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Spectrum Dynamics Medical's VERITON system is intended for use by trained healthcare professionals to aid in the detection, localization, diagnosis, staging and restaging of lesions, diseases, and organ function. For evaluating diseases and disorders such as cardiovascular disease, neurological disorders, and trauma. System outcomes can be used to plan, guide, and monitor 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.

SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT 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.

The VERITONCT 300/400 Series consist of back - to - back Single Photon Emission Computed Tomography (SPECT) and X-Ray Computed Tomography (CT) scanners. 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 CT's anatomical detail for precise reference of the location of the metabolic activity. CT subsystem 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 standalone diagnostic imaging devices.

All models employ a same software version 2.3.0

The proposed series consists of four variations:

Modifications in VERITON Family include:

Enhanced CZT module's introduction to support an extended energy range

The provided text describes the VERITON CT 300/400 Series Digital SPECT/CT System, a modification of previously cleared devices (VERITON CT 64 and VERITON CT 16). The submission focuses on demonstrating substantial equivalence to the predicate device VERITON CT 16 (K190457).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "All testing has met the acceptance criteria for the proposed device" for various performance metrics, but it does not explicitly list the specific acceptance criteria values for each test. It only states that the tests were conducted against the predicate device's performance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size (Clinical Evaluation): The document states "Sample clinical images." It does not specify the number of images or cases used in this clinical evaluation.
• Data Provenance (Clinical Evaluation): The document does not specify the country of origin of the clinical data nor whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: "a board-certified radiologist" (singular).
• Qualifications of Experts: "board-certified radiologist." The document does not provide information on the years of experience of this radiologist.

4. Adjudication Method:

• The document describes a single board-certified radiologist evaluating "sample clinical images" to confirm diagnostic quality. This indicates no formal adjudication method (like 2+1 or 3+1) was used, as it was a single reader assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The clinical evaluation involved a single radiologist confirming diagnostic quality, not comparing human readers with and without AI assistance to measure an effect size.

6. Standalone Performance Study:

• Yes, a standalone performance was done for several technical aspects. The document describes "non-clinical performance evaluations" using "a variety of test methods and phantoms" to characterize the performance of the device's functionality. This included areas like energy resolution, count rate linearity, uniformity, system resolution, and lesion detectability. These tests assess the algorithm's direct output on controlled inputs (phantoms) or simulated conditions, rather than human-in-the-loop performance.

7. Type of Ground Truth Used:

• For Non-Clinical Performance Tests (Standalone): The ground truth would typically be established by the characteristics of the phantoms used and the expected physical and mathematical properties of the SPECT/CT system being tested. These are objective measures based on known inputs.
• For Clinical Evaluation: The ground truth for this simple evaluation was the expert opinion/assessment of diagnostic quality by a board-certified radiologist. It doesn't mention more definitive ground truths like pathology or long-term clinical outcomes.

8. Sample Size for the Training Set:

• The document does not provide any information regarding the sample size of a training set. Given that the device is presented as a modification of existing systems, and the focus is on hardware/software modifications and demonstrating equivalence, it's possible that a new, extensive training set was not required if the underlying algorithms are largely unchanged. However, the document does not clarify this.

9. How the Ground Truth for the Training Set Was Established:

• Since there is no information on a training set, there is also no information on how its ground truth was established.

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