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The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.

The Tomophase OCTIS is an imaging tool for the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. The system consists of an Imaging Console and a detachable Probe.

The Imaging Console contains optical and electrical components to utilize NIR light to create high resolution real-time images; and has a user interface for acquiring, displaying, saving and reporting the images.

The Probe is a single-use, sterile device consisting of a sealed sheath and a flexible fiber optic mechanism.

Here's an analysis of the acceptance criteria and the study information based on the provided text for the Tomophase OCTIS 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for a specific clinical task. Instead, the "acceptance criteria" are implied by the successful completion of various safety and bench tests, demonstrating the device's adherence to relevant standards and design objectives.

Therefore, the table below reflects what can be inferred as "acceptance criteria" from the provided document, focusing on safety and technical performance, rather than clinical diagnostic performance.

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

• Sample Size: Not explicitly stated for specific tests beyond the mention of individual test documents (e.g., "Digitizer Qualification," "Optical Connection Tests"). The document refers to "Beth Israel Deaconess Medical Center Report on OCTIS Procedure with Canine TBM Model" for animal testing, implying a sample was used but its size or specific details are not provided.
• Data Provenance:
  • Bench Testing: Performed internally by Tomophase Corporation, as indicated by "Tomophase Documents" for various tests.
  • Animal Testing: Conducted at "Beth Israel Deaconess Medical Center," using a "Canine TBM Model."
  • Retrospective or Prospective: Not specified, but bench and animal testing are typically prospective in nature for performance evaluation. No human clinical data was submitted.

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

• This information is not provided in the document as no human clinical performance data was included in this 510(k) submission. For the animal study, the document does not specify the number or qualifications of experts involved in establishing ground truth.

4. Adjudication Method for the Test Set

• This information is not provided as no human clinical performance data was included. For the animal study, the adjudication method is not mentioned.

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

• No MRMC comparative effectiveness study was mentioned or performed. This device is an imaging tool and the submission explicitly states, "This section is not applicable because Tomophase Corporation is not including any clinical performance data with this 510(k) submission." Therefore, there is no discussion of 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. The Tomophase OCTIS is itself the standalone imaging device. The 510(k) submission describes the hardware and its technical performance characteristics, not an "algorithm only" device that would analyze images from another source. It produces images for a human to interpret.

7. The Type of Ground Truth Used

• For bench testing, the "ground truth" would be the known engineering specifications, calibrated measurements, and adherence to accepted standards.
• For animal testing, while not fully detailed, the ground truth would likely involve histopathology or other diagnostic methods applied to the canine tissue, validated against the OCTIS images. The document does not specify this, however.
• No human pathology or outcomes data was used because no human clinical performance data was included in the submission.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This 510(k) summary describes a physical imaging device, not a machine learning or AI algorithm that requires a training set. The device produces raw images.

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

• Not applicable / Not provided. As mentioned above, there is no indication of a training set for an AI algorithm in this submission.

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