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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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The GE StarGuide system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging of tumors, planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures. The GE StarGuide system, combining a CZTbased, high energy and spatial resolution, Nuclear Medicine (NM) system and a Computed Tomography (CT) system, is intended to produce:

· NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using tomographic scanning of single or multi-isotopes with either single or multi energy peaks. The tomographic scanning is supported by various acquisition types and by imaging features designed to enhance image quality.

· CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications.

· NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based corrections of SPECT images as well as functional and anatomical mapping imaging (localization, registration and fusion).

The GE StarGuide system includes digital processing of data and images, signal analysis and display equipment, patient and equipment supports, components and accessories. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

FAME: Functional-Anatomical Mutual Enhancement (FAME) technology is an image processing method intended for Computed Tomography (CT) based corrections of Nuclear Medicine (NM) bone scintigraphy images. FAME adjusts the radioisotope tracer distribution to correlate with the skeletal anatomical structures in the CT image. FAME may be used for patients of all ages.

StarGuide is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available GE Optima CT540 CT system. It is intended for general purpose Nuclear Medicine (NM) imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. The StarGuide system does not introduce any new Intended Use.

Each of StarGuide's twelve CZT detectors can independently rotate about their long axis and "sweep" the field of view (FOV). The detectors can also move rotationally around the gantry and radially in and out, similar to that of the reference device, Spectrum Dynamics' Veriton CT. The detectors on StarGuide's NM system are built up from the identical same CZT modules that are used in the current production version of the predicate device.

StarGuide's table is the same as the one used on the NM/CT 860 reference systems with only slight modifications. StarGuide's "SmartConsole" is the same as that on the NM/CT 850 and NM/CT 860 with modifications made primarily in support of StarGuide image processing. StarGuide's image processing (i.e. reconstruction and post reconstruction processing) uses known algorithms and methods that have been cleared for emission computed tomography (i.e. SPECT, PET). However, StarGuide introduces a new post reconstruction image processing algorithm, FAME, for CT-based correction of NM bone scintigraphy images for better correlation with the skeletal anatomical structures in the CT image.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the StarGuide system, particularly focusing on the FAME technology.

1. Table of Acceptance Criteria and Reported Device Performance (FAME Technology)

The document primarily focuses on the FAME technology as a new image processing algorithm introduced with the StarGuide system. The acceptance criteria for FAME are implicitly tied to its intended purpose as an "image processing method intended for Computed Tomography (CT) based corrections of Nuclear Medicine (NM) bone scintigraphy images. FAME adjusts the radioisotope tracer distribution to correlate with the skeletal anatomical structures in the CT image."

While a formal table of quantitative acceptance criteria for FAME is not explicitly provided with numerical thresholds, the performance is evaluated through a clinical reader study. The key performance indicator reported is that all five experienced Nuclear Medicine (NM) physicians attested that their assessments (using 5-point Likert scales for overall image quality and image resolution) demonstrated acceptable diagnostic results. This qualitative assessment serves as the reported device performance against the implicit acceptance criterion of providing diagnostically acceptable images after FAME processing.

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

• Sample Size for Test Set: 42 SPECT CT exams.
• Data Provenance: The exams were acquired using the StarGuide system at two clinical sites. The text does not explicitly state the country of origin, but it can be inferred that these are clinical settings where SPECT CT exams are routinely performed. The study is prospective in the sense that these specific exams were acquired on the StarGuide system for the purpose of this evaluation.

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

• Number of Experts: Five experienced NM physicians.
• Qualifications of Experts: Described as "experienced NM physicians." No specific years of experience are provided, but the term "experienced" implies sufficient expertise to evaluate diagnostic images.

4. Adjudication Method for the Test Set

The document mentions that the five experienced NM physicians "scored the images using 5 point Likert scales for both overall image quality and image resolution." It does not explicitly detail an adjudication method like 2+1 or 3+1 for discrepancies. Instead, it states that "All of the physicians attested that their assessments demonstrated acceptable diagnostic results," suggesting a consensus on acceptability or individual assessment without requiring a formal adjudication process beyond individual scoring.

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

• The document describes a clinical reader study, which is a type of MRMC study.
• Effect Size of AI vs. Without AI Assistance: The study as described focuses on the diagnostic acceptability of images after FAME processing. It does not provide an effect size comparing human readers with AI assistance versus human readers without AI assistance, or the specific improvement in reader performance. The evaluation is on the acceptability of the FAME-processed images themselves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The text states, "StarGuide introduces a new post reconstruction image processing algorithm, FAME, for CT-based correction of NM bone scintigraphy images for better correlation with the skeletal anatomical structures in the CT image." The reader study directly evaluates the output of this algorithm as interpreted by human readers. While the algorithm operates "standalone" in its processing, the ultimate performance is assessed through human interpretation, making it difficult to completely separate it. However, the study's focus is on the output of the algorithm and its diagnostic acceptability, which could be considered an evaluation of the algorithm's effect. There isn't a separate, entirely automated, quantitative standalone performance metric reported.

7. Type of Ground Truth Used

The ground truth for the reader study appears to be expert consensus on diagnostic acceptability. The physicians attested to "acceptable diagnostic results" for the images processed with FAME. This is an assessment of image quality and resolution in a diagnostic context, rather than a comparison to pathology or long-term outcomes data.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set used for the FAME algorithm. It mentions that FAME is a "new post reconstruction image processing algorithm," but no details on its development or training data are given in this summary.

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

As no information about a training set is provided, the method for establishing its ground truth is also not mentioned.

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