(170 days)
Bausch & Lomb Multi-Purpose Solution NRC03 is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranate® (hydroxyalkylphosphonate), poloxamer 407, polyquaternium-10, poloxamine 1107, purified water and preserved with 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 with a tamper evident seal and is labeled with a lot number and expiration date.
Here's a breakdown of the acceptance criteria and study information for the Bausch & Lomb Multi-Purpose Solution NRC03, based on the provided text:
Important Note: This document is a 510(k) summary, which often provides high-level information. Therefore, specific details like exact sample sizes for all studies, ground truth methodologies for certain tests, and expert qualifications are not fully elaborated in this summary.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes a series of studies designed to demonstrate effectiveness and safety, and then concludes with a statement of "satisfactory levels" or "statistical significance/equivalence." The primary "acceptance criteria" here are implied to be the achievement of safety and efficacy levels comparable to existing predicate devices, as well as adherence to FDA Guidance for disinfection.
Here's an attempt to structure the information based on the provided text, recognizing the limitations of the summary format:
| Study/Criterion Category | Implied Acceptance Criteria (Goal) | Reported Device Performance |
|---|---|---|
| Toxicology | No evidence of cytotoxicity or eye irritation with the solution or lenses cycled in it. | "there was no evidence of toxicity." |
| Lens Compatibility | Lenses should remain compatible with the solution after cycling. | "The results indicated that lenses were compatible with the solution." |
| Microbiology | Satisfactory levels of disinfection efficacy (per FDA Guidance documents and modifications to established procedures). | "The results indicate satisfactory levels of disinfection efficacy." |
| Cleaning Efficacy | Prevention of Protein Deposition: Significant prevention of protein deposition during a no-rub with rinse regimen and 4-hour disinfection. | "Protein deposition was significantly prevented as measured by Image Analysis." |
| Removal of Protein Deposits: Statistical equivalence to control in removing protein from deposited lenses. | "The results indicated statistical equivalence between Test and Control." | |
| General Cleaning (Surfactant): Surfactant concentrations well above Critical Micelle Concentration (CMC). | "The surfactant concentrations are well above the CMC for the individual surfactants." This is a foundational aspect that supports cleaning efficacy. | |
| Cleanliness Analysis (Clinical Lens Returns) | Substantial equivalence in lens cleanliness between test and control regimens. | "The analysis of lens cleanliness from both Test and Control regimens indicates that these regimens are substantially equivalent when evaluated by Image Analysis." This suggests that the clinical performance regarding cleanliness was comparable to the control, likely a predicate device. |
| Lens Wettability | Continued presence of wetting agents over time; statistically significant longer wetting ability compared to controls. | "The results indicated statistical significance for longer wetting ability over the controls." This implies the solution improves or maintains lens wettability effectively. |
| Clinical Studies | Demonstration of safety and efficacy, and substantial equivalence to control (predicate device). | A 3-month controlled, randomized study designed to evaluate safety and efficacy was completed, "to demonstrate the safety and efficacy of the solution and substantial equivalence to the Control." The overall conclusion of the 510(k) is that the device is "substantially equivalent" to predicate devices. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Clinical Study: A "3-month controlled, randomized study" was conducted. However, the exact number of participants (sample size) for this clinical study is not specified in the provided text.
- Other Studies (Toxicology, Lens Compatibility, Microbiology, Cleaning Efficacy, Wettability): The sample sizes for these preclinical/laboratory studies are also not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given Bausch & Lomb's location (Rochester, New York, USA) and the FDA submission, it's highly probable the studies were conducted in or overseen by US-based operations. The studies described are original investigations conducted by the submitter, making them prospective for the purpose of this submission.
- Test Set Sample Size:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the number or qualifications of experts used to establish ground truth for any of the studies (e.g., for microscopy, image analysis, or clinical assessments). Ground truth for these types of products typically relies on standardized laboratory assays and clinical observations by trained personnel, but specific "experts" for ground truth adjudication are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method (like 2+1 or 3+1) is mentioned in the summary, as it's not typically relevant for the type of objective laboratory tests described or for the high-level summary of a clinical trial for a contact lens solution. Ground truth is generally established through the direct results of assays or clinical assessments.
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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 type of study is relevant for AI systems interpreting medical images, which is not the nature of this medical device (a contact lens solution). The device itself does not involve "readers" or "AI assistance" in the typical diagnostic sense.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a solution, not an algorithm. Performance is measured directly through its chemical, biological, and clinical effects, not through an algorithm's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth varied depending on the specific study:
- Toxicology: Likely based on objective measures of cell viability (cytotoxicity assays) and macroscopic/microscopic observation of ocular tissues (eye irritation studies).
- Lens Compatibility: Likely based on physical inspection of lenses after cycling, possibly optical properties, or other material science tests.
- Microbiology: Based on standardized quantitative microbial reduction assays as per FDA Guidance (e.g., log reduction of specific organisms).
- Cleaning Efficacy:
- Protein Deposition: Measured by "Image Analysis" of lenses, implying quantitative assessment of protein stains or residues.
- Protein Removal: Measured by "chemical analysis" of protein from deposited lenses.
- Surfactant Concentration: Measured by analytical chemistry methods (e.g., to determine CMC).
- Cleanliness Analysis (Clinical Lens Returns): "Evaluated by Image Analysis," similar to cleaning efficacy, but on clinically used lenses.
- Lens Wettability: Measured by "contact angle" and likely visual or physical assessments of wetting over time.
- Clinical Studies: Based on clinical observations (e.g., adverse events, comfort, visual acuity, lens condition) by eye care practitioners following established protocols.
- Overall, the ground truth leans heavily on objective laboratory measurements/assays and clinical observations/assessments, rather than expert consensus on a subjective measure.
- The ground truth varied depending on the specific study:
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The sample size for the training set:
- Not applicable. This device is a chemical solution, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, no ground truth was established for it.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”