(139 days)
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
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (LipiView® Interferometer with Software v2.0) |
|---|---|---|
| Tear Film Lipid Layer Thickness Measurement | Ability to make absolute measurements of the tear film lipid layer thickness by imaging interferometric colors. | |
| Validation of the interferometric color palette to a known standard for measurement of tear film lipid layer thickness. | Demonstrated ability to make absolute measurements of the tear film lipid layer thickness by imaging interferometric colors, validated through physical phantoms representative of the pre-corneal tear film of known thickness (measured independently by ellipsometry). The color palette was developed and validated to a known standard for measurement of the tear film lipid layer thickness. | |
| Device Measurement Variability (Reproducibility/Precision) | In vivo device measurement variability must be within acceptable limits (implicitly, a low variability). | In vivo device measurement variability was 0.31 interferometric color unit (ICU) on average, which is described as "slightly less than one-third of the reporting precision of the device (1 ICU)." This indicates good precision. |
| Interferometric Color Matching Performance | Performance should be equal to or better than the predicate device. | Verification and validation test results demonstrated that the interferometric color matching performance of the LipiView® Interferometer with software version 2.0 is equal to or better than the predicate device. |
| Blink Detection Accuracy | Improved or maintained accuracy of correctly identified valid blink frames compared to the predicate device. | Tests showed that version 2.0 had a higher overall percentage of correctly identified valid blink frames as compared to the predicate device. |
| User Convenience Enhancements | Enhancements should perform as intended and not introduce any new risks. | Enhancements for user convenience (playback blink visualization, automated documentation of blinks, example tear film videos, adjustable video capture length, export video) performed as intended and did not introduce any new risks to the device. |
| Software Validation & Design Controls | Compliance with FDA Guidance for software validation and design controls. | The device was developed and tested in compliance with design controls and the FDA Guidance documents for software validation in medical devices. |
| Safety (Electrical, EMC, Light) | Compliance with relevant safety standards (IEC 60601, ISO 15004-2). | Same operating principle as predicate, AC power source in compliance with IEC 60601 (electrical safety and EMC), Class I white light LED illuminator with exposure and level of illumination in compliance with ISO 15004-2 (Group 1 instrument) for safety. Patient contact materials and disinfection methods are the same as the predicate. |
| Fundamental Scientific Technology | Must be the same as the predicate device. | The LipiView® Interferometer with software version 2.0 has the same fundamental scientific technology as the predicate device (real-time imaging of tear film dynamics based on interference pattern from specular reflections). |
| Intended Use Equivalence | Same intended use as the predicate device; expanded indications for use must not alter the intended use. | The device has the same intended use as the predicate. The expanded Indications for Use (measurement of tear film lipid layer thickness) do not alter the intended use of the LipiView® Interferometer. |
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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.
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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.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.