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Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone 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 One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.

The provided text describes a 510(k) premarket notification for a contact lens care product, the "Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner." The submission seeks to add an alternative manufacturing site and change packaging resin and raw material suppliers.

However, the document does not contain information about acceptance criteria for a device's performance based on AI/algorithm/software output, nor does it detail a study proving the device meets such criteria. The "Preclinical testing" mentioned is related to biocompatibility and confirms the safety and effectiveness of the product itself, not a software device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information (specifically points 1-9 regarding an AI/algorithm-based device and its validation) is absent from the provided text.

The text focuses on the following:

• Device Type: A contact lens care solution (not an AI/software device).
• Purpose of 510(k) Submission: To add an alternative manufacturing site and modify packaging components, not to introduce or validate a new AI/software feature or performance.
• Testing Mentioned: Biocompatibility, cytotoxicity, and ocular irritation studies related to the chemical solution and its packaging components. These are standard tests for medical devices that come into contact with human tissue, not for evaluating AI performance metrics like sensitivity, specificity, or reader improvement.

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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.

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