(32 days)
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic ophthalmic cameras.
The VK-2s consists of five types of software models including the:
- VK-2s Standard .
- . VK-2s VX-20
- VK-2s nonmyd ●
- VK-2s nonmydWX
- VK-2s Viewer .
The VK-2s Standard, VK-2s VX-20, VK-2s nonmyd, and VK-2s nonmydWX are all software executed on a capture PC. The software acquires images from a retinal camera that the control software captures and puts on the capture PC. The software acquires images of the eye, stores images and processes images. The software displays acquired and processed images which are stored in a Server's database. The only difference between these four software programs are the devices that are supported for providing images:
VK-2s Standard
This software only supports images from:
- KOWA VX series cameras, ●
- KOWA nonmyd series cameras .
- and supports file import.
VK-2s VX-20
This software only supports images from:
- . KOWA VX-20 series cameras,
- and supports file import. ●
VK-2s nonmyd
This software only supports images from the KOWA nonmyd series cameras.
VK-2s nonmydWX
This software only supports images from the KOWA nonmydWX cameras.
VK-2s Viewer
This is a software executed on a viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in a server database. This software does not support image capture.
The VK-2s software also takes advantage of three software packages included with the VK-2s. These are:
VK-Montage Software
This software allows the operator to create montages using multiple images
VK-Scan
VK Scan is software which can be used to import images located in a specified folder.
VK-DDV
The detailed database viewer provides advanced searching, viewing, image processing, printing, and reporting for your VK-2s database.
This document describes a 510(k) premarket notification for the Kowa VK-2s, a Picture Archiving and Communication System (PACS) for ophthalmic images. The provided text is a summary of the 510(k) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria for device performance.
Therefore, the following information cannot be fully extracted or is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined for the Kowa VK-2s in this document. The document focuses on comparing functions and features to predicate devices to establish substantial equivalence.
- Sample sized used for the test set and the data provenance: No test set or related sample size is mentioned, as this is a comparison to predicate devices, not a new performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study information is provided.
- The type of ground truth used: No ground truth data is discussed.
- The sample size for the training set: Not applicable as no algorithm training is discussed.
- How the ground truth for the training set was established: Not applicable.
However, based on the provided text, here is what can be inferred about the device and its assessment:
1. Acceptance Criteria and Reported Device Performance:
While no numerical acceptance criteria or performance metrics are explicitly stated, the implicit acceptance criterion is "substantial equivalence" to the predicate devices. This means the Kowa VK-2s must have the "same indications for use, similar principles of operation, and similar technological characteristics" as the predicate devices, and the differences should not raise new questions of safety or effectiveness.
The "reported device performance" is a feature-by-feature comparison to predicate devices. The document highlights functional similarities and differences to argue for substantial equivalence.
Table 1: Comparison of KOWA VK-2s to Canon Ophthalmic Software Platform RX (Primary Predicate)
| Feature/Function | Proposed Device (KOWA VK-2s) | Predicate Device (Canon Ophthalmic Software Platform RX) | Differences (VK-2s vs. Canon) |
|---|---|---|---|
| Model | KOWA VK-2s | Ophthalmic Software Platform RX | - |
| Device Design | |||
| Type of Retinal Camera Image | Color | Color | - |
| Montage | - | VK-2s has Montage | |
| FAF | FAF | - | |
| FA | FA | - | |
| View Image | Single View | Single View | - |
| Full Screen (Frame Size) | Full Screen (Frame Size) | - | |
| Both Eyes | Both Eyes | - | |
| Multiple Images | Comparison | VK-2s has Multiple Images (Canon has Comparison) | |
| Loop | - | VK-2s has Loop | |
| - | Progression | Canon has Progression | |
| Drawing Function | - | Supported | Canon has supported Drawing Function |
| Image Processing | |||
| Sharpen Image | - | VK-2s has Sharpen Image | |
| Gamma Process | - | VK-2s has Gamma Process | |
| Zoom | Zoom | - | |
| RGB Filters | RGB Filters | - | |
| Enhance Image | - | VK-2s has Enhance Image | |
| Contrast | Contrast | - | |
| Analysis of RGB Color | - | VK-2s has Analysis of RGB Color | |
| Negative Image | - | VK-2s has Negative Image | |
| Edge Enhancement | - | VK-2s has Edge Enhancement | |
| Histogram Chart | - | VK-2s has Histogram Chart | |
| Flip Image | - | VK-2s has Flip Image | |
| - | Cobalt | Canon has Cobalt | |
| - | Emboss | Canon has Emboss | |
| - | Redfree | Canon has Redfree | |
| C/D Ratio | C/D Ratio | C/D Ratio | - |
| Image Measurement | |||
| Measure Distance | - | VK-2s has Measure Distance | |
| Measure Angle | - | VK-2s has Measure Angle |
Table 2: Comparison of KOWA VK-2s to KOWA portable VK-2 in KOWA nonmyd a-DIII (Secondary Predicate)
| Feature/Function | Proposed Device (KOWA VK-2s) | Predicate Device (KOWA nonmyd α-DIII) | Differences (VK-2s vs. nonmyd α-DIII) |
|---|---|---|---|
| Model | KOWA VK-2s | KOWA nonmyd α-DIII | - |
| Device Design | |||
| Type of Retinal Camera | |||
| software used in conjunction with | Mydriatic | VK-2s supports Mydriatic camera images (Predicate does not specify/implies non-mydriatic only) | |
| Non-mydriatic | Non-mydriatic | - | |
| Type of Retinal Camera Image | Color | Color | - |
| Montage | Montage | - | |
| FAF | FAF | - | |
| FA | - | VK-2s has FA image function | |
| Image Processing | |||
| Sharpen Image | Sharpen Image | - | |
| Gamma Process | Gamma Process | - | |
| Zoom | Zoom | - | |
| RGB Filters | RGB Filters | - | |
| Enhance Image | Enhance Image | - | |
| Contrast | Contrast | - | |
| Analysis of RGB Color | Analysis of RGB Color | - | |
| Negative Image | Negative Image | - | |
| Edge Enhancement | - | VK-2s has Edge Enhancement | |
| Histogram Chart | - | VK-2s has Histogram Chart | |
| Flip Image | Flip Image | - |
The key conclusion stated is that the differences "do not raise new questions of safety or effectiveness," thus satisfying the substantial equivalence requirement.
9. How the ground truth for the training set was established:
The software was subject to "Software verification and validation testing," which is a standard procedure for medical device software to ensure it performs as intended and meets its specifications. The software was considered a "moderate" level of concern. This indicates that a risk assessment was performed, and the testing was conducted according to established software development and quality assurance protocols (e.g., unit testing, integration testing, system validation). However, specific details about the methods or data used in this verification and validation are not provided in this summary. There is no mention of a "training set" in the context of an AI/ML algorithm.
§ 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).