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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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VERITON™ NM is a Nuclear Medicine (NM) imaging system, intended to perform general nuclear medicine imaging procedures for the detection of radioisotope tracer uptake in a patient's body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

Scanning modes include whole body and tomographic (static, dynamic and multi-gated) mode, while acquisition types include single and multi-isotope single-photon imaging-enhancement features include gating by way of physiological signals and real-time automatic body contouring.

The VERITON™ NM system is a medical device intended for use by appropriately-trained healthcare professionals to aid in the detection, localization and diagnosis of diseases and organ function, for the evaluation of diseases, trauma, abnormalities and disorders. System output can be used by a physician for planning, guiding, and monitoring therapy.

SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: whole body imaging and tomographic imaging.

Software: System application software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, CT and other imaging modalities.

Spectrum Dynamics VERITON™ NM system is a single photon emission computing tomography system (SPECT) intended for detection of radioisotope tracer uptake in the body and to produce cross-sectional images through computer reconstruction of the data.

The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The system may utilize various modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion).

The VERITON™ NM system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. 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.

Here's a breakdown of the acceptance criteria and study information for the VERITON™ NM, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of specific numerical acceptance criteria and reported device performance for the VERITON™ NM. Instead, it states that:

• "All testing results have met the predetermined acceptance values."
• "Mathematical and physics analysis were performed to demonstrate that each performance metric/claim was successfully verified and substantiated."
• "The device has successfully completed all design control testing per our quality system. No new hazards were identified and no unexpected test results were obtained."

The document mentions that testing was conducted according to NEMA NU-1:2012. This standard specifies performance measurements for gamma cameras, and compliance implies meeting the criteria within that standard for the tested parameters.

Evaluated Areas (Implied Performance Metrics):

• Energy resolution
• Count rate linearity
• Uniformity
• System resolution
• Lesion detectability

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

The document explicitly states that the non-clinical performance evaluation testing "used a variety of test methods and phantoms appropriate for the performance metric/claim that was to be tested and evaluated."

• Sample Size for Test Set: Phantoms were used. The specific number or types of phantoms used for each test are not detailed in this summary.
• Data Provenance: This was an in-vitro (phantom-based) and non-clinical study. Therefore, there is no patient data or country of origin mentioned.

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

Not applicable, as the testing was performed using phantoms and engineering analysis, not human interpretation of patient data in an AI context. The "ground truth" for these tests would be the known physical properties and configurations of the phantoms.

4. Adjudication Method for the Test Set:

Not applicable, as the testing involved physical measurements and analysis against predetermined engineering and performance standards (NEMA NU-1:2012), not human adjudication of image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted. This document describes non-clinical performance testing of the imaging system itself, not a study of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

While the device includes "System application software is a display and analysis package intended to aid the clinician," the performance testing described here focuses on the imaging system's technical specifications and image quality using phantoms. It does not explicitly detail a standalone performance study of the algorithm's diagnostic capabilities on patient data. The summary is primarily about the hardware and core imaging performance.

7. Type of Ground Truth Used:

For the non-clinical performance testing, the ground truth was based on the known physical properties and configurations of the phantoms used, as well as established metrological standards (e.g., NEMA NU-1:2012).

8. Sample Size for the Training Set:

Not applicable. This document describes validation testing of the VERITON™ NM system, which is an imaging device (hardware and associated software), not an AI algorithm that requires a "training set" in the context of machine learning model development.

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

Not applicable, as there was no "training set" in the machine learning sense.

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The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting. localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treal ment planning and interventional radiology procedures.

SPECT: To detect or image the distribution ofradionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV

CT: The CT component is intended to produce 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.

SPECT+cT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Software: The :MIApplications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

The following satement applies only to the Semens Symbia Intevo 16 and Symbia Intevo Bold systems. This CT system can be used for low dose lung cancer screening in high risk populations ** ·As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (NEngl J Med 2011;365:395-409) and subsequent literature, for further information.

The Siemens Symbia systems consist of Sinqle Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT 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. 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 imaqing devices.

The Symbia SPECT/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Symbia SPECT/CT systems.

The provided text is a 510(k) Summary for Siemens Symbia T16, Symbia Intevo 16, and Symbia Intevo Bold SPECT/CT systems, seeking to add an indication for low-dose lung cancer screening. It describes performance testing conducted but does not explicitly define acceptance criteria or provide specific device performance results in a table format for the lung cancer screening indication.

Instead, it relies on the substantial equivalence principle, stating that the CT component within the SPECT/CT systems is identical in design, material, functionality, technology, and energy source to previously cleared standalone SOMATOM CT systems (K142955) that already have the low-dose lung cancer screening indication. Therefore, the performance testing for the standalone SOMATOM CT systems is considered applicable.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria and reported device performance for the lung cancer screening indication. It states:

• "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Symbia SPECT/CT systems is likewise suitable for lung cancer screening."

The document lists various parameters that were evaluated for the general CT use and confirmed to be the same between the integrated SPECT/CT CT subsystem and the standalone SOMATOM CT systems. These parameters are:

• CT number accuracy
• CT number uniformity
• Spatial resolution (MTF, maximum in-plane resolution)
• Slice thickness/sensitivity profile (minimum slice width)
• Noise properties (NPS and image Noise (standard deviation))
• Contrast to Noise Ratio
• Maximum scan speed
• Minimum reconstructed slice interval

However, specific acceptance criteria (e.g., "CT number accuracy within X%") or quantitative performance results for these parameters are not detailed in this document. It implies that the acceptance criteria and performance data from the K142955 submission for the predicate SOMATOM CT scanners are being leveraged.

2. Sample size used for the test set and the data provenance

The document does not explicitly state a sample size for a test set related to the low-dose lung cancer screening indication. It refers to:

• "clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011;365:395-409) and subsequent literature, for further information."

This implies that external clinical studies, such as the NLST, provide the evidentiary basis for the effectiveness of low-dose CT in lung cancer screening, rather than de novo testing on a new sample set for this specific submission. The data provenance would therefore be the NLST and other referenced clinical literature, which involved large cohorts. The document does not specify if the data was retrospective or prospective for any new testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned in the document for this specific submission's performance testing. The reliance is on existing clinical evidence and the performance characteristics of the predicate device.

4. Adjudication method for the test set

Not applicable/Not mentioned in the document for this specific submission's performance testing.

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

Not applicable. This device is an imaging system (CT scanner), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This submission is about the CT system itself. The performance testing referenced is for the CT component's imaging capabilities (e.g., resolution, noise, CT number accuracy), which are inherent to the device's function as an imaging modality. The "standalone" performance is assessed by comparing its technical parameters to those of the predicate standalone CT systems. The document states:

• "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems."

7. The type of ground truth used

For the general performance parameters listed (CT number accuracy, spatial resolution, etc.), the ground truth would be established through phantom studies or calibrated measurements performed during the CT testing, which is standard for imaging system validation.

For the clinical utility for lung cancer screening, the ground truth is established through the outcomes data (e.g., reduced mortality rates) from large-scale clinical trials like the National Lung Screening Trial (NLST), as referenced in the Indications for Use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm development and training scenario specified in the document.

9. How the ground truth for the training set was established

Not applicable.

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