(133 days)
RESCAN 700 provides non-contact, high resolution, optical coherence tomographic (OCT) and biomicroscopic imaging of the anterior and posterior segment of the eye via an ophthalmic surgical microscope. The RESCAN 700 is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging of posterior ocular structures, including retina, macula, and optic disc, as well as imaging of anterior ocular structures, including the cornea, lens and anterior chamber angle.
RESCAN 700 uses an assistance system (CALLISTO eye) that provides non-diagnostic video documentation and image capture for ophthalmic surgeries. The assistance system allows the remote control of RESCAN 700.
RESCAN 700 brings Spectral Domain OCT technology to the Zeiss OPMI Lumera 700 ophthalmic surgical microscope. Used in conjunction with software version 3.2 of an assistance system, CALLISTO eye, OCT images taken intra operatively are presented on the monitor and may also be seen within the surgeon's oculars using the OPMI Lumera 700's integrated data injection system (IDIS). OCT images may be stored for subsequent retrieval using CALLISTO eye's data management system. RESCAN 700 can be controlled via the touch panel of the assistance system or via the foot control panel of an ophthalmic surgical microscope.
RESCAN 700 is used with CALLISTO eye software version 3.2.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the RESCAN 700 device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies against specific acceptance criteria.
The "PERFORMANCE DATA" section (page 7) briefly mentions that:
- RESCAN 700 was designed and tested to applicable standards for electrical and optical safety.
- Performance testing was conducted, and the device was found to perform as intended.
- Each function/feature was tested by an appropriate test case or specification.
- Testing demonstrated conformance to IEC 60601-1 and IEC 60601-1-2 standards.
- Software verification activities included tests accompanying development, integration tests, and system verification.
- Validation and usability testing were conducted with RESCAN 700 in conjunction with CALLISTO eye to ensure it meets product and user requirements.
However, this section does not provide:
- A table of specific acceptance criteria.
- Reported device performance against numerical targets.
- Details about sample sizes, data provenance, ground truth establishment, or expert involvement for any specific performance study.
- Information on MRMC comparative effectiveness studies or standalone performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and the study proving the device meets them based on the text provided.
§ 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.