OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

The Perimeter OTIS™ 2.1 system is an imaging tool utilizing optical coherence tomography to provide real-time, high-resolution, cross-sectional subsurface visualization of excised human tissue microstructure. It operates by detecting changes in tissue optical properties via an interferometric comparison of reference and backscattered light, enabling standardized image acquisition, review, and annotation for detailed tissue evaluation.

The Perimeter OTIS™ 2.1 is an optical coherence tomography (OCT) system designed as an imaging tool for the ex vivo evaluation of human tissue microstructure. Its methodology is based on OCT, which, similar to ultrasound, generates images but utilizes non-ionizing, low-power optical radiation. The system employs an interferometer to compare a reference light beam with light backscattered from the tissue sample. Image contrast is derived from variations in the tissue's optical properties, such as scattering, absorption, and index of refraction, allowing for high-resolution, sub-surface visualization. The OTIS™ 2.1 automates the OCT scanning process across the specimen surface, standardizing image collection. The device provides two-dimensional, cross-sectional, real-time depth visualization and includes image review manipulation software for identifying and annotating regions of interest. It allows for concurrent image review and acquisition. Key imaging specifications include a center wavelength of 1325 ± 15 μm, lateral resolution of 20 μm, and axial resolution of 10–15 μm in tissue, with a scan acquisition time of less than one minute for a 5x5 cm area. The OTIS™ 2.1 represents an updated version of the OTIS 2.0, featuring a smaller cart footprint, a faster PC, design improvements for manufacturability, component updates, optimized image acquisition and processing, and an improved graphical user interface. These enhancements do not alter the fundamental scientific technology or intended use, and performance testing confirmed its capabilities for evaluating excised tissue.

AI Regulatory Concerns

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• Q1. How does the 10-15 μm axial resolution of the OTIS™ 2.1 system correlate with the detection limits for specific microstructural features relevant to pathological assessment in different tissue types (e.g., breast, skin, prostate)?; What is the maximum imaging depth achievable by the OTIS™ 2.1 in various types of excised human tissue, and how does tissue density or composition affect this depth and image quality?; Can the image annotation and manipulation software be integrated with existing digital pathology workflows or AI-driven diagnostic tools to enhance or expedite tissue analysis?; Beyond identifying regions of interest, what quantitative metrics, if any, can be derived from the OTIS™ 2.1 images (e.g., tissue scattering coefficients, layer thickness) that might provide objective measures for tissue characterization?; How does the "concurrent image review and acquisition" feature impact the workflow efficiency in a clinical or research setting, particularly during procedures like intraoperative margin assessment?