(165 days)
The Topcon Model TRC-NW200 Non-Mydriatic Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eyecare professional, without the use of a mydriatic.
The Topcon TRC-NW200 is a non-mydriatic ophthalmic camera that captures and displays images of the eye. The images are captured by using halogen illumination with an infrared filter for observation and a xenon flash bulb for photography. There is no laser illumination. Alignment dots and focusing bars assist the operator in properly positioning the camera. The operator presses a button on the top of the joystick to capture the image. The image is then displayed on the built-in LCD display or, if desired, transferred to a personal computer.
The provided text {0} to {4} describes a 510(k) submission for the Topcon TRC-NW200 Non-Mydriatic Retinal Camera. However, this document does not contain information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about ground truth, sample sizes for testing/training, or expert involvement.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than providing performance metrics against predefined acceptance criteria.
Therefore, I cannot fulfill your request for the tables and detailed information you’ve asked for based on the provided text. The document primarily covers:
- Device Name, Classification, and Submitter Information
- Identification of Predicate Devices
- Description of the Device and its Intended Use
- A statement of Substantial Equivalence outlining that the device has the same intended use, indications, principles of operation, and technical characteristics as the predicates.
- FDA's response letter confirming the substantial equivalence determination and allowing the device to be marketed.
- Indications for Use Statement
There is no mention of specific performance metrics, clinical studies, or data analysis concerning the device's accuracy or effectiveness in capturing images of the retina. The focus is on demonstrating that it functions similarly to previously cleared devices.
§ 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.