(25 days)
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.
| Acceptance Criteria (Features/Characteristics) | Reported Device Performance (KOWA GENESIS-D with indirect diagnostic lens holder) | Explanation/Proof |
|---|---|---|
| Intended Use (Capture & save fundus images with mydriatic) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Use Condition (with mydriatic) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Picture Angle (Horizontal: 30 deg, Vertical: 25 deg) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Working Distance (5mm) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Observation (Visual observation) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Storage Media (Flash memory card) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Camera Spec. (Color CCD, 2M pixels) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Image Data Format (JPEG & uncompressed) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Diopter Compensation (-15D to +35D) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Observation Light Source (Visible LED, 4VA) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Photographing Light Source (Xenon flash, 23WS) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Optional Goods (Indirect diagnostic parts, K9L-LH51) | Indirect diagnostic parts, K9L-LH51 (this is the addition) | This is the specific modification being submitted for. The predicate explicitly states "Not applicable" for this field, highlighting the change. |
| Power Consumption (60VA) | Same | Stated explicitly in Table B: "Same" as predicate. |
| Weight of Camera Unit (approx. 1kg) | Same | Stated explicitly in Table B: "Same" as predicate. |
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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was performed.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable. This is not a machine learning/AI device, and no training set was used.
- 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.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.