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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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