(46 days)
The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists.
Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review.
The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution.
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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
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This document is a 510(k) clearance letter for the Cerner ProVision™ Workstation, dating back to 2007. It's important to note that 510(k) clearances typically do not require specific clinical study data to demonstrate safety and effectiveness beyond substantial equivalence to a predicate device. The focus is on showing the new device is as safe and effective as a legally marketed device, not necessarily on proving absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval) application.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is generally not included in a 510(k) clearance letter unless it was part of the substantial equivalence argument, which is rare for devices like a PACS workstation whose primary function is displaying images. The letter confirms substantial equivalence but doesn't detail the performance testing that might have been part of the manufacturer's internal verification and validation.
Based on the provided text, I can extract the following information relevant to the device and its intended use:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the 510(k) clearance letter. The letter focuses on regulatory clearance for substantial equivalence, not detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the 510(k) clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the 510(k) clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the 510(k) clearance letter.
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:
This information is not present in the 510(k) clearance letter. Given the device is a PACS workstation, not an AI diagnostic tool, a MRMC study focused on AI impact would not be expected.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The letter states: "The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution." This indicates the workstation itself can operate in a standalone manner, meaning it's a complete system for image handling. It does not refer to a standalone algorithm without a human-in-the-loop for image interpretation. The device is a display and manipulation tool for clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the 510(k) clearance letter.
8. The sample size for the training set:
This information is not present in the 510(k) clearance letter.
9. How the ground truth for the training set was established:
This information is not present in the 510(k) clearance letter.
Summary of what can be gleaned from the document:
- Device Name: Cerner ProVision™ Workstation
- Regulation Number: 21 CFR 892.2050
- Regulation Name: Picture archiving and communications system (PACS)
- Regulatory Class: II
- Product Code: LLZ
- Indications for Use: The software application is intended for rendering, visualization, and manipulating medical images to support the image display needs of clinicians, diagnosticians, and technologists. Application capabilities enable primary diagnostic review, interpretation, and distribution viewing for physician review.
- Important Caveat for Mammography: "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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." This is a crucial safety control related to the display of mammographic images.
- Intended Use Environment: Can be used standalone or as part of a unified RIS/PACS solution.
The letter's purpose is to confirm that the device is substantially equivalent to legally marketed predicate devices, not to detail the performance studies typically associated with novel diagnostic algorithms or AI.
§ 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).