Search Results

The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic. Similar to the KOWA GENESIS, the KOWA GENESIS-D is a mydriatic retinal camera. In comparison with the KOWA GENESIS, it contains a similar optical system, and power supply system, and maintains the same level of safety performance. The KOWA GENESIS-D is similar to the Nidek Handy NM-100 in that it is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured. Both devices are equipped with highly sensitive CCD cameras, and use a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort. Compared to the predicate device, the KOWA GENESIS-D uses less power during observation by using a visible LED light for observation lighting. Various weight savings were achieved with the KOWA GENESIS-D camera to allow the user to be able to hold it in one hand with ease.

AI/ML Overview

The KOWA GENESIS-D is a hand-held retinal camera that captures and saves fundus images with mydriatic. The device's acceptance criteria are based on substantial equivalence to predicate devices, namely the KOWA GENESIS and the Nidek Handy NM-100. The study demonstrating compliance is a comparison of the KOWA GENESIS-D against these predicate devices on key functional and safety attributes.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Predicate Devices)	KOWA GENESIS-D Performance
Intended Use	KOWA GENESIS: A hand-held mydriatic fundus camera.
Nidek Handy NM-100: A hand-held non-mydriatic fundus camera which captures images of the retinal electronically.	A hand-held mydriatic retinal camera which captures fundus image. (Matches KOWA GENESIS's mydriatic capability and Nidek's electronic image capture).
Use condition	KOWA GENESIS: With mydriatic.
Nidek Handy NM-100: Without mydriatic.	Same as GENESIS (with mydriatic).
Picture angle	KOWA GENESIS: Horizontal: 30 degree, Vertical: 25 degree.
Nidek Handy NM-100: 30 degree.	Same as GENESIS (Horizontal: 30 degree, Vertical: 25 degree).
Working distance	KOWA GENESIS: 5mm.
Nidek Handy NM-100: 8mm (from the examination window to the cornea).	Same as GENESIS (5mm).
Observation	KOWA GENESIS: Visual observation.
Nidek Handy NM-100: 5 inch Color LCD.	Same as GENESIS (Visual observation).
Storage media	KOWA GENESIS: 35mm film.
Nidek Handy NM-100: Flash memory card.	Same as NM-100 (Flash memory card). This indicates an improvement over the older KOWA GENESIS film storage but aligns with the predicate Nidek's digital storage.
Camera spec.	KOWA GENESIS: 35mm film camera.
Nidek Handy NM-100: Color CCD camera, 350,000 pixels.	Color CCD camera, 2,000,000 pixels. (Improved resolution compared to Nidek Handy NM-100's digital camera, but aligns with the shift to digital imaging).
Image data format	KOWA GENESIS: N/A.
Nidek Handy NM-100: JPEG.	JPEG and uncompressed format. (Offers more flexibility than Nidek Handy NM-100's JPEG only).
Diopter compensation	KOWA GENESIS: -15D~+35D.
Nidek Handy NM-100: -15D~+35D.	Same as both (-15D~+35D).
Observation Light Source	KOWA GENESIS: Halogen lamp, 12V, 50W.
Nidek Handy NM-100: Infrared LED.	Visible LED, 4VA (approx. 1W). (More power-efficient than KOWA GENESIS halogen lamp; visible light distinguishes it from Nidek's infrared).
Photographing Light Source	KOWA GENESIS: Xenon flash lamp, 150WS.
Nidek Handy NM-100: Xenon flash lamp, 25WS.	Xenon flash lamp, 23WS. (Lower power than KOWA GENESIS, similar to Nidek Handy NM-100, which contributes to user comfort).
Power consumption	KOWA GENESIS: 400VA.
Nidek Handy NM-100: 200VA.	60VA. (Significantly lower than both predicate devices).
Weight of Camera unit	KOWA GENESIS: approx. 1kg.
Nidek Handy NM-100: approx. 1.5kg.	approx. 1kg. (Matches KOWA GENESIS, lighter than Nidek Handy NM-100, facilitating one-hand use).
Safety Performance	Same level of safety performance as predicate devices.	Maintains the same level of safety performance.
Fundamental Function	Same fundamental technology and function as predicate devices.	Equipped with the same fundamental technology and maintains the same level of safety performance. No significant differences in fundamental function or safety.

2. Sample size used for the test set and the data provenance:

The provided documentation does not detail a specific "test set" in the context of a performance study with patient data. The study is a comparative analysis of device specifications and functional characteristics against predicate devices (KOWA GENESIS and Nidek Handy NM-100). This indicates a retrospective analysis of existing device specifications and designs, rather than a prospective study involving human subjects or image data acquisition for testing. Therefore, there is no sample size of images or patient data discussed for a test set. The "data provenance" for this type of comparison would be the technical specifications and design documents of the KOWA GENESIS-D and the predicate devices themselves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The assessment is not based on a ground truth established by experts interpreting images or clinical outcomes. Instead, it's a technical and functional comparison of the device's design against other marketed devices.

4. Adjudication method for the test set:

This information is not applicable as there is no test set of clinical images or data requiring expert 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:

This information is not applicable. The KOWA GENESIS-D is a retinal camera, a medical imaging device, not an AI or computer-aided diagnosis (CAD) system. The submission does not mention any AI capabilities or a study on reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a camera, not an algorithm, and the submission does not describe any standalone algorithm performance.

7. The type of ground truth used:

The "ground truth" for this submission is based on technical specifications, functional descriptions, and safety profiles of the legally marketed predicate devices. The KOWA GENESIS-D demonstrates substantial equivalence by showing that its intended use, technological characteristics, and safety and effectiveness are similar to the predicate devices. It is a comparison against established device features, not against a clinical expert consensus, pathology, or outcomes data for diagnostic accuracy.

8. The sample size for the training set:

This information is not applicable. The KOWA GENESIS-D is a hardware device (camera), not an algorithm that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set for an algorithm.

Ask a Question

Ask a specific question about this device

Page 1 of 1