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Apollo Vue S100 Image System is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.

The ApolloVue S100 Image System consists of a cart-mounted imaging console and robotic arm imagine probe with reusable non-sterile scanning window cap. The light source module, main control board, power supply and personal computer are configured inside the cart. The probe contains interferometer comprise of optics and electronics. The system user interface allows the viewing, capture, review and export of images.

With AMO single-crystal fiber light source, the ApolloVue S100 Image System provides nearinfrared broadband optical output and cellular images with an axial resolution around one micron. The ApolloVue S100 Image System employs full-field OCT (FF-OCT) utilizing a camera for parallel detection to avoid latera scanning and thus increases the scanning speed. The ApolloVue S100 Image System provides both high resolution B-scan and en face imaging with decent scanning speed. The cross-sectional image can be shown in real-time without reconstruction after whole volume is scanned. In addition, by scanning an en-face image plane with the coherence and confocal gates matched, the ApolloVue S100 Image System does not suffer from depth-of-field limitations present in standard OCT and can achieve micron scale transverse image resolutions. With a simple optical switch, user can switch between two modes to improve the efficiency of lesion examination and gather more structure information.

Here's a breakdown of the acceptance criteria and study information for the ApolloVue S100 Image System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of numerical acceptance criteria with corresponding performance metrics from a clinical study for diagnostic accuracy to determine the device's ability to support diagnostic judgments. Instead, it focuses on meeting safety and general performance standards.

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