(110 days)
The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.
The UBM Plus device is designed as a high frequency ultrasound B-Scan, which uses pulsed echo ultrasound to image the anterior segment of the eye. It utilizes a noncontact probe via a contact Scleral shell to generate and receive the ultrasound pulses, and provides a graphic display of returning pulse echoes to indicate the various structures.
The UBM Plus device's performance data and acceptance criteria are outlined in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated as "acceptable limits") | Reported Device Performance | |
|---|---|---|
| Line |
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.