(59 days)
The Spectrum Dynamics Medical's VERITON™ CT is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and trauma. The system output can be used for planning, guiding, and monitoring therapy.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; whole body and tomographic imaging.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles. The CT part is indicated for pediatric and adult patients.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
VERITON™ CT consists of Single Photon Emission Computed Tomography (SPECT) scanners and integrated X-Ray Computed Tomography (CT). The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates the CT's anatomical details for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand- alone diagnostic imaging devices.
The provided text describes the VERITON™ CT whole body SPECT/CT system, a medical imaging device. However, it does not contain detailed information about specific acceptance criteria for a study, nor does it present a detailed study proving the device meets those criteria in the format requested.
The document discusses "Performance testing" and "Summary of Non-Clinical Testing" which state that "All testing has met the acceptance criteria for the proposed device." It also mentions a "Summary of Clinical Testing" where a radiologist evaluated sample images for diagnostic quality.
Based on the information provided, I can only generate a partial answer, focusing on the available details and explicitly stating when information is missing.
Here's the breakdown of what can be extracted:
- A table of acceptance criteria and the reported device performance
- The document states that "All testing has met the acceptance criteria for the proposed device" for areas like energy resolution, count rate linearity, uniformity, system resolution, and lesion detectability. However, the specific numerical or descriptive acceptance criteria and the reported device performance values are not provided.
| Acceptance Criteria (Specifics Not Provided) | Reported Device Performance |
|---|---|
| Non-Clinical Performance: | |
| Energy resolution | Met acceptance criteria |
| Count rate linearity | Met acceptance criteria |
| Uniformity | Met acceptance criteria |
| System resolution | Met acceptance criteria |
| Lesion detectability | Met acceptance criteria |
| Clinical Performance: | |
| Diagnostic quality of SPECT images | Confirmed by radiologist |
| Diagnostic quality of CT images | Confirmed by radiologist |
| Diagnostic quality of SPECT/CT images | Confirmed by radiologist |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical testing. For clinical testing, it states "Sample clinical images" which implies an unspecified number, likely small, and not a statistically defined test set.
- Data Provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a board-certified radiologist" (one expert).
- Qualifications: "board-certified radiologist." Specific experience (e.g., "10 years of experience") is not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: "None" or not applicable, as only one radiologist was used for evaluation.
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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
- MRMC Study: No, there is no indication of an MRMC comparative effectiveness study involving human readers with and without AI assistance. This device is an imaging system, not explicitly a standalone AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The document describes the device (VERITON™ CT system) performance and capabilities. It doesn't detail an "algorithm only" performance separate from the integrated system. The clinical "evaluation" involved a human radiologist reviewing images produced by the system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For clinical evaluation, the ground truth was established by a "board-certified radiologist" confirming "diagnostic quality." This points to expert opinion/evaluation rather than a definitive "ground truth" like pathology for specific disease detection accuracy. For non-clinical testing, phantoms were used, but the specific "ground truth" for e.g. "lesion detectability" in phantoms is inherent to the phantom design.
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The sample size for the training set
- Training Set Sample Size: Not applicable/not specified. The document describes a medical imaging device, not a machine learning model that would typically have a separate training set.
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How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there's no mention of a traditional "training set" for a machine learning model.
§ 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.