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The Siemens SOMATOM Perspective system 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.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.

For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Similar to the predicate device (Siemens SOMATOM Emotion 16 premarket notification K050297, clearance date 03/01/2005), Siemens SOMATOM Perspective is a Computed Tomography X- ray System, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM Perspective system produces CT images in DICOM format, which can be used by post processing applications commercially distributed by Siemens and other vendors.

SOMATOM Perspective operates with software version SOMARIS/5 which is a Windows XP®1 based program used for patient management, data management. X-ray scan control, image reconstruction, and image archive/evaluation.

The key software new features for SOMATOM Perspective are iTRIM (Iterative Temporal Resolution Improvement Method) to improve the temporal resolution to a value of about 80% of that of conventionally reconstructed images, and ECO Mode (eMode) to increase the tube life by reducing the tube power.

The computer system delivered with the CT scanner is able to run such post processing applications optionally.

The provided document is a 510(k) summary for the Siemens SOMATOM Perspective CT system. It does not contain acceptance criteria for device performance or the details of a study demonstrating that the device meets such criteria in terms of clinical output or diagnostic accuracy.

The summary focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Emotion 16) based on technical characteristics and intended use. The "Nonclinical Testing" section mentions verification and validation testing, as well as phantom testing, but it does not provide specific acceptance criteria or detailed results from these tests in relation to clinical performance or diagnostic outcomes.

Therefore, for almost all of the requested information, the answer will be "Not provided in the document."

Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance Study for SOMATOM Perspective

The 510(k) summary provided does not detail specific acceptance criteria related to clinical performance (e.g., diagnostic accuracy, sensitivity, specificity) for the SOMATOM Perspective, nor does it present a study demonstrating the device meets such criteria for clinical or diagnostic endpoints.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and functionality, particularly for the new features like iTRIM and eMode. It mentions that "The testing results supports that all the software specifications have met the acceptance criteria," but these "software specifications" are not defined in terms of clinical outcomes or performance metrics in a way that would answer the specific questions below.

The "Nonclinical Testing" section refers to phantom testing and verification/validation, which are typical for medical device submissions, but no specific performance statistics are presented.

Therefore, the following information is largely not available from this document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document states that "all the software specifications have met the acceptance criteria" but does not define these criteria or report specific performance metrics (like diagnostic accuracy, sensitivity, etc.) relevant to a clinical study.

2. Sample Size Used for the Test Set and Data Provenance: Not provided. The document mentions "nonclinical tests" including "phantom testing" but does not describe a test set based on patient data, its size, or provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not provided. Since a clinical test set with ground truth is not described, this information is not applicable here.

4. Adjudication Method for the Test Set: Not provided. As no clinical test set for diagnostic performance is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC comparative effectiveness study is mentioned in the provided text. The document refers to the iTRIM algorithm improving temporal resolution, stating that "Actual results obtained with iTRIM can vary depending on the particular clinical situation," but it doesn't quantify this improvement in terms of human reader performance or diagnostic effectiveness compared to a standard method.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No standalone diagnostic performance study (e.g., sensitivity, specificity, AUC) for the algorithm itself is presented. The document states that the images and results "can be used by a trained physician as an aid in diagnosis," implying human-in-the-loop operation, but no performance metrics for such use are provided.

7. Type of Ground Truth Used: Not provided. Since no clinical performance study is detailed, the type of ground truth is not mentioned.

8. Sample Size for the Training Set: Not provided. The document does not describe the development or training of an AI model with a training set.

9. How the Ground Truth for the Training Set was Established: Not provided. As no training set is described, this information is not applicable.

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The Siemens Biograph True Point systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

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 PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging 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 treatment planning and interventional radiology procedures.

The Biograph True Point systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph True Point systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph True Point software is a command based program used for patient management. data manaqement, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The Biograph True Point systems which are the subject of this application are substantially equivalent to the commercially available Biograph mCT and Biograph True Point 64/40 systems and the Siemens Somatom CTs. Modifications include the integration of CT, PET and Patient Handling Systems to create an additional model to the Biograph True Point family of systems, and update of the system software.

The provided text details a 510(k) Premarket Notification for the Siemens Biograph True Point System, a combined CT and PET scanner. However, it does not contain specific acceptance criteria, a study design, or performance metrics for an algorithm or AI. Instead, it describes the device itself, its intended use, claims of substantial equivalence to predicate devices, and regulatory compliance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, ground truth for test and training sets) cannot be extracted from this document as the information is not present.

Here's a summary of what can be extracted:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or reported device performance in the manner typically associated with an AI or algorithm study (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices and compliance with relevant industry standards and regulations.

Table of Acceptance Criteria and Reported Device Performance (as inferable from the document):

Missing Information Not Present in the Document:

1. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/algorithm study. The 510(k) focuses on hardware and software system equivalence, not a performance trial using a clinical dataset.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 a imaging system, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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