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The LipiView® Ocular Surface Interferometer is intended to image the tear film. The LipiView® Interferometer is a prescription device for use by a physician during an in-office exam.

Indications for Use: 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. Using these images, the LipiView Interferometer measures the absolute thickness of the tear film lipid layer.

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, in a printed report, or captured on video and exported to USBattached storage or a mapped network drive.

The LipiView® Interferometer has been modified to software version 2.0, which includes changes to refine the interferometric color matching and blink detection methods used on interferometric images and to provide minor usability enhancements.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the LipiView® Ocular Surface Interferometer with software version 2.0:

Acceptance Criteria and Device Performance

The provided document details performance testing for hardware changes and software version 2.0. The acceptance criteria are implicitly derived from the successful outcomes of these tests, demonstrating substantial equivalence to the predicate device and validation for the expanded indications.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a series of performance tests rather than a single, unified study with a specific name. The primary focus of the testing was to demonstrate substantial equivalence to the predicate device and to validate the expanded indication for tear film lipid layer thickness measurement.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Description: The document refers to testing with "physical phantoms representative of the pre-corneal tear film of a known thickness." It also mentions "in vivo device measurement variability" testing.
   • Sample Size: The exact sample size for the phantom testing or in vivo variability testing is not specified in the provided text.
   • Data Provenance: The data appears to be prospective as it was generated specifically for the verification and validation of the device with software version 2.0. The country of origin of the data is not specified, but given the applicant and contact person's location in Morrisville, NC, USA, it is highly likely the testing was conducted in the US.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • For the physical phantoms, the ground truth was established by independent ellipsometry measurements, which is an objective physical measurement technique, not by human experts.
   • For aspects like "correctly identified valid blink frames," it is implied that a ground truth was used for comparison, but the number and qualifications of experts involved in establishing this ground truth are not specified.

3. Adjudication Method for the Test Set:

   • Given that the ground truth for lipid layer thickness measurement was established by independent physical methods (ellipsometry) and blink detection likely involved an objective standard for "valid blinks," a human adjudication method like 2+1 or 3+1 is not described and likely not applicable in the traditional sense for these specific tests.

4. 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, an MRMC comparative effectiveness study is not described or implied. This device is an imaging and measurement tool for tear film, not a diagnostic aid that assists human readers in interpreting complex images. The focus is on the device's ability to accurately measure and provide data, rather than on improving human reader performance.

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

   • Yes, standalone performance testing was done. The core "performance testing" described directly assesses the algorithm's ability to measure tear film lipid layer thickness using phantoms and its blink detection capabilities, independent of real-time human interaction. The reported measurement variability and blink detection improvements are measures of the algorithm's standalone performance.

6. The Type of Ground Truth Used:

   • For the lipid layer thickness measurement, the ground truth was objective physical measurement by ellipsometry on physical phantoms of known thickness.
   • For blink detection, the ground truth source is not explicitly stated but would likely be a predefined objective standard for "valid blink frames."

7. The Sample Size for the Training Set:

   • The document does not provide any specific sample size for a training set. It mentions the interferometric color palette was "developed and validated to a known standard," which implies a development process that might involve an internal dataset, but no details are given. The nature of the device (improving an existing physical measurement method) suggests it might not rely on a large, labeled training set in the same way machine learning-based diagnostic algorithms do.

8. How the Ground Truth for the Training Set Was Established:

   • Given that no training set sample size is provided, the method for establishing ground truth for a training set is not described. If "developed to a known standard" refers to an internal process, the ground truth would likely be based on objective physical measurements (similar to the test set ground truth) or carefully defined criteria for blinks.

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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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