EYECAP IMAGING SYSTEM

• K Number: K000368
• Device Name: EYECAP IMAGING SYSTEM
• Manufacturer: CLEMENT CLARKE INTL., LTD.
• Date Cleared: 2000-05-04 ( 90 days)
• Product Code: HKI
• Regulation Number: 886.1120
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The EyeCap Imaging System is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps.

Device Description

EyeCap Imaging System

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the EyeCap Imaging System, which primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table or answer the specific questions about the study, sample sizes, ground truth, or expert qualifications.

Regulation Number and Section

§ 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.