(111 days)
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is intended for use in capturing images of the retina and the anterior segment of the eye. This fundus camera can transfer images to a personal computer.
Nidek Co., Ltd. has developed the Model NM-1000, which is a stationary-type ophthalmic non-mydriatic fundus camera. Without using 35mm or instant films, this fundus camera incorporates a full digital video capturing system with memory functions, and can transfer captured images to a personal computer. The NM-1000 is designed to deliver its full performance as a fundus camera specializing in digital video capturing as a stand-alone unit or in combination with an image filing system.
In the same manner as other conventional fundus cameras, the Model NM-1000 fundus camera projects the fundus using invisible infrared beams of light during alignment and monitors patient's eye using an infrared video system which does not burden the patient's eye. As a high-sensitivity CCD chip captures an image during use, only a very small amount of flash is used as compared to the flash intensity used with instant film, therefore only giving a mild shock to the patient. The Model NM-1000 fundus camera can capture images with a very low amount of light as compared to a conventional fundus camera that uses an instant film.
The Model NM-1000 fundus camera design incorporates the camera unit and power unit into a single integrated table-top unit. During alignment, the camera displays (on the video monitor) patient ID number, as well as focusing functions such as a working distance detection spot and the focusing indicator.
The captured image is temporarily saved in the camera unit just after being captured, and is displayed as a color still image on the video monitor in real time. This allows the operator to immediately judge if the captured image is satisfactory or not. Furthermore, a large-scale 6.4-inch LCD display is used to enhance ease of operation.
Various terminals are provided to allow the operator to output and use the temporarily saved images for various purposes. The Model NM-1000 fundus camera can interface with other devices through the use of a USB port, RGB analog output and composite video output (NTSC) connections.
The Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera. The acceptance criteria and the study performed to prove the device meets these criteria are outlined below.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Met all requirements of EN 60601-1 |
| Electromagnetic Compatibility | Met all requirements of EN 60601-1-2 |
| Programmable Electrical Medical Systems | Met all requirements of EN 60601-1-4 |
| Ophthalmic Instrument Standards | Met all requirements of ISO 15004 |
2. Sample Size for the Test Set and Data Provenance:
The provided document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation. The testing performed focused on electrical safety, electromagnetic compatibility, programmable electrical medical systems, and ophthalmic instrument standards. These types of tests typically do not involve patient data or retrospective/prospective studies.
3. Number of Experts and Qualifications:
Not applicable. The study did not involve expert review or establishment of ground truth by clinical experts, as it focused on engineering and performance standards rather than clinical diagnostic accuracy.
4. Adjudication Method:
Not applicable. There was no clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted. The device is a fundus camera, a tool for capturing images, and the study focused on its adherence to safety and performance standards. It was not designed to assess human reader improvement with AI assistance (as the device itself is a camera, not an AI diagnostic tool).
6. Standalone Performance Study:
A standalone performance study was conducted in the sense that the device was tested on its own against various engineering and performance standards (EN 60601-1, EN 60601-1-2, EN 60601-1-4, ISO 15004). This was an "algorithm only" or "device only" performance evaluation against established technical benchmarks.
7. Type of Ground Truth Used:
The ground truth for the evaluations were the specific requirements and standards outlined in:
- EN 60601-1 (Electrical Safety)
- EN 60601-1-2 (Electromagnetic Compatibility)
- EN 60601-1-4 (Programmable Electrical Medical Systems)
- ISO 15004 (Test Requirements and Test Methods for Ophthalmic Instruments)
These standards define objective technical and performance criteria for the device.
8. Sample Size for the Training Set:
Not applicable. The document describes the product as a fundus camera and does not mention any machine learning or AI components that would require a "training set" for model development. The focus was on demonstrating compliance with technical standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for machine learning was used. The ground truth for the device's performance was established by international and European standards for medical device safety, electromagnetic compatibility, and ophthalmic instrument performance.
§ 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.