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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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The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

The LipiView® Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.

The provided 510(k) summary for the LipiView® Ocular Surface Interferometer (K091935) does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in terms of clinical performance or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and compliance with relevant safety and manufacturing standards.

Here's an analysis based on the provided text, highlighting the absence of information where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not include a table of specific acceptance criteria related to a clinical performance study (e.g., sensitivity, specificity, accuracy for a particular clinical task) nor does it report such performance metrics. The "performance testing" mentioned refers to compliance with safety and manufacturing standards.

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

No specific test set or clinical study data is provided in the document from which to derive a sample size or data provenance. The submission focuses on device design and comparison to predicate devices, not a clinical performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Since no clinical performance study or test set data is provided, there is no mention of experts establishing ground truth for such a study.

4. Adjudication Method

Not applicable. Since no clinical performance study or test set data is provided, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technological characteristics and safety standards, rather than a clinical trial comparing device performance with and without AI assistance or against human readers.

6. Standalone Performance Study (Algorithm Only)

The device described is an "Ocular Surface Interferometer," an imaging device. While it contains computer software, the provided summary does not detail any standalone algorithmic performance (e.g., automated disease detection, quantification of a specific biological marker) that would necessitate a standalone performance study in the way modern AI/ML devices often do. Its intended use is to capture, archive, manipulate, and store digital images for visual monitoring and documentation by a physician.

7. Type of Ground Truth Used

Not applicable. As no clinical performance study is detailed, no specific ground truth (expert consensus, pathology, outcomes data) is discussed for such a study.

8. Sample Size for the Training Set

Not applicable. The document does not describe the development of an AI/ML algorithm that would require a training set in the conventional sense. The "software was developed and tested in compliance with FDA Guidance documents for software validation in medical devices," which refers to general software engineering principles, not necessarily AI model training.

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

Not applicable. As no AI/ML algorithm requiring a training set is described, no ground truth establishment method for a training set is mentioned.

Conclusion based on the provided document:

The 510(k) submission for the LipiView® Ocular Surface Interferometer (K091935) relied primarily on demonstrating substantial equivalence to already cleared predicate devices by comparing their intended use, technological characteristics, and compliance with applicable safety and manufacturing standards. It does not present detailed clinical acceptance criteria or a study focused on clinical performance metrics like diagnostic accuracy, sensitivity, or specificity for a particular clinical condition. The "performance testing" cited pertains to engineering and safety standards, not clinical effectiveness.

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