(38 days)
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Multi Modality Viewer is a medical image viewer software application, available on the Vitrea software platform cleared by K150258. The application allows qualified clinicians, including physicians, radiologists and technologists, to display, navigate, manipulate and quantify medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT modalities.
The Multi-Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
The provided document, a 510(k) summary for the "Multi Modality Viewer" software, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for new features that would typically involve a performance study.
The device is an update to an existing medical image viewer, and the clearance is based on the argument that new features (support for additional modalities like PET, PET/CT, CR, DX, RG, RF, XA) do not raise new questions of safety and effectiveness because similar functionalities exist in previously cleared reference devices.
Therefore, the document explicitly states: "The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software."
However, it does mention "Verification and Validation" activities and "Performance Standards" in a general sense. Based on the provided text, I can extract the following information about general testing and the device's performance, as much as is available:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no specific quantitative acceptance criteria or detailed performance metrics are provided for the new features in the context of a dedicated performance study, the "acceptance criteria" here are inferred from the general statements about software development and verification. The device's "performance" is reported as meeting these general standards.
| Acceptance Criteria (Inferred from General Software Practices) | Reported Device Performance (as stated in the document) |
|---|---|
| Feature functions according to its requirements. | "Verification confirmed that the feature functions according to its requirements." |
| Operates on the Vitrea software platform without degrading existing functionality. | "Software testing was completed to ensure the Multi Modality Viewer software functions according to its requirements and operates on the Vitrea software platform without degrading the existing functionality of the Vitrea software platform." |
| Meets all product release criteria. | "The Multi Modality Viewer software has achieved all product release criteria." |
| Risks are reduced as low as possible and probability of occurrence of harm is "Improbable." | "Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of at least 'Improbable.'" |
| Unresolved defects do not compromise safety and effectiveness. | "Of the unresolved defects remaining in the released application, each has been carefully evaluated and it has been determined that the software can be used safely and effectively." |
| Medical benefits outweigh residual risk. | "The medical benefits of the device outweigh the residual risk for each individual risk and all risks together." |
| Compliance with DICOM standard for transfer and storage of data. | "The Vitrea software platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances." |
| Compliance with recognized consensus standards (IEC 62304, ISO 14971, NEMA PS 3.1-3.20). | "The Multi Modality Viewer software complies with the following voluntary recognized consensus standards: PS 3.1- 3.20 (2011), ISO 14971:2007, IEC 62304:2006." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" with a particular sample size for a performance study related to the new features. The testing mentioned is "internal verification and external validation" which included "simulated usability testing by experienced professionals." No details about the number of cases or data provenance (country of origin, retrospective/prospective) for these tests are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No specific number of experts or their detailed qualifications are provided for establishing ground truth for a test set. The document refers to "experienced professionals" for "simulated usability testing."
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1, none) is mentioned as no specific performance study test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study is mentioned. The document explicitly states: "The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a medical image viewer software. Its function is to display, navigate, manipulate, and quantify medical images for clinicians. It is not an algorithm that performs automated detection or diagnosis. Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable and is not mentioned. Its performance is intrinsically tied to human interaction.
7. The Type of Ground Truth Used:
As no specific performance study with a dedicated test set is described, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The validation focuses on the software's ability to function as intended and display data from new modalities accurately, which relies on adherence to standards and internal software verification.
8. The Sample Size for the Training Set:
This device is image viewer software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Therefore, no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this type of device, this information is not applicable.
§ 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).