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BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or notaphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.

Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eye care professional. The lens may be disinfected using a chemical disinfection system.

The PureVision Multi-Focal Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The lens material is the same silicone-hydrogel material as the visibility tinted balafilcon A contact lens described in K972454 and P980006. The color additive conforms with 21 CFR Part 73.3106.

I am sorry, but the provided text is a 510(k) Premarket Notification for a contact lens, not a description of a study with acceptance criteria for a device's performance that would typically involve AI/ML.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, and indications for use, rather than presenting a performance study with specific acceptance criteria that your questions imply for AI/driven devices.

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