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The OTIS 2.1 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™ 2.1 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.1 is based on optical coherence tomography (OCT) imaging, which is similar to ultrasound, but 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™ 2.1 collects and displays OCT images of human tissue with comparable image quality to the predicate Perimeter OTIS 2.0 System (K190404). Like its predicate, the Perimeter OTIS™ 2.1 has automated the OCT scanning of the specimen surface, standardizing the image collection process and facilitating image manipulation for review and annotation. OTIS 2.1 allows for the concurrent image review and acquisition.

The provided text does not contain detailed acceptance criteria, device performance data beyond general statements, nor a specific study demonstrating how the device meets such criteria. It primarily focuses on the device's substantial equivalence to a predicate device (Perimeter OTIS™ 2.0, K190404) based on similar intended use, indications for use, principles of operation, and technological characteristics.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available. The document states that "verification studies demonstrated that outputs met design input requirements, and that validation studies demonstrated that the Perimeter OTIS™ 2.1 fulfilled the intended use and met user needs." However, specific quantitative acceptance criteria or detailed performance metrics are not provided. The table of characteristics (on page 5) compares the subject device (OTIS 2.1) to the predicate (OTIS 2.0) and states "Same" for all listed technical specifications, implying the performance is expected to be identical to the predicate, but it doesn't present acceptance criteria or reported performance outcomes against those criteria.

2. Sample size used for the test set and the data provenance:

• Not available. The document mentions "verification and validation activities" and "design verification and validation testing," but does not provide information on the sample size of any test sets (e.g., number of tissue samples tested). Data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not available. The document describes the device as an "imaging tool in the evaluation of excised human tissue microstructure." It does not mention any expert review or ground truthing process in the context of a clinical study or performance evaluation with human readers. The focus is on technical verification and validation against design inputs and the predicate device's performance.

4. Adjudication method for the test set:

• Not applicable/Not available. No information about adjudication methods for a test set is provided, as there's no mention of expert evaluation of device outputs.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not available. The device, OTIS 2.1, is described as an "imaging tool" for "evaluation of excised human tissue microstructure." There is no indication that it includes AI or that an MRMC study was conducted to evaluate human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not available. The device is an imaging system. The context of "standalone algorithm performance" typically applies to AI/ML software devices. While the system has "image review manipulation software," the document does not discuss any standalone algorithm performance or AI features.

7. The type of ground truth used:

• Not available/Implicitly technical specifications. Given that the document mainly focuses on showing equivalence to a predicate and meeting design inputs through "verification and validation activities," the "ground truth" implicitly refers to the device's technical specifications and the expected image quality for human evaluation, rather than a clinical ground truth like pathology or outcomes data for automated diagnosis or detection. The document specifies objective characteristics like "Lateral Resolution" and "Axial Resolution" as being the "Same" as the predicate.

8. The sample size for the training set:

• Not applicable/Not available. This device is an imaging system, not explicitly described as an AI/ML device that would require a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable/Not available. As above, a "training set" and its ground truth are not relevant to the information provided about this device.

In summary, the provided FDA document is a 510(k) summary for a "Special 510(k) Submission" seeking clearance for an updated version of an already cleared device (OTIS 2.0). The primary claim is substantial equivalence due to minor changes that do not affect the fundamental scientific technology or intended use. This type of submission relies heavily on demonstrating that the updated device performs identically to the predicate in its core functions and meets established safety and performance standards for imaging systems, rather than presenting new clinical study data with specific acceptance criteria and detailed performance metrics against a defined ground truth.

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