(75 days)
The VISUCAM™ PRO NM Digital Camera is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.
The VISUCAM™ PRO NM Digital Camera is intended to capture, display and store images of the eye, especially the retinal area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. The VISUCAM™ PRO NM Digital Camera is indicated for use in non-mydriatic mode. As such, it incorporates appropriate light sources so that retinal areas of interest may be observed under non-mydriatic conditions and images may be captured with a flash illumination.
This is a premarket notification (510k) for the Carl Zeiss Meditec VISUCAM™ PRO NM Digital Camera, which is a medical imaging device (specifically, an ophthalmic camera).
The provided text does not contain acceptance criteria, a study proving device performance against acceptance criteria, or details regarding AI/algorithm performance.
A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device. In this case, the VISUCAM™ PRO NM Digital Camera is shown to be substantially equivalent to the VISUCAM™ C Digital Camera (K043222). This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device. It does not typically involve extensive clinical studies with specific performance metrics and acceptance criteria in the way an AI/ML medical device submission would.
Therefore, I cannot populate the requested table or provide answers to the questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets. These concepts are not addressed in this 510(k) submission.
The document states: "As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISUCAM™ PRO NM Digital Camera to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use." However, it does not detail what "all testing deemed necessary" entailed or any specific performance targets.
§ 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.