(113 days)
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.
| Feature/Test | Acceptance Criteria (Inferred from description) | Reported Device Performance (Summary) |
|---|---|---|
| myNeedle Laser Functionality | Achieve defined accuracy level for laser visualization; demonstrate essential workflow steps. | The results of the accuracy test with a close to clinical workflow and test setup show that defined accuracy level can be achieved. The workflow evaluation showed a comparison to the essential workflow steps. |
| Flex 4D Spiral (Neuro & Body Perfusion/Dynamic Angio) | Proper function of dynamic collimation and dose modulation; acceptable image quality on NAEOTOM Alpha. | Demonstrated the proper function of dynamic collimation and dose modulation and assessed acceptable image quality of Flex 4D Spiral on NAEOTOM Alpha. |
| QuantumPlus UHR (Ultra-High Resolution) | Successful reconstruction of spectral images from raw UHR data. | Described the reconstruction of spectral images from raw data acquired in ultra-high resolution (UHR) modes. |
| PURE Calcium | Obtain modified image reconstruction that aims at removing iodine contribution from generated output images using spectrally acquired input data. | Described the feature "PURE Calcium," which uses spectrally acquired input image data to obtain a modified image reconstruction that aims at removing the iodine contribution. |
| Iterative Metal Artifact Reduction (iMAR) | Efficacy in reducing metal artifacts in phantom images. | Evaluation of phantom images demonstrated the efficacy of iMAR to reduce metal artifacts. |
| High Resolution Dual Source Cardiac Modes | Basic image quality and property of ECG gated ultra-high resolution dual-source cardiac acquisition mode. | The basic image quality and the property of the ECG gated ultra-high resolution dual source cardiac acquisition mode were described and found acceptable. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Compliance with standards IEC 60601-2-44 and IEC 60601-1-2. | Testing conducted in accordance with standards 60601-2-44, and 60601-1-2. |
| Software Verification and Validation | All software specifications meet acceptance criteria; risk control implemented for identified hazards. | Testing supports that all software specifications have met the acceptance criteria. Risk analysis completed and risk control implemented to mitigate identified hazards. |
| Wireless Coexistence Testing | Safe operation with other systems in a shared environment; successful communication despite potential interference; adherence to IEEE 802.11h for dynamic frequency selection and transmission power control. | Testing considered co-channel, adjacent channel, RF interference, and separation distance/location scenarios. Scan&GO supports dynamic frequency selection and transmission power control. Successfully ensured wireless communications were actively transmitting in situations where possible interference may exist. |
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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.