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Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. It is also indicated for the in-office cleaning, rinsing and chemical (not heat) disinfection and storage of trial soft (hydrophilic) lenses for up to thirty (30) days.

Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE™ (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED* (polyaminopropyl biguanide) 0.0001%. The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is also indicated for use in the in-office chemical (not heat) disinfection of trial soft (hydrophilic) contact lenses. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

The provided text describes the regulatory clearance of "BAUSCH & LOMB ReNu MultiPlusTM MULTI-PURPOSE SOLUTION" and its substantial equivalence to a predicate device. It details the product's indications for use and mentions certain preclinical and clinical studies, as well as adherence to specific ISO/CEN and FDA regimen procedures for disinfecting products.

However, the document does not contain the detailed information typically found in acceptance criteria and a study report for a medical device's performance characteristics in the context of an AI/algorithm-driven device. Specifically, it lacks:

• A table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures.
• Information on sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods, MRMC studies, standalone performance details, training set size, or how ground truth for training data was established.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, particularly regarding safety and effectiveness for its intended use as a contact lens solution. The efficacy outlined is related to its biocidal properties against specific microorganisms.

Based on the provided text, here is an attempt to address your request, highlighting what is available and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document refers to adherence to specific standards rather than specific quantitative performance metrics like sensitivity or specificity.

Device Performance Details:

• Biocidal Efficacy: Demonstrated against S. aureus, Ps. aeruginosa, S. marcescens, C. albicans, and F. solani at thirty (30) days, with and without lenses, in glass vials.
• Viral Efficacy: Demonstrated against Herpes simplex Virus, Type 1 and Adenovirus Type 7 at thirty (30) days.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the provided text for the biocidal and viral efficacy tests. The text mentions these tests were performed "in glass vials," implying laboratory-based testing rather than patient data.
• Data Provenance: The efficacy tests were laboratory-based (in vitro), conducted to meet international and FDA draft standards. The country of origin for the underlying data is not specified beyond "preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/ S12." These previous submissions likely contain more detailed provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. The "ground truth" for biocidal efficacy and viral efficacy tests would be determined by laboratory methods and established microbiological standards, not typically by human experts in the way that clinical imaging or diagnostic AI is assessed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not specified. Adjudication methods are typically associated with human expert review of clinical cases. For laboratory efficacy studies, the results are typically quantitative and objective.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This document pertains to a contact lens solution, not an AI or algorithm-driven diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• A standalone performance (algorithmic only) was effectively demonstrated for the solution's biocidal efficacy. The solution itself is the "algorithm" in this context, acting upon microorganisms without human intervention in its primary function. The reference to "ISO Stand Alone Procedure for Disinfecting Products" directly supports this.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The ground truth for the efficacy studies was based on established laboratory testing methods for microbiological and virological reduction/inactivation, as defined by ISO/CEN and FDA draft standards. This is a form of objective, standardized laboratory measurement against known pathogens.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device. The efficacy studies described are validation studies for the chemical solution itself, not for training a model.

9. How the ground truth for the training set was established:

• Not applicable. As noted above, this is not an AI/machine learning device using a training set.

Ask a specific question about this device

Bausch & Lomb ReNu Multi-Purpose Solution is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Bausch & Lomb ReNu Multi-Purpos. Solution is a sterile, isotonic solution that contains HYDRANATE™ (hydroxyalkylphosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED (polyaminopropyl biguanide) 0.0001%. The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

The provided text is a 510(k) summary for the BAUSCH & LOMB ReNu MultiPlus Multi-Purpose Solution. It describes the device, its indications for use, and claims substantial equivalence to predicate devices (Bausch & Lomb ReNu Multi-Purpose Solution and Bausch & Lomb ReNu 1 Step Enzymatic Cleaner).

However, the document does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria, performance metrics, sample sizes, expert qualifications, ground truth establishment, or specific study designs (like MRMC or standalone performance). The 510(k) summary explicitly states:

"A series of preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/ S12. No concerns were raised at the time of approval."

This indicates that the actual study results and detailed methodology are referenced as being in a pre-existing PMA application (P860023/S12) and are not provided within this 510(k) summary. The 510(k) process for this device relies on the previous PMA submission for the establishment of safety and effectiveness, and for demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from the provided text.

To answer your questions, I would need access to the "Premarket Approval Application P860023/ S12" which is referenced in the document.

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