(260 days)
RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.
RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.
The provided text is a 510(k) Summary for the RetiCapture ophthalmic camera. It outlines the device's technical characteristics and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop performance study.
The document focuses on:
- Device Description: A hand-held digital ophthalmic camera.
- Intended Use: To record digital photographs and video of the fundus of the human eye and surrounding area.
- Technical Characteristics: Comparison of specifications (FOV, Resolution, etc.) with a predicate device (MiiS Horus Scope DEC 100).
- Non-clinical tests: Performance according to various IEC and ISO standards related to safety, electromagnetic compatibility, photobiological safety, risk management, software validation, and ophthalmic instruments.
Therefore, I cannot provide the detailed information requested in the prompt based solely on the provided text. The requested information regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for AI models is not present in the given document.
The document only states that "Extensive software testing and validation have been conducted to ensure that RetiCapture performs to acceptable level, repeatedly and reliably referring to consensus standard IEC 62304:2006 and ISO 14971:2012." This refers to software engineering practices and risk management, not a clinical performance study with defined acceptance criteria for image quality or diagnostic accuracy.
To fulfill your request, I would need a different document that details the clinical or performance validation studies, including specific acceptance criteria and the results of those studies.
§ 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.