Search Results

The Vibrant Vue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The VibrantVue Scleral Saline is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. The VibrantVue Scleral Saline is a 0.9 % saline solution that conforms to the requirements of USP saline. The rinsing solution removes loose debris and lens cleaners off rigid gas permeable (RGP) contact lenses following proper disinfection as recommended by the eye care practitioner. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the VibrantVue Scleral Saline:

This document describes a medical device, VibrantVue Scleral Saline, and its clearance through the FDA's 510(k) pathway. The 510(k) process is for devices found to be "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. As such, the "acceptance criteria" discussed below relate to demonstrating substantial equivalence and meeting established standards for saline solutions and contact lens care products.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" with numerical performance metrics in the way one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to the predicate device and meeting recognized standards for saline solutions and contact lens care products.

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

The document states that only non-clinical studies were conducted. There was no "test set" in the context of human patient data for the VibrantVue Scleral Saline device.

The non-clinical studies would have involved laboratory testing of the saline solution itself, its packaging, and its interaction with contact lens materials. The data provenance for these non-clinical studies is not specified (e.g., in-house lab, third-party lab), nor are specific sample sizes for these tests detailed in this summary.

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

Not applicable. No clinical test set involving human data was used, therefore no experts were required to establish ground truth for such a set. The "ground truth" for the non-clinical tests would be defined by established scientific methods, standards (e.g., USP monograph for 0.9% saline), and regulatory requirements for sterility, compatibility, and toxicity.

4. Adjudication Method for the Test Set

Not applicable. As there was no clinical test set requiring human interpretation, no adjudication method was used. Non-clinical studies rely on standardized test protocols and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to assess human reader performance, often with and without AI assistance, for diagnostic or interpretive tasks. The VibrantVue Scleral Saline is a contact lens care solution, not a diagnostic or AI-powered device, so such a study is not relevant or required for its clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The VibrantVue Scleral Saline is a physical medical device (a saline solution), not an algorithm or AI system. Therefore, "standalone (algorithm only)" performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical studies, the "ground truth" was established based on:

• USP Monograph for 0.9% Saline: This defines the chemical composition and purity standards for saline.
• Industry Standards and Regulatory Requirements: For sterility, packaging safety (non-toxicity, non-irritating), and physical compatibility with RGP contact lenses. These are typically objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. As VibrantVue Scleral Saline is a physical medical device and not an AI/ML algorithm, there was no "training set."

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

Not applicable. There was no training set.

Ask a specific question about this device

Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.

Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

This document describes the premarket notification (510(k)) for the Bausch + Lomb Sensitive Eyes Plus Saline Solution, which is a sterile, preserved solution for rinsing contact lenses. The study mainly focuses on demonstrating substantial equivalence to predicate devices and expanding its indications for use to include gas permeable contact lenses.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance metrics for a diagnostic device. Instead, it refers to standards and general requirements for contact lens care products. The "acceptance criteria" are implied by adherence to these standards and the demonstration of safety and effectiveness.

Here's a summary of the performance claims based on the described studies:

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

• The document does not specify the sample sizes used for the microbiology, biocompatibility, or lens compatibility test sets.
• Data provenance: The studies were performed by or sponsored by Bausch + Lomb. The specific country of origin for the data is not mentioned but appears to be part of a submission to the U.S. FDA, indicating the data would be accepted under U.S. regulatory standards. These are preclinical (laboratory) studies, not typically categorized as retrospective or prospective in the same way clinical trials are.

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

• This information is not provided in the document. The studies are primarily laboratory-based (microbiology, lens compatibility) and a declaration of no new biocompatibility testing needed due to prior clearance. Expert consensus for "ground truth" as typically understood in diagnostic device evaluations is not applicable here.

4. Adjudication method for the test set

• This information is not provided and is not applicable for the type of laboratory and preclinical studies presented. Adjudication methods are typically used in clinical studies involving human observers or subjective assessments.

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, an MRMC comparative effectiveness study was not done. This device is a saline solution and not an AI-powered diagnostic device. Therefore, a study involving human readers and AI assistance is not relevant or described.

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

• No, a standalone algorithm performance study was not done. This device is a physical product (saline solution), not an algorithm or AI.

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

• For the microbiology studies, the "ground truth" would be defined by the established laboratory methods and criteria in ISO 14730 and the FDA Guidance document. This involves direct measurement of antimicrobial efficacy against specified microorganisms.
• For lens compatibility, the "ground truth" is defined by the objective standards and methods outlined in ISO 11981, which assess physical characteristics of lenses after exposure to the solution.
• For biocompatibility, the "ground truth" was established by previous testing and regulatory clearance of the device/components, meaning it met established safety standards.
• The absence of clinical studies for this submission means no direct "outcomes data" or "pathology" was generated for new approval, relying instead on historical data and preclinical testing.

8. The sample size for the training set

• This is not applicable as this submission is for a medical device (saline solution), not an AI/machine learning model that requires a "training set."

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

• This is not applicable for the same reason as point 8.

Ask a specific question about this device