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The LipiView® II Ocular Surface Interferometer is an ophthalmic imaging device 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. Using these images, LipiView® II measures the absolute thickness of the tear film lipid layer.
• Meibomian glands under near-infrared (NIR) illumination
• The ocular surface and eyelids under white illumination
All of these image types can be photographically documented and visually monitored.

The LipiView® II Ocular Surface Interferometer is a bench-top device used as an ophthalmic camera for imaging the lipid layer of the tear film, meibomian glands, ocular surface and eyelids. There are three imaging modes: Lipid, Gland and Ocular. LipiView II contains a computer system and electronics, two position chin and forehead rest, camera and lens, motion stage, illuminator and touch screen display. LipiView II includes pushbutton controls and handheld near-infrared lid everter for gland imaging.

The provided document is a 510(k) summary for the LipiView II Ocular Surface Interferometer. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria and performance data from a specific clinical study for the device's diagnostic or predictive capabilities.

The document states that "Performance testing demonstrates that the design changes in LipiView II do not raise new questions of safety and effectiveness, and LipiView II is substantially equivalent to the predicate devices." It also mentions usability testing and software validation. However, it does not provide quantitative acceptance criteria or detailed results from a study that "proves the device meets the acceptance criteria" in terms of clinical accuracy (e.g., sensitivity, specificity, agreement with a gold standard).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance in a clinical context.
2. Sample size used for the test set and the data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set.

The document describes the device's technological characteristics, its intended use (imaging the tear film, meibomian glands, ocular surface, and eyelids), and how it compares to predicate devices. It emphasizes safety and effectiveness through compliance with standards (e.g., ISO, ANSI/IEC for light hazard, electrical safety, EMC, material flammability) and through the absence of new safety or effectiveness questions based on design changes.

Summary of what is present in the document regarding "performance testing":

• Usability testing and software validation: These were done to demonstrate that LipiView II is as safe and effective as predicate devices for its intended use.
• Compliance with standards: The device meets standards for light hazard protection (ISO15004-2), electrical safety (ANSI/IEC 60601), electromagnetic compatibility (EMC), and material flammability (UL 94V-1). The use of NIR illumination "does not raise new safety or effectiveness questions."
• Hardware features: New hardware features (two-position chin rest, high-definition camera, NIR illumination, handheld NIR lid everter) "meet all design requirements for safety and performance, and therefore, do not adversely affect safety and effectiveness."

In conclusion, this document primarily asserts that the device's performance, particularly regarding safety and technological characteristics, is substantially equivalent to its predicate devices, rather than providing a detailed report of clinical study acceptance criteria and results for diagnostic performance.

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