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The Orbscan II is a non-invasive, diagnostic system that measures and displays the anterior segment geometry of the eye. The system consists of an optical head, power supply and CPU. The optical head projects light through moving slit shaped apertures, The slit images are projected onto the eye at equi-distant angles from a central optical axis. A video camera placed on the optical axis records the images of the slits as they pass over the eye. The location of each slit at each position is determined during the system calibration.

During an examination, the slits are stepped across the cornea and an image of the cornea at each slit location is recorded, The CPU processes the images by using edge detection algorithms to determine the location of all of the edges the light strikes during the exam. Through direct triangulation, the elevation and curvature for the various surfaces is determined. Corneal thickness, anterior chamber depth and clevation of the iris and lens can then be determined by subtracting the surfaces.

This anterior segment information is displayed graphically to a user in the form of colored maps. These maps display variations in height and thickness numerically as well as with gradations in color. The graded colors allow for easier visualization of true measurements and how they relate to elevation and thickness of the eye geometry. The maps can be displayed individually or in several combinations. They can also be customized by the user for their specific examination needs. The Orbscan operates on a Windows™ based user interface and operating system that allows for ease of operation and system control. The CPU used with the Orbscan is a standard, high-speed PC type computer. Other peripherals may include a display monitor, a mouse pointing device and a printer for hard copies of the maps, should the user desire them.

To enhance repeatability, an optional placido pattern can be attached to the Orbscan. The placido pattern provides slope data for the anterior surface of the eye. The slope data obtained from using the placido pattern is combined with the elevation data as measured with triangulation. Tests on both test objects and human subjects have shown that the reproducibility has been enhanced from +/- . 005mm without the placido to +/-.003 mm with the placido pattern.

The device is non-invasive and only contacts the patient on his/her chin and forehead. The other concerns for safety are the light output and electrical safety. The light output is of an evesafe intensity and wavelength. Electrical safety is provided by packaging which is compliant to accepted safety standards, and mcdically safe power sources which isolate the patient from hazardous voltages and current.

The device is proven effective in incasuring the anterior geometry of the eve through internal company and independent clinical studies.

AI/ML Overview

Here's an analysis of the Orbscan II Keratometer's acceptance criteria and the study reported to show it meets those criteria, based on the provided document:

Orbscan IITM Keratometer Performance Study Analysis (K984443)

1. Acceptance Criteria and Reported Device Performance

The primary performance metric highlighted and improved upon for the Orbscan II is its reproducibility.

Acceptance Criteria / Performance Metric	Predicate Device Performance (Orbscan)	Orbscan II Reported Performance	Notes
Reproducibility	+/- 0.025 mm	+/- 0.003 mm	The improved reproducibility of +/- 0.003 mm is achieved with the optional placido pattern attached. Without the placido, the reproducibility is stated as +/- 0.005mm. The predicate device's figure is likely without a placido equivalent.
Field of view	10 x 14 mm	Same	No change noted.
Axis range	0 to 360 degrees	Same	No change noted.
Dioptric range	9 to 99 Diopters	Same	No change noted.
Resolution	0.10 Diopters	Same	No change noted.
Processing Time	~3-5 min (anterior corneal surface)

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