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The iCT device with sliding gantry 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.

(*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).

iCT is a whole body x-ray computed tomography (CT) scanner. It combines a standard CT gantry with a ceiling mounted suspension and drive mechanism to move the gantry horizontally during image acquisition. The standard CT gantry features a continuously rotating tub-detector system and functions according to the fan beam principle. The ceiling mounted suspension and drive mechanism allows iCT to be moved along rails for storage or to share the iCT between multiple rooms. The ceiling mounted system also provides precise horizontal movement that is integrated with the CT scan control. During image acquisition, the iCT drive mechanism translates the CT gantry while the patient table remains stationary. Moving the gantry allows the patient to remain stationary instead of translating the patient relative to the gantry as is required with fixed gantry systems. iCT may be used with commercially available patient tables, including surgical tables, that meet the appropriate size and x-ray transmission characteristic requirements.

iCT leverages the previously cleared SOMATOM Definition, Model AS/AS+ (K081022) gantry, power supply and operator console components, including the syngo software platform and compatible syngo applications. iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.

Here's a breakdown of the acceptance criteria and study information for the iCT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document explicitly states that "sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies." This implies that clinical images were NOT used as a test set. The testing was done using "high precision phantoms." The specific number of phantoms or scans performed is not provided.
• Data Provenance: Not applicable, as clinical data was not used for the test set.

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

• Not applicable as the testing was conducted using "high precision phantoms" and laboratory studies, not clinical data and expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable, as the testing was conducted using "high precision phantoms" and laboratory studies, not human evaluation of clinical data.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states that "sample clinical images are unnecessary to support substantial equivalence in this case and instead testing relied on laboratory studies." This indicates the evaluation was technical and mechanical, not clinical or involving human readers.

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

• Yes, the primary evaluation was a standalone technical/mechanical evaluation of the iCT system's performance metrics (image quality, z-axis accuracy, gantry stability) against the specifications of the predicate device using phantoms. This is effectively a "standalone" assessment of the device's physical and image acquisition capabilities without human interpretation of clinical images.

7. The Type of Ground Truth Used

• The ground truth was established by the specifications and performance characteristics of the predicate device, specifically the SOMATOM Definition, Model AS/AS+ with the sliding gantry package. The iCT's performance was measured against these established technical benchmarks using "high precision phantoms."

8. The Sample Size for the Training Set

• Not applicable. The iCT is leveraging a previously cleared CT gantry, power supply and operator console components (SOMATOM Definition, Model AS/AS+), including its syngo software platform and compatible syngo applications. The iCT itself is primarily a modification concerning the physical mounting and movement of this existing CT technology (ceiling rails vs. floor rails). Therefore, it doesn't appear to involve its own separate "training set" in the context of an AI/algorithm. The core imaging algorithms are assumed to be from the predicate device.

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

• Not applicable, as a separate training set for the iCT's distinct features (ceiling mounted gantry movement) is not described, and the core imaging software/algorithms are inherited from the cleared predicate device. The information provided focuses on the physical and technical performance of the modified gantry system.

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The Siemens SOMATOM Definition AS Open systems are 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.

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

The Siemens SOMATOM Definition AS Open is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle.

This system is a modified version of the cleared Somatom Definition AS/AS+ The modification features a larger gantry bore from the original (K081022). Definition AS, In addition, the gantry tilt accuracy is improved and a new HD FoV, will help provide an optimized solution for radiation treatment planning.

The provided text describes a 510(k) summary for the Siemens SOMATOM Definition AS Open CT system. However, it does not include detailed information about specific acceptance criteria and a study proving device performance in the way requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Definition AS/AS+). Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device, and it typically doesn't require new clinical studies to demonstrate performance against specific quantitative criteria. Instead, it relies on demonstrating that any differences in technological characteristics do not raise new questions of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this type of submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the device itself in this submission. The acceptance criteria in a 510(k) summary for a substantially equivalent device often revolve around demonstrating that the new device meets the same safety and effectiveness standards as the predicate, often through engineering verification and validation that the modifications do not negatively impact performance.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, spatial resolution) are reported for the SOMATOM Definition AS Open. The submission focuses on describing the changes made from the predicate (larger gantry bore, improved gantry tilt accuracy, new HD FoV) and stating that the Data Measurement System is identical to the 32-row detector layout of the predicate.

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

• Not Applicable/Not Provided: This information is typically part of a clinical performance study. Since this is a substantial equivalence submission, such a study with a dedicated "test set" and associated sample size and data provenance is not described. The device's performance is inferred from the predicate device and engineering verification of the modifications.

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

• Not Applicable/Not Provided: As no clinical performance study with a distinct "test set" and ground truth establishment is described, this information is not relevant to this submission.

4. Adjudication method for the test set

• Not Applicable/Not Provided: See point 3.

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

• No: This is a CT scanner, not an AI-powered diagnostic device. A MRMC study, especially one involving AI assistance, would not be relevant in this context. The document does not describe any AI component.

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

• No: This device is a CT scanner. Its "performance" is about image acquisition, quality, and mechanical accuracy, not the output of a standalone algorithm for diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable/Not Provided: As no clinical performance study is described, no "ground truth" for diagnostic accuracy is established in this submission. The "ground truth" for a CT scanner typically relates to its physical and imaging performance (e.g., spatial resolution measured with phantoms, dose accuracy).

