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The Ophthalmic Technologies i-Scope™ is intended to be used for visualization of intra-ocular structures, as a means to introduce micro instruments into the eye, or as a means to introduce laser fibers into the eye for photocoagulation.

The Ophthalmic Technologies i-Scope™ is a rigid ophthalmic fiber-optic microendoscope. The i-Scope has an imaging fiber bundle with 10,000 pixels, an illumination fiber, and a working channel for an optional laser fiber or microinstruments. The laser fiber is disposable and can be replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.

The K971679 510(k) submission for the Ophthalmic Technologies i-scope does not contain a study that establishes acceptance criteria for its device performance in the way a diagnostic AI device would. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and material comparisons, as clinical tests were not required. The device is an ophthalmic endoscope, not an AI-based diagnostic tool.

Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document.

Here's an attempt to address the request with the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission does not describe a clinical test set with human or patient data for evaluating performance against predefined acceptance criteria. The "tests" mentioned are non-clinical, likely involving physical measurements or comparisons.

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

• Not Applicable. Ground truth, in the context of diagnostic performance, is not established or reported in this submission for the evaluation of the device.

4. Adjudication method for the test set

• Not Applicable. No test set requiring adjudication in the context of diagnostic performance is described.

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

• No, a MRMC comparative effectiveness study was not done. This device is an ophthalmic endoscope, not an AI diagnostic tool, so such a study would not be relevant.

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

• Not Applicable. The OTI i-scope is a physical medical device (endoscope), not an algorithm. Standalone algorithm performance is irrelevant.

7. The type of ground truth used

• Not Applicable. For the non-clinical tests (resolution, light output), the "ground truth" would be the known physical properties or established measurement standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not Applicable. This device is not an AI algorithm that requires a training set.

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

• Not Applicable. This device is not an AI algorithm and therefore has no training set or associated ground truth.

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