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NAEOTOM Alpha:
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.
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 (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.

Scan&GO:
This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are using special protocols.

The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA50 is a dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology.
The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the primary and secondary predicate devices, but support with improved technological characteristics as described in Section 10.
The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA50 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post processing applications.
The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient.

The Siemens NAEOTOM Alpha, Scan&GO Software (K220814) is a computed tomography x-ray system that received 510(k) clearance. The provided documentation primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics against ground truth.

However, based on the information provided, we can infer acceptance criteria for the non-clinical testing conducted to support the device modifications and their performance.

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

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes several non-clinical tests performed to demonstrate the functionality and performance of the modified features. The acceptance criteria for these tests are generally stated implicitly as the successful demonstration of the intended function and efficacy.

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

The document specifies "phantom tests" and "bench tests" for non-clinical testing. It does not provide specific sample sizes (e.g., number of phantoms, number of test runs) for these tests, nor does it explicitly state the data provenance in terms of country of origin or whether they were retrospective or prospective, beyond stating they were conducted "during product development." Given these are non-clinical hardware/software tests, the concept of "retrospective or prospective" data provenance (as typically applied to patient data) is not directly applicable.

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

The document does not mention the use of experts to establish a ground truth for the test set. The testing described is primarily non-clinical verification and validation of hardware and software modifications against engineering specifications and industry standards.

4. Adjudication method for the test set

As the testing is non-clinical and does not involve human interpretation against a ground truth, an adjudication method like "2+1" or "3+1" is not applicable and therefore not mentioned.

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

The document does not describe an MRMC comparative effectiveness study. The NAEOTOM Alpha and Scan&GO software, as described, do not appear to be an AI-assisted diagnostic tool that would typically undergo such a study. The software is for planning, control, image reconstruction, and post-processing, not for interpretation or AI-driven diagnostic assistance.

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

Yes, standalone (algorithm only) performance was assessed through the various non-clinical hardware and software verification and validation tests listed in the table above. These tests evaluate the device's inherent functionality, image quality, and compliance with technical specifications, without direct human interaction for interpretation or decision-making during the test itself.

7. The type of ground truth used

For the non-clinical tests described, the "ground truth" implicitly refers to:

• Engineering Specifications/Requirements: The design and performance targets set for the device's hardware and software features.
• Industry Standards: Compliance with recognized standards like NEMA, IEC, and ANSI AAMI for electrical safety, EMC, and image quality.
• Physical Properties: For tests like myNeedle Laser accuracy or iMAR efficacy, the ground truth would be the known physical characteristics or expected outcomes in phantom models.

There is no mention of "expert consensus, pathology, or outcomes data" as ground truth, which are typically found in clinical validation studies.

8. The sample size for the training set

The document does not provide information on a training set. This is consistent with the nature of the submission (510(k) for a CT system software update) which focuses on demonstrating substantial equivalence and safety/effectiveness through non-clinical testing, rather than developing or validating an AI algorithm that would typically require a training set.

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

Since no information on a training set is provided, how its ground truth was established is not applicable/not mentioned.

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NAEOTOM Alpha:
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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 (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Scan&GO:
This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.

Siemens intends to market a new CT scanner system NAEOTOM Alpha supporting software version, SOMARIS/10 syngo CT VA40 with mobile workflow options.
Dual Source CT Scanner System:

• NAEOTOM Alpha
• Scan&GO Mobile Medical Application (optional mobile workflow component) .
  The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA40 is a dual-source Computed Tomography (CT) x-ray system featuring two detectors based on new photon counting technology. The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the predicate devices, but support with improved technological characteristics.
  The NAEOTOM Alpha with Software SOMARIS/10 synqo CT VA40 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
  The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements.
  NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
  The software version for the NAEOTOM Alpha, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data manaqement, X-ray scan control, image reconstruction, and image archive/evaluation.
  The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.
  New software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is a modified software version based on syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the secondary predicate device and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the secondary predicate device Scan&GO cleared in (K200524).

The provided text describes a 510(k) premarket notification for the NAEOTOM Alpha CT scanner and Scan&GO application. It includes performance data from non-clinical testing.

Here's a breakdown of the requested information:

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

The document provides a general overview of performance testing and states that "all of the software specifications have met the acceptance criteria" and that verification and validation testing was "found acceptable to support the claim of substantial equivalence." However, it does not present a specific table with quantitative acceptance criteria and corresponding reported device performance metrics in a structured format for each feature. Instead, it describes the type of performance testing conducted for various features.

For example, for "Detector - QuantaMax," it mentions "in-depth evaluation of NAETOM Alpha Image Quality for general CT imaging, based on phantom evaluation of Typical Modes, compared to the predicate device SOMATOM Force. It also includes parameters for supporting the suitability of the subject device for low dose lung cancer screening." For "CARE keV," it states "The test procedure includes phantom measurements with clinically relevant phantom diameters and contrast materials to support the contrast, noise, and radiation dose related CARE keV information."

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

The document primarily discusses non-clinical testing which involves phantom studies. There is no mention of patient data (test set) being used for performance evaluation in the context of proving substantial equivalence, nor any information about data provenance (country of origin, retrospective/prospective). The testing described is performed on the device itself and phantoms.

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)

Since the testing described is primarily non-clinical (phantom studies) and doesn't explicitly involve human reader interpretation for a test set, there is no mention of experts establishing ground truth for a test set or their qualifications.

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

Given that no human reader-based test set evaluation is described for performance, there is no information on an adjudication method.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the substantial equivalence of the NAEOTOM Alpha CT scanner and its components to existing predicate devices, primarily through non-clinical performance testing and technical comparisons, not on measuring human reader performance with or without AI assistance.

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

Yes, the testing described appears to be a form of standalone algorithm-only (device-only) performance evaluation through phantom studies. The document details testing of features like "Quantum Iterative Reconstruction," "Detector - QuantaMax," "CARE keV," and "Quantum Pure Lumen" using phantom measurements and technical analyses to assess their performance characteristics, independent of human interpretation in a clinical setting.

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

For the non-clinical phantom studies, the ground truth would be the known physical properties and configurations of the phantoms (e.g., known material compositions, shapes, sizes, and concentrations of inserts). For example, for "Always Dual Energy," it mentions "phantoms with iodine inserts," where the known concentration and distribution of iodine would serve as ground truth for assessing accuracy.

8. The sample size for the training set

The document refers to the NAEOTOM Alpha as a new CT scanner system with modified software. It mentions that "software version SOMARIS/10 syngo CT VA40 is a further development of the SOMARIS/10 syngo CT VA30 software version," implying an evolution rather than a de novo AI algorithm that requires a separate training set. While the algorithms (like Quantum Iterative Reconstruction, CARE keV) have been optimized, the document does not specify a sample size for a training set in the context of distinct machine learning model training as one might expect for a typical AI/ML device. The focus is on the device's inherent imaging capabilities and reconstruction algorithms.

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

As there is no explicit mention of a training set or a distinct AI/ML model being trained with external data, there is no information on how ground truth for a training set was established. The development appears to be based on engineering principles, physics of CT imaging, and optimization of established reconstruction techniques for the new photon-counting detector technology.

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