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.

Device Description

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.

AI/ML Overview

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.

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.
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.
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.
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.
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.
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."
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.
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.

Summary

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510 (k): K122481

DEC 3 1 2012

510(k) SUMMARY

PREPARATION DATE:	December 12, 2012
APPLICANT:	TearScience, Inc.5151 McCrimmon Parkway, Suite 250Morrisville, NC 27560Tel: (919) 459-4815Fax: (877) 468-5335
CONTACT PERSON:	Christy Stevens, OD, MPHVice President, Clinical & Regulatory
DEVICE TRADE NAME:	LipiView® Ocular Surface Interferometer
COMMON NAME:	Ophthalmic Imaging Device
CLASSIFICATION NAME:	Ophthalmic Camera
DEVICE CLASSIFICATION:	Class II, 21 CFR 886.1120 and 886.1850
PRODUCT CODE:	HKI, HJO
PREDICATE DEVICE:	LipiView® Ocular Surface InterferometerClass II under 21 CFR 886.1120 and 21 CFR 886.1850Product Code HKI, HJO; Applicant: TearScience, Inc.;Cleared under K091935 on October 23, 2009

DEVICE DESCRIPTION:

INTENDED USE:

The LipiView® 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.

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The LipiView® Interferometer with software version 2.0 has the same intended use as the predicate LipiView® Interferometer (K091935). In addition, the Indications for Use are similar to the predicate device, except that the Indications for Use have been expanded for the LipiView® Interferometer with software version 2.0 to include measurement of the tear film lipid laver thickness, as supported by performance testing. The expanded Indications for Use do not alter the intended use of the LipiView® Interferometer.

TECHNOLOGICAL CHARACTERISTICS:

The LipiView® Interferometer with software version 2.0 has the same fundamental scientific technology as the predicate device. As summarized below, most of the technological characteristics of the LipiView® Interferometer with the modification to software version 2.0 remain unchanged from the predicate device cleared under K091935. Minor differences in technology between the predicate device and the LipiView® Interferometer with software version 2.0 are described below.

Similarities: The LipiView® Interferometer with software version 2.0 and the predicate device share many of the same design features. Both devices have the same operating principle of real-time imaging of tear film dynamics based on the interference pattern from specular reflections. Both devices have an AC power source in compliance with IEC 60601 standards for electrical safety and electromagnetic compatibility. Both devices use the same Class I white light LED illuminator with exposure and level of illumination in compliance with ISO 15004-2 (Group 1 instrument) for safety. The patient contact materials for the chin and forehead rest and the method of disinfection are the same for both devices. Also, both devices have a digital video camera, personal computer with Microsoft Windows-based operating system, touchscreen display graphical user interface and computer accessory support for printing and data storage.

Furthermore, analogous software features on both devices include: password-protected user login; patient database; real-time video display to acquire tear film images; touchscreen user controls for camera and video playback; image acquisition process with storage of lossless A VI format video images; and tear film video playback and analysis.

Differences: Compared to the predicate device, the LipiView® Interferometer with software version 2.0 has refined interferometric color matching and blink detection methods used on interferometric images. In the predicate device, the interferometric color palette was theoretically derived: whereas in software version 2.0. the palette was developed and validated to a known standard for measurement of the tear film lipid layer thickness. Software version 2.0 also has enhancements for user convenience including: playback blink visualization; automated documentation of blinks; example tear film videos; adjustable video capture length; and ability to export video to an external USB storage device or mapped network drive.

PERFORMANCE TESTING:

The LipiView® Interferometer with software version 2.0 was developed and tested in compliance with design controls and the FDA Guidance documents for software validation in medical devices. To support the expanded Indications for Use, the LipiView® Interferometer was validated to physical phantoms representative of the pre-corneal tear film of a known thickness, as measured independently by ellipsometry. This testing demonstrated the

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LipiView® Interferometer can make absolute measurements of the tear film lipid layer thickness by imaging interferometric colors. Test results showed the in vivo device measurement variability is 0.31 interferometric color unit (ICU) on average, or slightly less than one-third of the reporting precision of the device (1 ICU). 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. Tests also showed that version 2.0 had a higher overall percentage of correctly identified valid blink frames as compared to the predicate device. Enhancements for user convenience in software version 2.0 performed as intended and did not introduce any new risks to the device.

CONCLUSIONS:

The LipiView Ocular Surface Interferometer with software version 2.0 has the same intended use and the same fundamental scientific technology as the predicate device. Performance testing demonstrates the LipiView® Interferometer with software version 2.0 is substantially equivalent in technological characteristics to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 3 1 2012

Tearscience, Inc. c/o Christy Stevens, OD VP. Clinical & Regulatory Affairs 5151 McCrimmon Parkway, Suite 250 Morrisville, NC 27560

Re: K122481

Trade/Device Name: LipiView Ocular Surface Interferometer Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI, HJO Dated: December 18, 2012 Received: December 19, 2012

Dear Dr. Stevens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Dr. Christy Stevens

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Deborah L. Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number:

KIZL 48 | 8 | To Be Assigned By FDA)

Device Name: LipiView® Ocular Surface Interferometer with Software Version 2.0

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.

Prescription Use X · (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number

Page of

Page 40 of 1022

Regulation Number and Section

§ 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.