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

Device Description

Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATES (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. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the studies that demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied by studies)	Reported Device Performance
Protein Cleaning Efficacy	Statistical equivalence to predicate device (Alcon OPTI-FREE EXPRESS No Rub) in removing protein deposits from soiled lenses. (No specific quantitative criteria provided).	Both the Test (ReNu MultiPlus) and Control (Alcon OPTI-FREE EXPRESS No Rub) were statistically equivalent in the in-vitro protein cleaning study using soiled Group 1 and 4 lenses and "no rub" regimens.
Microbiological Efficacy	Performance criteria established by FDA for Stand-alone Procedure for Disinfecting Products, Primary Criteria and Regimen Test. (Specific quantitative criteria not provided in this document but implied to be regulatory standards for disinfection).	The results of the Stand-alone Procedure for Disinfecting Products and Regimen Test indicated that the "performance criteria established by FDA have been met." An additional microbiological test with organic soil also "met the requirements of the test." Previous submissions (K974723, K-002823, P860023/S12) also demonstrated efficacy.
Clinical Safety and Efficacy	Demonstration of clinically acceptable lens cleanliness, safety, and efficacy in a clinical setting when used with a 5-second cleaning rinse. Substantial equivalence to the predicate device in terms of safety and efficacy.	A multi-site randomized, controlled clinical study demonstrated "clinically acceptable lens cleanliness" for ReNu MultiPlus. "Safety and efficacy were demonstrated," and the product was found to be "substantially equivalent" to Alcon OPTI-FREE EXPRESS No Rub.
Biocompatibility	No new biocompatibility testing required due to unchanged formulation from previously cleared product. (Implied: previously cleared product met biocompatibility standards).	ReNu MultiPlus Multi-Purpose Solution "remains unchanged from the previously cleared product" and thus "the labeling changes do not require new biocompatibility testing."

2. Sample Size Used for the Test Set and Data Provenance

Protein Cleaning Study: "Groups 1 and 4 lenses artificially soiled with lysozyme." The exact number of lenses or replicates is not specified.
- Provenance: Not explicitly stated, but assumed to be laboratory-based (in-vitro).
Microbiology Studies: Not explicitly stated for the "additional microbiological testing." Reference is made to previous submissions (K974723, K-002823, P860023/S12) for earlier studies.
- Provenance: In-vitro laboratory studies.
Clinical Studies: "A multi-site randomized, controlled clinical study." The exact number of subjects or lenses is not specified.
- Provenance: Prospective clinical study. Country of origin not specified, but likely US-based given the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document for any of the studies. No mention of expert review or reconciliation for ground truth is made.

4. Adjudication Method (for the test set)

This information is not provided in the document. The studies described are either in-vitro technical tests or a clinical trial where clinical outcomes would likely be assessed by investigators and measured against pre-defined criteria, rather than using an adjudication panel in the sense often applied to AI model evaluations.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This device is a contact lens solution, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance in that context. The "clinical study" evaluates the solution's performance on its own, not in conjunction with human interpretation of results.

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

Protein Cleaning Study: Yes, this was an in-vitro standalone test comparing the solution's cleaning efficacy against a control solution. There is no human interpretation component beyond observing the results.
Microbiology Studies: Yes, these were standalone in-vitro tests (Stand-alone Procedure for Disinfecting Products) evaluating the solution's antimicrobial efficacy. There is no human user involvement in the performance evaluation itself.
Clinical Studies: No, the clinical study involved human subjects using the product. While the performance of the solution itself is standalone (it disinfects/cleans on its own), the evaluation of its safety and efficacy is within a human-in-the-loop setting (patients using the product and being monitored). However, it's not a "standalone algorithm" in the typical sense of AI evaluation.

7. The Type of Ground Truth Used

Protein Cleaning Study: The "ground truth" was established by artificially soiling lenses with lysozyme and then quantitatively or qualitatively assessing protein removal.
Microbiology Studies: The "ground truth" was established by using standardized microbial challenges (specific types and concentrations of microorganisms) and measuring log reductions or kill rates according to established FDA-recognized test procedures.
Clinical Studies: The "ground truth" for clinical safety and efficacy would have been based on clinical endpoints and observations (e.g., visual acuity, comfort, adverse events, lens deposition levels as assessed by ophthalmologists/optometrists) and objective measures of lens cleanliness.

8. The Sample Size for the Training Set

This information is not applicable as this is a contact lens solution and not an AI/machine learning device that requires a "training set." The studies performed are traditional chemistry, microbiology, and clinical performance evaluations.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

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