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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:

1. 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.

2. 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.

3. 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.

4. 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.

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

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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The Analogic CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 CT Scanner systems are indicated for pediatric and adult patients.

The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration).

The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.

The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).

Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.

The provided text describes specific performance data for the Analogic CTXX85 CT Scanner, particularly focusing on the CT1685 model and its iterative reconstruction algorithm (LISA). However, the document does not present a formal table of acceptance criteria with corresponding reported device performance, nor does it detail a clinical study with specific metrics like sensitivity, specificity, or reader performance improvement (MRMC).

Based on the information provided, here's a breakdown of the requested elements:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of acceptance criteria with precise numerical targets. Instead, it indicates that the device's performance was evaluated against a set of standards and for image quality. The general acceptance criterion seems to be that the device "performs as intended" and its image quality is "diagnostic."

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

• Sample Size: The document mentions "Sample clinical images of the brain, chest, abdomen and extremity" but does not specify a numerical sample size for this evaluation.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: One "board-certified radiologist" was used.
• Qualifications: "board-certified radiologist." No information on years of experience is provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that a single board-certified radiologist evaluated the images.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The evaluation involved a single radiologist confirming diagnostic quality of images. Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document.

6. Standalone (Algorithm Only) Performance

The document states, "Image Quality performance testing for the CT1685 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body." This indicates that standalone performance testing on phantoms was done to evaluate the image quality produced by the device, including its iterative reconstruction algorithm (LISA).

7. Type of Ground Truth Used

• For the phantom studies: The ground truth was based on physical phantom characteristics and established imaging metrics (e.g., MTF, low contrast detectability, noise, CT number accuracy).
• For the clinical image evaluation: The ground truth was established by expert consensus (albeit by a single expert), specifically the assessment of "diagnostic quality" by a board-certified radiologist.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This submission appears to be related to the substantial equivalence of a new model (CT1685) within an existing product line (CTXX85) and the performance of an advanced algorithm (LISA), but it doesn't detail the development or training of such an algorithm. The current document focuses on verification and validation testing of the device itself.

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

As no training set is mentioned, there is no information on how its ground truth was established.

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