(134 days)
The syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media.
It generates the following result volumes:
- Cerebral blood flow (CBF)
- Cerebral blood volume (CBV)
- Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD))
- Mean transit time (MTT)
- Transit time to the center of the IRF (TMax)
- Flow extraction product (permeability)
- Temporal MIP
- Temporal Average
- Baseline Volume
- Modified dynamic input data
The software also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and the parameter mismatch in brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- Lower signal intensity for CBF and CBV
- Higher signal intensity for TTP, TTD, MTT, and TMax
A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
The syngo. CT Neuro Perfusion software allows the quantitative evaluation of dynamic CT data of the brain acquired during the injection of a compact bolus of iodinated contrast material. It mainly aids in the early differential diagnosis of acute ischemic stroke. Blood-brain-barrier (BBB) imaging also supports the diagnostic assessment of brain tumors.
By providing images of e.g. cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and Mean Transit Time (MTT) from one set of dynamic CT images or volumes, syngo.CT Neuro Perfusion allows a quick and reliable assessment of the type and extent of cerebral perfusion disturbances. The underlying approaches have been validated in extensive clinical studies and have been in routine clinical use for more than 10 vears.
The current syngo.CT Neuro Perfusion implementation allows simultaneous multi-slice processing and supports the workflow requirements in a stroke workflow. The availability of flow extraction product imaging extends the option to the diagnosis of brain tumors.
The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria. It mainly focuses on the device's substantial equivalence to a predicate device and its indications for use.
However, based on the information available, I can infer some aspects related to non-clinical testing and general acceptance.
Here’s an attempt to structure the answer based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Standards (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|
| Conformity to IEC 60601-1-6 (Usability) | Non clinical tests were conducted during product development to fulfill these requirements. |
| Conformity to IEC 62304 (Software Lifecycle) | Non clinical tests were conducted during product development to fulfill these requirements. The testing results support that all software specifications have met the acceptance criteria. |
| Conformity to ISO 14971 (Risk Management) | Risk analysis was completed and risk control implemented to mitigate identified hazards. |
| Conformity to DICOM Standard (2008) | DICOM conformity is fully covered by syngo.via implementations. |
| Mitigation of identified hazards | Risk analysis completed and risk control implemented. |
| Software specifications performance | All software specifications have met the acceptance criteria, as supported by testing results. |
| Verification and Validation for Substantial Equivalence | Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. |
| Safe and effective use based on labeling | Device labeling contains instructions for use and necessary cautions/warnings for safe and effective use. |
| No new potential safety risk compared to predicate | Siemens' opinion is that the device does not introduce any new potential safety risk and performs as well as the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective study design). The discussion of testing is general and relates to non-clinical software verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The filing describes non-clinical testing for software verification and validation rather than a clinical performance study with expert ground truth.
4. Adjudication method for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document describes a software package for post-processing CT data and does not detail studies on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document discusses "non clinical tests" for software verification and validation, and states that "all the software specifications have met the acceptance criteria." This implies a form of standalone performance assessment against predefined specifications, but the specifics of how "standalone" this was (e.g., if it involved simulated data or real patient data processed without human intervention for evaluation) are not detailed. It's not a clinical standalone study in the sense of diagnostic accuracy against a ground truth.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to "non clinical tests" and "software specifications" rather than clinical ground truth like pathology or expert consensus from a clinical study. The "ground truth" for these non-clinical tests would likely be the expected output or behavior according to the software's functional requirements and design specifications.
8. The sample size for the training set
The document does not specify a sample size for a training set. The software likely relies on pre-established algorithms for generating perfusion maps, which would have been developed and "trained" (or validated) on various datasets over many years, as indicated by: "The underlying approaches have been validated in extensive clinical studies and have been in routine clinical use for more than 10 years." However, specifics about this device's training set are absent.
9. How the ground truth for the training set was established
The document mentions that "The underlying approaches have been validated in extensive clinical studies and have been in routine clinical use for more than 10 years." This suggests that the ground truth for the "training" (or more accurately, the development and historical validation of the underlying algorithms) would have been established through clinical studies, but the specific methods (e.g., expert consensus, correlation with other imaging modalities, or patient outcomes) are not detailed in this 510(k) summary for this particular device.
§ 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.