(94 days)
The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.
The OTI OCT Ophthalmoscope produces simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. In addition conventional longitudinal OCT images may also be collected. The system uses a high power superluminescient diode operating at 850nm. The software uses a tabbed interface: the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen. When there are several major components in a function, these are presented as tabs below the principal tab bar.
The provided text is a 510(k) summary for the OTI OCT-Ophthalmoscope. It describes the device, its intended use, and states that no clinical tests were required for its clearance. Therefore, a study demonstrating the device meets acceptance criteria, as well as several other requested details, cannot be found in this document.
The document states:
- (b) Clinical tests: Not required.
- (c) Conclusions: The OCT-Ophthalmoscope is equivalent in safety and efficacy to the legally-marketed predicate device.
This indicates that the device's clearance was based on demonstrating substantial equivalence to pre-existing legally marketed devices (K012727, K943956) through non-clinical tests (accuracy, optical emissions analyses, electrical safety tests, and software validation tests), rather than a clinical study with acceptance criteria for device performance.
Therefore, the following information cannot be provided from the given text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information on standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical study.
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 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.