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The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

OIS EyeScan is a portable, modular imaging device, which is designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit). OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review and analysis. The device comprises a base unit, and interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.

The provided text describes the OIS EyeScan Portable Modular Imaging System, a portable monocular camera intended for imaging both the posterior and anterior segments of the eye. It is suitable for documenting findings in a clinical setting.

However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than proving a new device's efficacy through specific clinical performance studies with acceptance criteria, sample sizes, and ground truth methodologies.

Therefore, the requested information cannot be fully extracted as such studies are not present in this 510(k) submission.

Here's an breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for disease detection or diagnostic accuracy. The acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This means the device should have similar technological characteristics, intended use, and be as safe and effective as existing legally marketed devices.
• Reported Device Performance: The document only states that the device was subjected to "extensive performance testing and validation" and that "EMC and safety tests currently underway will ensure the device complies with industry and safety standards." No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for clinical tasks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. This submission focuses on demonstrating substantial equivalence, not on a clinical performance study with a test set of patient data to assess diagnostic accuracy. Therefore, sample sizes and data provenance for such a test set are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. As there is no clinical performance study with a "test set" of patient data to establish ground truth on, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical performance study requiring adjudication 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:

• Not applicable. This document describes a new imaging system, not an AI-powered diagnostic aide designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

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

• Not applicable. This device is an imaging system, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable. As a clinical performance study for diagnostic accuracy is not outlined, the concept of "ground truth" for disease states is not relevant in this 510(k) summary. The "ground truth" for this submission would be adherence to functional specifications, safety standards, and equivalence to predicate devices.

8. The sample size for the training set:

• Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set of data.

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

• Not applicable. As there is no training set mentioned, this information is irrelevant.

Summary of Device Evaluation in the 510(k) Submission:

The OIS EyeScan Portable Modular Imaging System demonstrated substantial equivalence by:

• Comparative Analysis to Predicate Devices: The submission extensively compares the OIS EyeScan to several predicate devices (Topcon TRC-50EX and TRC-50IX, WinStation Digital Imaging System, IRI Integrated Retinal Imager, BX900, Tearscope Plus).
• Similarities Highlighted: The document emphasizes that the OIS EyeScan employs similar principles (light photography), light sources (LEDs instead of halogen/xenon lamps), optical specifications, image processing, and storage capabilities as the predicate devices.
• Performance Testing: While specific results are not provided, the document states the device underwent "extensive performance testing and validation" and "software validation tests" to ensure it met "all its functional specifications." This functional specification fulfillment is the closest equivalent to "acceptance criteria" in this context.
• Safety and EMC Compliance: The submission notes that EMC and safety tests were underway or completed to ensure compliance with industry and safety standards, another critical aspect of demonstrating equivalence.

Conclusion Drawn:

The conclusion drawn from the performance testing (functional and safety) and the comparison to predicate devices is that the OIS EyeScan Portable Modular Imaging System is substantially equivalent in safety and effectiveness to the listed predicate devices. This substantial equivalence is the primary "proof" provided in a 510(k) process for devices of this nature, rather than a clinical trial demonstrating specific diagnostic performance metrics against a defined ground truth.

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