(51 days)
Bausch + Lomb Boston Simplus Multi-Action Solution is indicated for cleaning protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate rigid gas permeable contact lenses.
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
Bausch + Lomb Boston Simplus Multi-Action Solution is a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalkylphosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%).
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.
This document, a 510(k) K181627 for Bausch + Lomb Boston SIMPLUS Multi-Action Solution and Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner, does not provide information about a study that proves the device meets specific acceptance criteria using a test set, expert ground truth, or MRMC studies.
The submission is for an update to labeling regarding the use of water with the products, not a re-evaluation of the product's fundamental performance against new or existing criteria. It explicitly states: "The only change proposed in this 510(k) is related to removing water from the lens case regimen, and enhancing the warnings related to the use of water. ...The modification to remove water from the lens case rinse in addition to adding warnings related to the use of water do not have an impact on the safety or efficacy of the product and the products remain substantially equivalent to the current commercialized product as there is no change in formulation or regimen."
Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory compliance with labeling guidance and demonstrating substantial equivalence based on the lack of change in formulation or primary care regimen, rather than presenting performance data from a specific study with defined acceptance criteria and test sets.
To reiterate, the provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes used for a test set or data provenance.
- Information on experts used for ground truth or adjudication methods.
- Any mention of MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Details on the type of ground truth used (e.g., pathology, outcomes).
- Sample size for a training set or how its ground truth was established.
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”