(33 days)
The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including:
o Displaying DICOM compliant medical images and non-DICOM content using XDS
o Reformatting images. including creation of MPRs. MIPS. MinIPs. color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
o Creating individually captured DICOM images that can be displayed and stored in a PACS
o Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.
IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks.
With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments.
IBM iConnect Access was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/ level, scroll, cine, link series, line/ angle/ ROI measurements, and MPR.
The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.
The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project). MPR (multiplanar reconstruction). 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel can employ advanced image processing and display from local or remote locations.
IBM iConnect Access can be used to query retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment.
IBM iConnect Access along with IBM iConnect Enterprise Archive comprise a cloud based solution marketed as iConnect Cloud Archive. The IBM iConnect Access 3D advanced imaging solution option is not available on iConnect Cloud Archive.
The provided text is a 510(k) Summary for the IBM iConnect Access device. It does not contain specific acceptance criteria or details of a study that proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of features and stating that internal verification and validation testing confirmed product specifications.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from this document.
However, I can provide what information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of specific metrics (e.g., sensitivity, specificity, accuracy). It generally asserts that "product specifications have been met" based on internal verification and validation. The table in the "Comparison with Predicate" section outlines features and capabilities, and the rationale column often states "Substantially Equivalent."
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Overall Performance | "product specifications have been met" (through internal verification and validation testing) |
| Intended Use/Indications | "Substantially Equivalent" to predicate devices, with expanded indications and minor modifications for clarification. Mobile use not for diagnostic viewing. |
| Image Manipulation | "Substantially Equivalent" to predicate devices; RGB channel filter added, Edge enhancement and Cine evaluated as non-significant change. |
| Server Compatibility | "Substantially Equivalent" - compatible with more recent versions of Windows Server and SQL Server. |
| User Access | "Substantially Equivalent" - compatible with more recent browser versions and includes HTML5 Universal viewer support. |
| Image Rendering | "Substantially Equivalent" - provides client-side rendering for HTML5 in addition to server-side rendering. |
| Images Displayed | "Substantially Equivalent" - includes the ability to display non-DICOM images in addition to DICOM. |
| Collaboration | "Substantially Equivalent" - real-time collaboration builds upon current email connection and image rendering engine. |
| Measurement & Analysis | "Substantially Equivalent" - additional lines and Pixel Value evaluated as non-significant change in previous releases. |
| Storage & Image Transfer | "Substantially Equivalent" - addition of de-identified DICOM tags/Data Masking; XDS compliance and image transfer evaluated as non-significant change in previous releases. |
| Printing | "Substantially Equivalent" - includes the ability to print to PDF. |
| Workflow & Navigation | "Substantially Equivalent" - user can choose between old and new UI navigation; additional workflow features evaluated as non-significant change in previous releases. |
| Reports & Document Viewing | "Substantially Equivalent" - additional document viewing types evaluated as non-significant change in previous releases. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The document states "Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that IBM iConnect Access product specifications have been met." It does not specify the sample size, type of data used (e.g., patient cases, synthetic data), or its provenance for these internal tests.
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 document does not describe the establishment of a "ground truth" using experts for the purpose of validating the device's performance against clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No details on adjudication methods for a test set are 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the document. The IBM iConnect Access device is described as a Picture Archiving and Communication System (PACS) with advanced imaging capabilities, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not detail a standalone performance study in the way it might for an AI algorithm. It describes the device as providing "healthcare professional tools to aid in interpreting medical images," and explicitly states, "The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user." This indicates it's not a standalone diagnostic algorithm. The cardiac calcium scoring feature is described as "using tomographic medical image data and clinically accepted calcium scoring algorithms," suggesting it integrates existing, accepted algorithms rather than presenting a novel standalone algorithm for independent validation in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used, as it does not detail a clinical study with a defined ground truth for device performance evaluation. The "ground truth" for the verification and validation largely refers to the device meeting its own design specifications and intended functionality, and demonstrating substantial equivalence to predicate devices.
8. The sample size for the training set
The document does not provide information about a training set since it focuses on a PACS system and its comparison to predicate devices, not on a machine learning model that would require a distinct training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, this information is not applicable/provided.
§ 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).