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The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

Here's a summary of the acceptance criteria and study information based on the provided text, though it's important to note that the document is a 510(k) submission for a modification, not a detailed clinical study report with performance metrics in the typical sense.

The core of this submission is a comparison to a predicate device, arguing substantial equivalence rather than presenting new performance data for specific clinical metrics.

Description of the Device and Modification:

The device is the KOWA GENESIS-D, a hand-held mydriatic retinal camera intended to capture and save fundus images. The specific submission (K080681) is for a modification: the addition of an indirect diagnostic lens holder (K9L-LH51) as an optional accessory to the previously cleared KOWA GENESIS-D (predicate device K0530271).

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate):

The "acceptance criteria" in this context are implicitly that the modified device (KOWA GENESIS-D with indirect diagnostic lens holder) performs equivalently in its intended use as the original KOWA GENESIS-D. The submission argues that the modification (the lens holder) does not change the fundamental technology, safety, or effectiveness of the device.

Study Details:

The provided document does not describe a clinical performance study in the typical sense (e.g., measuring sensitivity, specificity, accuracy against a reference standard). Instead, it's a 510(k) premarket notification focused on demonstrating substantial equivalence to a predicate device. This means the "study" is a comparison of technical specifications and intended use.

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The "test" consists of comparing specifications. The data provenance for the original device (K0530271) is not in this document.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth was performed for this submission. The "ground truth" here is that the modified device has the same properties as the predicate device, which is established by the manufacturer's engineering comparison and verification.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was performed.
4. 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 is not an AI/CADe device, and no MRMC study was conducted.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device. It's a medical imaging hardware device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical performance study. The "truth" for this submission is that the technical specifications of the modified device are the same as the predicate, which is a manufacturing and design verification process.
7. The sample size for the training set: Not applicable. This is not a machine learning/AI device, and no training set was used.
8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of the "Study" (Substantial Equivalence Argument):

• Objective: To demonstrate that the KOWA GENESIS-D hand-held retinal camera with the addition of the indirect diagnostic lens holder (K9L-LH51) is substantially equivalent to the predicate device (KOWA GENESIS-D without the accessory).
• Methodology: A direct comparison of technical specifications, intended use, operating principles, basic design, materials, power supply, light source, and packaging was conducted between the modified device and the predicate.
• Conclusion: The submitter concluded that the KOWA GENESIS-D with the indirect diagnostic lens holder shares the "same fundamental technology and maintain the same level of safety performance" as the predicate device, therefore having "no significant differences in the technological characteristics and safety." The FDA concurred with this assessment, hence the 510(k) clearance.

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The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

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.

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

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.

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