Search Results

The OTIS 2.0 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

The Perimeter OTIS™ 2.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.0 is based on optical coherence tomography (OCT) imaging, and it uses non-ionizing, low-power optical radiation to produce high resolution, sub-surface images of a tissue sample. Due to the extremely high velocity of light, optical echoes (reflected and backscattered light from the sample) cannot be measured directly using a photodetector. Instead, OCT devices use an interferometer to compare a reference beam of light to the backscattered light returning from the tissue sample. The features in an OCT image are created by changes in the optical properties (namely scattering, absorption, and index of refraction) of the sample.

The Perimeter OTIS™ 2.0 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the predicate Perimeter OTIS 1B System (K171560). Like its predicate, the Perimeter OTIS™ 2.0 has automated the OCT scanning of the specimen surface, standardizing the image collection process.

The Perimeter OTIS™ 2.0 includes a white light image (photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the photograph and the OCT image scan position. The Perimeter OTIS™ 2.0 also includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.

The Perimeter OTIS™ 2.0 Optical Coherence Tomography System is compared to its predicate device, the Perimeter OTIS™ 1B. The provided text, however, does not directly state specific acceptance criteria (e.g., numerical performance metrics like sensitivity, specificity, accuracy) for the device's ability to identify tissue microstructure features, nor details of a study with such specific performance metrics. Instead, it focuses on demonstrating substantial equivalence in terms of technology, intended use, and image quality compared to the predicate device.

Here's a breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results in terms of identifying tissue microstructure features. It primarily emphasizes that the OTIS™ 2.0 can obtain OCT images with sufficient image quality to identify excised tissue microstructure features, at a level comparable to other OCT imaging systems, including the predicate device, OTIS 1B.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Perimeter validated that the OTIS™ 2.0 can obtain OCT images with sufficient image quality to identify excised tissue microstructure features, at a level comparable to other OCT imaging systems, including the predicate device, OTIS 1B."

However, it does not specify the sample size for the test set used in this validation, nor does it mention the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth for image quality or feature identification, nor does it detail their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study and therefore does not report any effect size of human readers improving with or without AI assistance. The device description focuses on its imaging capabilities and user interface for review and annotation, not on direct assistance to human interpretation in a comparative effectiveness study.

6. Standalone (Algorithm-only) Performance Study

The document describes the device as an "imaging tool in the evaluation of excised human tissue microstructure" with "image review manipulation software for identifying and annotating regions of interest." This implies a human-in-the-loop system. The text does not describe a standalone (algorithm-only) performance study for automated identification or diagnosis without human input.

7. Type of Ground Truth Used

The ground truth used for validation was "sufficient image quality to identify excised tissue microstructure features." This suggests an assessment of the visual clarity and detail in the images, allowing for the potential identification of microstructural features. However, the exact nature of this "ground truth" (e.g., expert consensus on image quality, comparison to histological slides, etc.) is not explicitly detailed.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. The validation described focuses on the device's ability to produce images of "sufficient image quality" comparable to existing OCT systems, rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.

Ask a specific question about this device