(88 days)
• This application is image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
• This application software receives medical image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities or image archives such as PACS through network or media, and provides for the viewing, quantification, manipulation, communication, printing and management of medical images.
•This application software is intended only for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
• Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which this application is being offered.
Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, RT Image.
The Ziostation2 is an image processing application software for viewing, quantifying, manipulating, communicating, printing, and managing medical images from various modalities. The 510(k) summary (K181892) indicates that several new functionalities and enhancements were added to the Ziostation2, building upon the features of the previously cleared Ziostation2 (K151212) and other predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the Ziostation2 software itself. Instead, the document focuses on demonstrating substantial equivalence to predicate devices for its new functionalities and enhancements. The acceptance criteria appear to be based on the functional similarity and safety of the new features compared to already legally marketed devices.
However, based on the text, we can infer that the general "acceptance criterion" is that the new functionalities (LAA analysis, Lung Lobes, Virtual Bronchoscopy, CT Lung Resection Planning, MR Myocardial T1 Mapping) perform similarly to their counterparts in the predicate devices and do not introduce new safety or effectiveness concerns.
| Feature/Functionality | Acceptance Criterion (Inferred) | Reported Device Performance (as per 510(k) Summary) |
|---|---|---|
| Overall Ziostation2 (K151212 aspects) | No significant functional differences from the already cleared Ziostation2 (K151212). Improvements in workflow and usability are acceptable as long as core functionality is maintained. | "With respect to the already-cleared intended use of Ziostation2, no significant functional differences exist between Ziostation2 and SE K151212. Certain improvements in workflow and usability have been implemented." |
| LAA analysis (Goddard) | "Adding Goddard score classification" should function similarly to the legally marketed feature in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K130542) and other LAA analysis features cleared in CT PULMONARY ANALYSIS (K130552). | "LAA analysis (Goddard) is adding Goddard score classification to Ziostation2. The feature of Goddard score classification is legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K130542. Other features are previously cleared in CT PULMONARY ANALYSIS K130552 including LAA analysis." |
| Lung Lobes | "Adding lung lobes extraction" should function similarly to the legally marketed feature in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K130542) and other features cleared in CT PULMONARY ANALYSIS (K130552). | "Lung Lobes is adding lung lobes extraction to Ziostation2. The feature of lung lobes extraction is legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K130542. Other features are previously cleared in CT PULMONARY ANALYSIS K130552." |
| Advanced MPR Batch | Workflow enhancement should result in no significant functional differences from SE K151212. | "Advanced MPR Batch is a workflow enhancement. No significant functional differences exist between SE K151212." |
| Virtual Bronchoscopy | The new functionality for "showing the route to the desired target" and "showing Virtual Bronchoscopy" should operate similarly to features legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K112051) and LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE. It should not communicate with real Bronchoscopes. | "Virtual Bronchoscopy is a new functionality added to Ziostation2. The feature of showing the route to the desired target and showing Virtual Bronchoscopy is legally marketed in SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K112051 and LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE. Other features are previously cleared in SE K151212 and CT PULMONARY ANALYSIS K130552. Virtual Bronchoscopy does not communicate with real Bronchoscope." |
| CT Lung Resection Planning | Features for "extracting bronchi and lung lobes, extracting lesions and providing the proposal for lung resection" should function similarly to legally marketed features in IQQA-BODYIMAGING SOFTWARE (K141745) and SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K130542). Other lung analysis features should align with CT PULMONARY ANALYSIS (K130552). | "CT Lung Resection Planning is a new functionality added to Ziostation2. The feature of extracting bronchi and lung lobes, extracting lesions and providing the proposal for lung resection are legally marketed in IQQA-BODYIMAGING SOFTWARE K141745 and SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS K130542. Some other lung analysis features are previously cleared in CT PULMONARY ANALYSIS K130552." |
| MR Myocardial T1 Mapping | New functionality for "analysis of myocardium MR T1 mapping" should align with legally marketed features in SYNGO MR B17 (K082427), MR-CT VVA (K140587), and ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 (K063559). It should focus on post-process analysis and not provide image scanning. | "MR Myocardial T1 Mapping is a new functionality added to Ziostation2, providing analysis of myocardium MR T1 mapping which is legally marketed in SYNGO MR B17 K082427, MR-CT VVA K140587 and ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 K063559. MR Myocardial T1 Mapping provides post process analysis and does not provide image scanning." |
| General Software Performance | Successful integration, verification, and regression testing, with identified hazards addressed by risk management. | "The Ziostation2 software package successfully completed integration testing/verification testing prior to validation. Regression testing was also performed on all functionality present on Ziostation2 prior to release. In addition, potential hazards have been addressed by the Ziosoft Risk Management process." |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on establishing substantial equivalence to predicate devices, implying that testing focused on confirming functional similarity and safety, rather than a separate clinical performance study with a distinct test set.
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 number or qualifications of experts used to establish ground truth for a test set. This type of information is typically part of a clinical performance study, which is not described here.
4. Adjudication method for the test set
The document does not describe an adjudication method for a test set. As no specific clinical test set is elaborated upon, neither is 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 mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no indication of an assessment of human readers' improvement with or without AI assistance. The submission is for an image processing application, which may include AI components, but a specific MRMC study is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not provide details about a standalone (algorithm-only) performance study. The device is an "image processing application software" intended for "trained medical professionals to supplement generally accepted methods of interpreting radiological images," implying a human-in-the-loop context.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used. Given the nature of a 510(k) summary focused on substantial equivalence to predicate devices across various image processing functions, the "ground truth" would likely be implied by the established and accepted performance of the predicate devices themselves, or by standard clinical and radiological interpretation methods. It does not mention pathology or outcomes data as explicitly used for a test set's ground truth.
8. The sample size for the training set
The document does not provide any information regarding the sample size for a training set. This information would typically be relevant for machine learning or AI components, but it is not detailed in this submission.
9. How the ground truth for the training set was established
The document does not describe how ground truth for any training set was established. Similar to point 8, this information is absent.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).