(15 days)
The MEDStreaming Medical Office software provides a means of opening and displaying image files.
The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server.
MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods.
The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection.
The MEDStreaming Medical Office software provides a means for querying and retrieving patient studies from a networked DICOM server device.
MEDStreaming's Medical Office provides a means to digitize video information from connected imaging modalities using a standard video digitizing engine.
The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software.
The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools.
The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device.
MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method.
MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on Medical Office utilizing Microsoft standard text, spreadsheet and database programs.
MEDStreaming's Medical Office provides a means for importing and exporting patient information in HL7 format.
MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.
The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods.
The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querving and retrieving patient studies from a networked DICOM server device.
The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software.
The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools.
The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method.
MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on the Medical Office workstation utilizing Microsoft standard text, spreadsheet and database programs.
MEDStreaming's Medical Office provides a means for export results in HL7 or standard graphic file format.
MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.
The provided document is a 510(k) summary for the MEDStreaming Medical Office software, which is a Picture Archiving and Communications System (PACS). This document does not contain information related to acceptance criteria, device performance metrics, or study details that prove the device meets specific acceptance criteria in the way described in the prompt's request (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (ProSolv Cardiovascular Viewer, Analyzer and Server) based on its functional capabilities and adherence to voluntary standards. It primarily describes the features of the software for displaying, transferring, archiving, retrieving, viewing, and processing medical image data.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study to prove acceptance criteria based on the information given. The document does not discuss performance in terms of diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI-driven diagnostic devices.
Here's what I can extract, noting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy, sensitivity, specificity). The document implies that the "acceptance criteria" are related to compliance with voluntary standards and functional equivalence to a predicate device.
- Reported Device Performance: Not reported in quantitative terms. The document only lists the features and functionalities of the software.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO JPEG Image Compression Standard | Device is designed to comply with ISO JPEG Image Compression. |
| Compliance with DICOM Standard 3.0 | Device is designed to comply with DICOM Standard 3.0. |
| Support for ICD-9 Finding Codes | Device supports ICD-9 Finding Codes. |
| Support for Exam Type CPT Codes | Device supports Exam Type CPT Codes. |
| Compliance with Health Language 7 (HL7) | Device is designed to comply with HL7. |
| Compliance with ICAVL and ICAEL standards | Device is designed to comply with ICAVL and ICAEL. |
| Interoperability with Microsoft Office Interoperability Engine | Device is designed to interoperate with Microsoft Office. |
| Ability to open and display image files | Device provides this means. |
| Ability to transfer medical image files via DICOM network | Device provides this means. |
| Ability to transfer acquired studies to DICOM compliant archive | Device provides this means. |
| Ability to retrieve and view image data from acquisition/archive | Device provides this means. |
| Ability to query and retrieve patient studies from DICOM server | Device provides this means. |
| Ability to create AVI, BMP, and JPG graphic files | Device provides this means. |
| Ability to quantify image data using standard measurement tools | Device provides this means. |
| Ability to transfer DICOM Structured Reporting components | Device provides this means. |
| Ability to transfer labeled measurements via serial gateway | Device provides this means. |
| Ability to generate examination reports | Device provides this means. |
| Ability to export results in HL7 or standard graphic file format | Device provides this means. |
| Ability to generate utilization reports | Device provides this means. |
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not mentioned. This device is a PACS system, not an AI diagnostic algorithm, so such a study would not be expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a PACS system, not a standalone AI algorithm. Its performance is related to its functionalities as an image management and display system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/mentioned. The evaluation described is based on functional compliance and substantial equivalence to a predicate, not diagnostic accuracy requiring ground truth.
8. The sample size for the training set: Not applicable/mentioned, as this is a PACS system and not an AI/ML model requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable/mentioned.
§ 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).