(275 days)
Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.
Huvitz Imaging System (HIS-5000U) consists of slit lamp camera (HIS-5000L (10.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software (HIS-5000N). It is a digital imaging system with a high resolution digital camera and PC based patient diagnostic data management software intended for controlling digital imaging devices, acceptance, transfer, display, storage and digital processing of ophthalmic images including videos, acquired from a of a slit lamp camera through direct connection or network. The imaging software (HIS-5000N) supports networking function to share patient information and examination images between multiple PCs existing on the local network or internet via TCP/IP protocol. Also, this version uses MS-SQL server solution as more reliable database, and includes additional HIS Server Management software to support to back up or restore patient and imaging data. HIS-5000N imaging system software is not able and intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings.
The Huvitz Imaging System (HIS-5000U) is intended for controlling digital imaging devices and for the acceptance, transfer, display, storage, and digital processing of documented ophthalmic images and videos, acquired from a slit lamp camera.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Report) | Reported Device Performance |
|---|---|
| Functional Performance: | The Huvitz Imaging System (HIS-5000U) performed as intended. |
| Camera Image capture | Tested and validated. |
| Saving image file | Tested and validated. |
| Adjust color of capture image | Tested and validated. |
| Measurement of figures (pixels and mm) | Tested and validated. The device has a function to measure pixels and mm. (Also, function for brightness, contrast, sharpness; function to highlight features; function to add test notes; function to search medical records; function to export/import data; function to print; function to compare images side-by-side). |
| Camera resolution & data transfer speed | Tested and validated as per the manufacturer's performance report. (Specific resolution/speed not provided in the document, but performance was confirmed against specifications). |
| Safety and Effectiveness: | The device "introduces no new concern for safety and effectiveness" based on non-clinical tests. |
| Substantial Equivalence: | The device is deemed substantially equivalent to the predicate device, EyeSuite Imaging (K142423), based on non-clinical tests and comparison of technological characteristics (Memory, Graphic Card, Operating System, Interface, Monitor resolution, how to store patient data, type of images/video format, ability to control camera, ability to manage/store/process/display patient data, type of system for viewing/modifying data, functions for notes, highlighting, enhancement, measurement, search, export/import, print, and image comparison). The primary differences noted were the operating system (Windows 7 vs. Vista/XP), memory (2048MB vs 1GB), graphic card (512MB vs 120MB), monitor resolution (1920x1080 vs 1280x800), interface (USB 2.0 vs DICOM PACS), and DICOM interface absence. |
| Intended Use: | Matches the intended use: "controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network." |
| No Diagnostic Capability (Limitation): | "Huvitz-5000N imaging system software is not able and intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings." (This is a condition/limitation, not an acceptance criterion to be met, but an explicit statement about its function.) |
Study Proving Device Meets Acceptance Criteria:
The study was a non-clinical performance testing along with a comparison to a predicate device.
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2. Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or image count. The performance testing was conducted on the Huvitz Imaging System (HIS-5000U) itself, focusing on its functionalities and adherence to product specifications.
- The data provenance is not explicitly mentioned as involving clinical data. The tests are described as non-clinical.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study was non-clinical performance testing of the device's functions, not a diagnostic accuracy study requiring expert ground truth on patient cases.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was not a study involving human reader interpretation or diagnostic outcomes on a test set.
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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:
- No MRMC comparative effectiveness study was done. The device is an imaging system for display and management, not an AI-assisted diagnostic tool for human readers.
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6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance testing was done on the "Huvitz Imaging System (HIS-5000U)" as a standalone device. The device itself (software and hardware components) was tested for its intended functions. The software "is not able and intended to provide any diagnosis."
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical performance tests would be the device's own product specifications and design requirements. The functions (image capture, saving, color adjustment, measurement, resolution, data transfer speed) were verified to work as defined by the manufacturer's standards.
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8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set of data.
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9. How the ground truth for the training set was established:
- Not applicable, as there was no training set.
§ 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).