performance acceptance criteria based on human-in-the-loop or standalone AI performance, as outlined in the questions, was not conducted or presented in this submission.
Therefore, many of the requested details, such as acceptance criteria met by a specific study, sample sizes for test sets, expert involvement for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment for clinical data, cannot be extracted from this document, as a clinical study was not performed for this submission.
The document focuses on non-clinical testing, electrical safety, electromagnetic compatibility, and conformance to various industry standards for imaging performance, software, biocompatibility, and risk management to demonstrate substantial equivalence to a predicate device.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in the format of pass/fail clinical thresholds or a table demonstrating performance against such criteria. It lists technical specifications for the PET and CT components and states conformance to various electrical safety, EMC, and imaging performance standards. It mentions "The testing results show that all the software specifications have met the acceptance criteria" in relation to software verification and validation, but these specific criteria or results are not detailed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data from a clinical study is provided.
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. No clinical test set and thus no experts establishing ground truth for such a set are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is mentioned.
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. The document explicitly states: "No Clinical Study is included in this submission." Therefore, no MRMC study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The document explicitly states: "No Clinical Study is included in this submission." Therefore, no standalone performance evaluation of an algorithm (likely AI, though the document doesn't detail AI components beyond general "software") was conducted or reported here. The device itself is an imaging system, not an AI algorithm for image interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As no clinical study was performed, there's no mention of ground truth for patient data. The ground truth for non-clinical performance (e.g., image quality, system calibration) would be based on phantoms and physical measurements, and conformance to industry standards like NEMA NU 2-2012.
8. The sample size for the training set
Not applicable. No AI algorithm requiring a training set is discussed or evaluated in terms of its performance in a clinical setting.
9. How the ground truth for the training set was established
Not applicable. As no AI algorithm and training set are discussed, how ground truth for such a set was established is not relevant to this submission.
In summary, this 510(k) submission for the uMI 550 PET/CT System relies on demonstrating substantial equivalence to a predicate device (uMI 780) through non-clinical performance data (phantom studies, electrical safety, EMC, software validation, etc.) and conformance to relevant industry standards, rather than through a clinical study that evaluates human reader performance or AI algorithm performance.
§ 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.