(230 days)
KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to an image filing device through serial interface.
The KOWA nonmyd WX is a retinal camera without mydriatic. Plane retinal image capturing function, that is normal image capturing, is equipped and furthermore, stereo image capturing function is done. The stereo images are able to take simultaneously in shingle shot, as these images are captured without image/parallax shifts.
The KOWA nonmyd WX consists of a device body and external digital SLR camera, Single-Lens Reflex camera.
The KOWA nonmed WX uses Xenon flash lamp as an image capturing light and Infrared LED lamp as an observation light.
The KOWA nonmyd WX can be sued even in case which pupil has not been completely dilated in plane image capture mode, if it is more than 3.7mm in diameter.
The KOWA nonmyd WX is equipped with a USB port to be able to transfer images to a computer.
The KOWA nonmyd WX is designed to be able to link up to a filling system (KOWA portable VK-2), which can manage the digital images.
This 510(k) summary for the KOWA nonmyd WX is for an ophthalmic camera and does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML powered device. The studies described are for electrical safety, electromagnetic compatibility, optical safety, software evaluation, biocompatibility, and risk management, which are standard regulatory requirements for medical devices but do not involve performance metrics like sensitivity, specificity, or human-in-the-loop improvements typically associated with AI/ML systems.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Met all requirements of IEC60601-1 standard |
| Electromagnetic Compatibility | Met all requirements of IEC60601-1-2 standard |
| Optical Safety | Met all requirements of Group 1 instrument in ISO15004-2 standard |
| Software Validity | All functions tested and confirmed good working to required items (based on FDA guidance for software in medical devices, 'minor' level of concern) |
| Biocompatibility | All materials used same as other legally marketed devices in US |
| Risk Management | Met all requirements of ISO14971:2007; deemed satisfactory |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes compliance with electrical, optical, and software standards, not a clinical performance study using a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" here relates to engineering standards and software functionality, not clinical diagnoses made by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No MRMC study was mentioned. The device is a camera, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an ophthalmic camera, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The software evaluation confirmed the embedded software and filing software's validity as part of system function tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed relates to:
- Electrical Safety: Standards set by IEC60601-1.
- Electromagnetic Compatibility: Standards set by IEC60601-1-2.
- Optical Safety: Group 1 instrument requirements in ISO15004-2.
- Software Validity: Requirements outlined in FDA guidance for software in medical devices and internal system functional specifications.
8. The sample size for the training set
Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.