(188 days)
The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF). The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor. The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.
The KOWA VX-20 is a retinal image shooting device. The provided text describes the performance testing conducted to ensure its safety and effectiveness.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO10940 (General Standard for Ophthalmic Instruments) | KOWA VX-20 met all requirements of the standard. |
| IEC60601-1 (Electrical Safety) | KOWA VX-20 met all requirements of the standard. |
| IEC60601-1-2 (Electromagnetic Compatibility) | KOWA VX-20 met all requirements of the standard. |
| ISO15004-2 (Optical Safety) | KOWA VX-20 met all requirements of Group 2 instrument in the standard. |
| FDA Guidance: "Guidance for the content of premarket submissions for software contained in medical devices, 2005" (Software Validity) | All functions are tested and confirmed good working to required items; software level of concern is moderate. |
| Biocompatibility Assessment (Material Safety) | Materials used were the same as other legally marketed devices in the US or evaluated under Material Safety Data Sheet (MSDS). |
| ISO14971:2007 (Risk Management) | The risk management of the device was deemed satisfactory. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a particular "test set" in terms of subject or image count for performance validation. Instead, the device's performance is demonstrated through adherence to various international and FDA standards, which typically involve testing the device itself rather than its performance on a dataset. The studies described are engineering and safety compliance tests, not clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" here is compliance with technical standards, which is assessed through testing procedures defined by those standards, not through expert review of clinical data.
4. Adjudication Method for the Test Set
Not applicable. Technical standard compliance is determined by test results against predefined limits, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not performed. The submission focuses on device safety and technical performance, not on demonstrating improved human reader performance with the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The testing described for electrical safety, electromagnetic compatibility, optical safety, and software validation are assessments of the device's standalone performance against established technical and safety standards. There is no "algorithm only" performance reported in the context of an AI-powered diagnostic system, as this device's primary function is image acquisition.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on technical standards and regulations. This includes:
- Specifications and requirements outlined in ISO10940, IEC60601-1, IEC60601-1-2, ISO15004-2.
- FDA guidance for software validation.
- Material safety data.
- Risk management principles from ISO14971:2007.
8. The Sample Size for the Training Set
Not applicable. This device is an image acquisition device, not an AI model requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
§ 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.