(266 days)
The Imaging system of positron emission and X-ray computed tomography is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.
Imaging system of positron emission and X-ray computed tomography is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).
When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:
Cardiology:
- Cardiovascular disease
- Myocardial perfusion
- Myocardial viability
- Cardiac inflammation
- Coronary artery disease
Neurology:
- Epilepsy
- Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia. and frontotemporal dementia.
- Movement disorders, such as Parkinson's and Huntington's disease
- Tumors
- Inflammation
- Cerebrovascular disease such as acute stroke, chronic and acute ischemia
- Traumatic Brain Injury (TBI)
Oncology/Cancer:
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
- Breast Cancer
- Prostate Cancer
- Hodgkin disease
- Non-Hodakin Ivmphoma
- Colorectal Cancer
- Melanoma
Imaging system of positron emission and X-ray computed tomography is also intended for standalone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.
The Imaging system of positron emission and X-ray computed tomography (model: DigitMI 930) is a PET/CT diagnostic imaging system combining a Positron Emission Tomography (PET) System and a Computed Tomography (CT) System.
The Imaging system of positron emission and X-ray computed tomography (model: DigitMI 930) consists of a scanning system, power distribution unit, table system, data processing system, and console system. The PET part consists of a 72 ring LYSO detector, while the CT part has 64 physical rows of detectors.
The provided FDA 510(k) summary for the Imaging system of positron emission and X-ray computed tomography (DigitMI 930) does not contain information about specific acceptance criteria related to a clinical study or device performance against clinical metrics. Instead, it focuses on non-clinical performance specifications and regulatory standards for showing substantial equivalence to a predicate device.
Here's an analysis of the information provided, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document provides a "Performance Comparison" table that lists various physical and imaging specifications for the proposed device and compares them to the predicate device (Discovery MI, K161574). These are not clinical acceptance criteria in the sense of accuracy, sensitivity, or specificity for a diagnostic task, but rather technical performance metrics of the PET/CT system itself. The "Remark" column for these items is consistently "Analyse 1," indicating that any differences were further evaluated.
| ITEM | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|---|
| PET Specification: | |||
| Sensitivity | ≥ 12.6cps/kBq | > 16.3cps/kBq | Analyse 1: Proposed device has higher sensitivity, indicating better performance. |
| NECR Peak Value | ≥ 162 kcps@18kBq/cc | > 125kcps@5.3kBq/cc; > 325kcps@33.9kBq/cc | Analyse 1: Different operating points, but the proposed device shows higher peak count rates at certain activity concentrations, suggesting improved performance in handling higher count rates. After comparing more carefully, the operating points are different. No direct comparison is possible. However, the proposed device shows high NECR values. |
| Peak True Count Rate | ≥ 847.1 kcps@34.2kBq/cc | > 1284kcps@49.2kBq/cc | Analyse 1: Proposed device shows a significantly higher peak true count rate at a higher activity concentration, indicating advanced performance. |
| PET Scatter Fraction | ≤ 45% | ≤ 39% | Analyse 1: Proposed device has a lower scatter fraction, which is desirable for image quality. |
| Count Rate Bias | ≤ ±5.5% | ≤ ±5% | Analyse 1: Proposed device has a slightly tighter tolerance for count rate bias, indicating more accurate quantification. |
| Axial FWHM@1cm |
§ 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.