8. The sample size for the training set

• Not Applicable/Not Provided: There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of a CT scanner involve engineering design, component testing, and system integration, not training on a dataset in the AI sense.

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

• Not Applicable/Not Provided: See point 8.

Summary of what the submission does state regarding device validation:

• Substantial Equivalence: The primary method of "proving" the device meets acceptance criteria is by demonstrating its substantial equivalence to a legally marketed predicate device (Siemens SOMATOM Definition AS/AS+ K081022).
• Modifications: The device is a modified version of the predicate with:
  • A larger gantry bore (80 cm).
  • Improved gantry tilt accuracy.
  • A new HD FoV (Field of View).
  • It uses a modified tube collimator adapted to the 80 cm gantry bore.
  • The Data Measurement System (DMS) is identical to the 32-row detector layout of the SOMATOM Definition AS.
• Safety and Effectiveness: "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Somatom Definition AS Open is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
• Industry Standards: Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing to minimize electrical, mechanical, and radiation hazards.
• Intended Use: The intended use remains the same as the predicate: to produce cross-sectional images of the body. The modifications are specifically noted to "provided data that can be used for Radiation Therapy Planning (RTP) by RTP systems."

In essence, for a 510(k) submission showing substantial equivalence for a hardware modification of an existing device, the "study" proving it meets acceptance criteria is often a combination of engineering verification and validation testing to ensure the modifications do not introduce new risks and that the device performs as intended and on par with its predicate. No clinical study with PIs, ground truth, and statistical analysis is described in this document.

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The Siemens SOMATOM P47 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 P47 is able to produce additional image planes and analysis results by executing optional postprocessing features, which operate on DICOM images.

The images and results delivered by the system 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 xray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM P47 is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems 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 P47 system produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors.

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

The provided text describes a 510(k) submission for the Siemens SOMATOM P47, a computed tomography X-ray system. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML algorithm study would.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to predicate devices. This type of clearance relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed clinical study with acceptance criteria and performance metrics for a specific diagnostic task.

Therefore, many of the requested details, such as a table of acceptance criteria, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone performance, are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred:

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

This information is not available in the provided document. The 510(k) submission process for a CT scanner typically relies on demonstrating substantial equivalence to a predicate device through technical performance specifications, safety testing (electrical, mechanical, radiation), and software validation, rather than clinical performance metrics against specific diagnostic acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. As this is a CT scanner hardware and basic software system, clinical "test sets" for diagnostic performance, as understood for AI/ML algorithms, are not typically part of the 510(k) submission as presented here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. Ground truth establishment for diagnostic performance studies is not detailed as this document concerns a CT scanner's regulatory clearance, not a diagnostic AI's performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

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

This information is not available in the provided document. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which is not the focus of this CT scanner's 510(k) submission.

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

This information is not available in the provided document. The SOMATOM P47 is a CT imaging system, not a diagnostic algorithm meant to operate standalone from human interpretation. Its output (DICOM images) are "used by a trained physician as an aid in diagnosis."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document. For a CT scanner, "ground truth" would more likely refer to the accuracy of the physical measurements and image reconstruction parameters rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not available in the provided document. The SOMATOM P47 is a CT scanner, not a machine learning model that undergoes a "training" phase with a dataset in the conventional sense. Its software (SOMARIS/7) handles patient management, data management, X-ray scan control, image reconstruction, and archive/evaluation.

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

This information is not available in the provided document.

Summary based on the provided text:

The document describes the Siemens SOMATOM P47, a Computed Tomography X-ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. Its software (SOMARIS/7) manages patient data, X-ray scan control, image reconstruction, and archiving.

The device's regulatory clearance (K082220) was based on Substantial Equivalence to legally marketed predicate devices:

• Siemens SOMATOM Definition AS/AS+ (K081022 cleared 06/05/2008)
• Siemens SOMATOM Definition (K052216 cleared 09/08/2005)

The Indications for Use for the SOMATOM P47 are 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." It can also produce "additional image planes and analysis results by executing optional postprocessing features, which operate on DICOM images." The "images and results delivered by the system can be used by a trained physician as an aid in diagnosis."

Acceptance Criteria and Studies:
The document does not describe specific acceptance criteria and a study to prove the device meets these criteria in the context of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy against a clinical ground truth). Instead, the focus of this 510(k) summary is on demonstrating safety and effectiveness via substantial equivalence to previously cleared CT scanners. This typically involves:

• Technical Performance: Demonstrating that the device meets established performance standards for CT scanners (e.g., image quality metrics, dose reduction features, reconstruction speed, resolution). These would be derived from internal engineering specifications, but are not explicitly detailed as "acceptance criteria" with performance results in this public summary.
• Safety: Adherence to recognized and established industry practice and standards to minimize electrical, mechanical, and radiation hazards, confirmed through hazard analysis, verification, and validation testing.
• Software Validation: The software (SOMARIS/7) for patient/data management, scan control, image reconstruction, and archiving is validated to ensure it performs as intended and meets specifications.

The FDA's clearance states, "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates that the submitted information was sufficient to demonstrate equivalence, thereby implying adequate safety and effectiveness without requiring a new detailed clinical study to prove diagnostic performance against specific acceptance criteria.

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