(37 days)
The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.
The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with
The provided text is a 510(k) summary for the Bioptigen Spectral Domain Ophthalmic Imaging System. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence. However, the document explicitly states that clinical tests were "Not required" and therefore does not contain information about acceptance criteria or a study proving the device meets those criteria using expert review of clinical data.
The device gained clearance based on non-clinical tests demonstrating conformance to safety and performance standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2) and a technological comparison to predicate devices, showing that differences in resolution, acquisition rate, and internal fixation did not raise new questions of safety and effectiveness.
Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical performance evaluations which were not conducted or reported for this submission.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical performance study was conducted or required for this 510(k) submission, there are no acceptance criteria related to a specific clinical performance metric (e.g., sensitivity, specificity, accuracy against a clinical ground truth). The "performance" described pertains to technical specifications compared against predicate devices.
| Specification | Acceptance Criteria (Predicate) | Reported Device Performance (Bioptigen SDOCT) |
|---|---|---|
| Optical power |
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.