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KOWA GENESIS-Df is a hand-held mydriatic retinal camera which captures fundus image. 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. It uses a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort. Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting. Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease.

AI/ML Overview

This 510(k) notification describes a device (KOWA GENESIS-Df) that is substantially equivalent to a predicate device (KOWA GENESIS-D). The acceptance criteria and supporting study information are therefore focused on demonstrating this substantial equivalence, rather than establishing de novo performance metrics for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (KOWA GENESIS-Df)
Intended Use	Device is intended to capture and save fundus images with mydriatic.	Meets Criteria: The KOWA GENESIS-Df is intended to capture and save fundus images with mydriatic. This is identical to the predicate device's intended use.
Fundamental Technology	Device employs fundamental technology similar to the predicate device.	Meets Criteria: KOWA GENESIS-Df uses the same basic structures (e.g., highly sensitive CCD camera, immediate image viewing, lower flash light intensity for comfort) as the KOWA GENESIS-D. The primary changes are enhancements (improved optical system for fluorescence angiography, electrical circuit and capacitance enlargement).
Safety Performance	Device maintains a level of safety performance equivalent to the predicate device.	Meets Criteria: Evaluation of light hazard, electrical safety, and EMC was performed. It was checked that device safety is a level equivalent to KOWA GENESIS-D. The device uses a visible LED light for observation, similar to the predicate, and a Xenon flash lamp for photography (23WS, same as predicate, but with an improved optical system for fluorescence). The maximum rated flash bulb from the predicate is used.
Functionality Comparison	All key functional specifications (use condition, picture angle, working distance, observation, storage media, camera spec., image data format, diopter compensation, observation light source, photographing light source, power consumption, weight) are either identical ("SAME to GENESIS-D") or represent an improvement while maintaining essential equivalence.	Meets Criteria:

Intended Use, Use Condition, Picture Angle, Working Distance, Observation, Storage Media, Camera Spec., Image Data Format, Diopter Compensation, Observation Light Source, Weight of Camera unit: All are explicitly stated as "SAME to GENESIS-D".
Photographing Light Source: Xenon flash lamp 23WS (same as predicate) but "with improved optical system" for fluorescence angiography. This is an enhancement within a substantially equivalent framework.
Power Consumption: 150VA (higher than predicate's 60VA) due to enlarged power supply for fluorescence function, but this change was evaluated for safety. |

2. Sample Size Used for the Test Set and the Data Provenance

This 510(k) notification does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic accuracy or performance against a ground truth dataset of patient images. Instead, it focuses on technical and safety comparisons to a predicate device.

Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The submission relies on technical specifications, engineering comparisons, and safety/EMC testing.
Data Provenance: Not applicable for patient data. The provenance relates to engineering test data and specifications, likely from Kowa Company, Ltd. (Japan) where the device is manufactured and designed. The submission itself is prospective, detailing a new device based on an existing one.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission does not involve evaluation of diagnostic performance against expert-established ground truth. The "ground truth" for the claims made in this document relates to the technical specifications and safety profile of the predicate device, against which the new device is compared. This would involve internal engineering expertise at Kowa Company, Ltd.

4. Adjudication Method for the Test Set

Not applicable, as no clinical "test set" was described for diagnostic performance evaluation.

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

Not applicable. This device is an ophthalmic camera, not an AI-powered diagnostic tool. The submission is a 510(k) for substantial equivalence based on hardware and functional comparison, not a comparative effectiveness study involving human readers or AI.

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

Not applicable. This is a hardware device (ophthalmic camera) and does not involve a standalone algorithm for diagnostic or screening purposes.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established technical specifications, safety data (light hazard, electrical safety, EMC), and functional performance of the predicate device, KOWA GENESIS-D (K050271). The new device (KOWA GENESIS-Df) is compared directly against these documented characteristics to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI algorithm being trained as part of this device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

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