(43 days)
The IMAGEnet Professional PC Software System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks. The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
The IMAGEnet Professional PC Software System is a computerized software system that collects, stores, and manages digital images of the retina and anterior segment of the eye. The IMAGEnet Professional PC Software System is compatible with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps. The IMAGEnet Professional PC Software System is installed in a Windows 2000 or Windows XP Compatible PC to automate the functions of image capture, database archival of images, and image processing. The software includes optional functions that allow the user to stitch multiple images together or estimate the desired laser treatment size for photodynamic therapy (PDT). The Topcon IMAGEnet Professional PC Software System is intended as a software program for the use in the management of digital images acquired from diagnostic instruments that capture images of the retina and anterior segment of the eye.
I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document is a 510(k) summary for the IMAGEnet Professional PC Software System, which is a software for managing ophthalmic images.
While it mentions "Software validation testing and image capture testing were performed on the IMAGEnet Professional PC Software System" and states "Test results for the IMAGEnet Professional Software Frorem demonstrated sufficient agreement with captured images," it does not provide the specific acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods that you requested. It primarily focuses on establishing substantial equivalence to predicate devices based on intended use and basic functionality, rather than detailed performance metrics.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance: This information is not provided.
- Sample sized used for the test set and the data provenance: This information is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
- 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 device is for image management, not AI-assisted diagnosis, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a software system for image management, not an algorithm with standalone diagnostic performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided, as the validation focuses on capturing and managing images accurately, not diagnostic ground truth.
- The sample size for the training set: This information is not provided.
- How the ground truth for the training set was established: This information is not 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).