Search Results

The Discovery System is intended for use in:

-Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis.

-The measurement and analysis of corneal curvature (comeal refractive power, and cylinder axis of the cornea. The device also maps the display of the corneal shape.

• White-to-white measurements (also called WTW or horizontal corneal diameter).

-Retro-illumination imaging of the anterior segment of the eye including intraocular lens imaging.

• The measurement of pupil diameter.

-In the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from -25.0 to +15.0 diopters spherical, and astigmatism from 0.0 to ± 10.0 diopters.

The Discovery System combines a corneal topographer and an ocular wavefront aberrometer into a single, efficient system. The Discovery System combines several features to provide clinicians with detailed ophthalmic measurements. The Discovery System is designed to quickly and easily capture:

• Anterior corneal topography .
• Ocular wavefront aberrations .
• Retro-illumination images .
• Iris images .

Using near infrared (NIR) light sources for both the corneal topography and ocular wavefront aberrations permits these measurements to be taken simultaneously along the same optical axis. Retro-illuminated imaging is provided using a NIR light source reflected off the retina and optional white light and/or NIR anterior eye light sources. Iris images are captured during a retro-illumination acquisition and can optionally be captured during all other exam type acquisitions to identify eye rotations between examinations.

The provided text describes a medical device called the "Discovery System," which combines a corneal topographer and an ocular wavefront aberrometer. However, it does not contain information regarding acceptance criteria, a specific study proving the device meets those criteria, or details such as sample sizes, expert qualifications, or ground truth establishment for a study of its performance in a clinical setting.

The "Performance Data" section (Page 2) primarily discusses:

• Light source safety measurements: This involves verifying that the device's light emissions (NIR SLD, NIR LEDs, White LEDs, and combinations) meet specified international safety standards (ANSI 136.1, ISO 15004-2, IEC 62471). This is a safety assessment, not a performance assessment of its clinical diagnostic capabilities.
• System measurement performance evaluation: It states this was "evaluated using bench testing" and involved "designing and producing surfaces on a high-precision contact lens lathe for system calibration. corneal topography measurements, and ocular wavefront measurements." This describes a bench test used for calibration and internal validation of measurement accuracy on controlled targets, not a clinical study with human subjects or a comparison against human experts.

Therefore, I cannot provide the requested table and detailed information because the source document does not contain a description of a clinical study assessing the device's diagnostic performance against established acceptance criteria. The document focuses on regulatory approval (510(k) submission for substantial equivalence) and safety aspects, along with bench testing for calibration and internal performance validation.

Ask a specific question about this device