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The UD-1000 A/B Scanner is indicated for:

• Ultrasound imaging of the eye and orbit
• Producing axial measurements of the eye
• Imaging the intraocular anatomy and pathology of the eye
• Imaging the anterior segment of the eye
• Imaging the anterior angle for Glaucoma Management
• Imaging of other structures of the anterior chamber

This instrument is designed as an ophthalmic diagnostic instrument that performs both Amode and B-mode ultrasound. In B-mode, the instrument acquires an ultrasonic crosssectional image of echoes from ocular structures. The brightness of the various dots in the two-dimensional image depends on the intensity of the echo sources. In A-mode, the instrument provides a one-dimensional display of returning echoes. Positive waves indicate the location of ocular structures; the distances between spikes can be measured.

The B-scan probe transmits focused ultrasonic waves into the eyeball. The transducer oscillates back and forth, resulting in a two-dimensional cross-sectional image view of the ocular structures. The image represents a "slice" through the portion of eye that is being examined. The ultrasonic beam focus range is controlled by six annular oscillators that are arranged concentrically. Multiple images can be saved and played back at the most appropriate resolution.

The B-scan probe is used to indirectly measure axial length based on a linear sampling of the image of the eye. Although this measurement is less accurate than axial length measurement by A-scan biometry, it provides a useful approximation in patients unable to maintain a steady primary gaze or in eyes with dense cataract, detached retina or posterior staphyloma.

The A-scan probe emits a non-focused ultrasound beam that results in a one-dimensional representation of echoes returned from ocular structures through which the beam passes. Ocular abnormalitites may be identified and evaluated by assessing the location and amplitude of the spikes produced by various ocular tissues.

The instrument control panel is a touch panel with membrane switch, rotary encoder and foot switch.

The provided text states, "Performance Data: None. The specifications and indications for use of the UD-1000 A/B Scanner are the same or very similar to those of the claimed predicate devices. The UD-1000 has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required."

Therefore, based on the provided input, no acceptance criteria or study demonstrating that the device meets acceptance criteria are described. The manufacturer asserted substantial equivalence to predicate devices, and as such, performance data, including details on acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, were not required.

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