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510(k) Data Aggregation
(186 days)
Bausch and Lomb Incorporated
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(50 days)
Bausch and Lomb Incorporated
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.
Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).
The provided document is a 510(k) premarket notification for Bausch + Lomb Boston ADVANCE Cleaner and Conditioning Solution. It is not a document describing a medical imaging AI device or a study involving human readers and AI assistance.
Therefore, none of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance can be extracted from this document.
This document primarily focuses on demonstrating substantial equivalence of a modified contact lens care regimen (replacing water rinse with saline solution) to a previously cleared regimen, based on microbiology and lens compatibility testing, and re-using previously established biocompatibility and clinical data.
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(86 days)
Bausch and Lomb, Inc.
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.
This document describes the premarket notification for the "Easy-Load Lens Delivery System" (Model EZ-24). It's an intraocular lens guide used for folding and injecting intraocular lenses.
Here's the information regarding the acceptance criteria and study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | TEST | Acceptance Criteria | RESULTS |
|---|---|---|---|
| Function Performance | (Before and after insertion) IOL surface & bulk homogeneity | Free from surface and bulk defects and all edges should appear smooth when viewed at 10X magnification | Pass |
| (Before and after insertion) IOL lens power | The diopter power of the lenses shall be within the allowed tolerance | Pass | |
| (Before and after insertion) IOL image quality | The image quality of the lenses shall meet or exceed the minimum resolution group element of the Air Force target specified in the protocol. | Pass | |
| (Before and after insertion) IOL dimensions | The lenses must meet the dimensional requirements specified in the protocol. | Pass | |
| IOL delivery outcome | The IOLs do not flip over upon delivery; The IOL must exit inserter upon completion of delivery; No cosmetic defects to the IOL's haptic from folding and/or delivery | Pass | |
| Damage to insertion device | No damage to the insertion device due to lens delivery | Pass | |
| Lubricant transfer study | No detectable transfer | Pass | |
| Particle study | Comparable to or lower than control | Pass | |
| Sterilization verification | Comparative Resistance Performance Determination | For a given exposure time the average recovery of viable test organisms from biological indicators placed within the barrel of either the EZ-24 or the EZ-28 shall differ by no more than one logarithm of the average of the values determined for both inserters. Alternatively, the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-24 may be less than the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-28 inserters | Pass |
| EO transfer test | $\le$ 0.5μg EO per IOL | Pass | |
| Endotoxin test | $ |
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