(377 days)
The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
The Nidek Advanced Vision Information System (NAVIS) is a computer technology software that collects, stores and maintains patient data information. NAVIS provides real-time review of diagnostic patient information from a number of ophthalmic medical instruments at any PC workstation. NAVIS incorporates patient data, examination data, office scheduling and billing into one system. The Nidek Advanced Vision Information System (NAVIS) contains a main core software program and a number of optional software modules that can be installed. The additional software modules support the number of application instruments that can be used with NAVIS in order to directly transfer and enhance the patient examination data. Additional software modules include the Cell Analysis Eyebank module, the Fundus Measurement module and a software module to allow for networking of several PC workstations and internet access.
The Nidek Advanced Vision Information System (NAVIS) 510(k) summary does not contain specific acceptance criteria with numerical targets. Instead, the performance data section states that "Performance testing was conducted on the Nidek Advanced Vision Information System. System and supported instrument testing was completed based on product specifications and hazard effects determined from the risk analysis. The Nidek Advanced Vision Information System performed as intended and has thus is deemed substantially equivalent to the predicate device and comparable to other ophthalmic patient database devices." This indicates a qualitative assessment against product specifications rather than predefined quantitative acceptance criteria.
The study presented is a substantial equivalence comparison to a predicate device, the AETmed Image Processing Software (K012093), and comparisons to IFA Systems ifa System device and Topcon Instruments Corporation IMAGEnet device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet product specifications | "The Nidek Advanced Vision Information System performed as intended." |
| Functional equivalence to predicate device (AETmed Image Processing Software K012093) in image processing, patient data collection, and data management. | "The Nidek Advanced Vision Information System is substantially equivalent to the AETmed Image Processing Software is terms of image processing, patient data collection and data management." |
| Comparability to IFA Systems ifa System and Topcon Instruments Corporation IMAGEnet in collecting and storing clinical data from ophthalmic instruments. | "NAVIS is also comparable to IFA Systems ifa System device and the Topcon Instruments Corporation IMAGEnet device in terms of their use in ophthalmic practice to collect and store clinical data." |
| Perform as intended for its indicated use (collection, storage, and clinical information management of patient and diagnostic data/images from computerized instruments). | "The Nidek Advanced Vision Information System (NAVIS) has been tested and found to perform as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). The performance testing description is high-level and refers to "system and supported instrument testing" based on specifications and risk analysis.
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 provided. The study focuses on substantial equivalence based on functionality and performance against product specifications, not on diagnostic accuracy requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the study does not involve a diagnostic test set requiring adjudication.
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 explicitly mentioned or conducted. The device is described as an information management system, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone software system for data management. Its performance was assessed based on its ability to collect, store, and manage data and images as intended, rather than a diagnostic algorithm's accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the diagnostic sense (e.g., pathology, expert consensus) is not applicable to this device's performance evaluation. The "ground truth" for this device's performance would be its adherence to its own product specifications and its functional comparability to predicate data management systems.
8. The sample size for the training set
This information is not provided. The device is a data management system, not a machine learning model that would typically have a "training set" in the conventional sense of AI/ML development.
9. How the ground truth for the training set was established
Not applicable, as the device is not an AI/ML system requiring a training set with established ground truth.
§ 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).