(147 days)
Bausch + Lomb® NNR06 Multi-Purpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.
Bausch + Lomb NNR06 Multi-Purpose Solution is a sterile, isotonic solution containing a triple disinfection system (polyaminopropyl biguanide 0.00005%, polyquaternium 0.00015% and alexidine 0.0002%), dual surfactants, poloxamine, poloxamer 181, and a novel buffering system consisting of edetate disodium, sodium citrate, and diglycine. The formulation also contains boric acid, sodium borate, sodium chloride and purified water. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
The provided text describes the Bausch + Lomb NNR06 Multi-Purpose Solution, a soft contact lens care product. It outlines the testing performed to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical AI/ML medical device submission might. Instead, it describes a series of preclinical and clinical tests whose results demonstrated that the device met the requirements for safety and effectiveness.
Here's an interpretation of the implied acceptance criteria and reported performance based on the provided text:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Met |
| Ocular irritation | Met |
| Oral toxicity | Met |
| Sensitization | Met |
| In vivo ocular biocompatibility | Met |
| Microbiology: | |
| Disinfection efficacy | Exceeds criteria |
| Preservative efficacy | Exceeds criteria |
| Acanthamoeba encystment | Demonstrated efficacy (implied) |
| Sterilization method for production | Assessed and implies effectiveness |
| Lens Compatibility: | |
| Physical compatibility with soft contact lenses | Compatible |
| Compatibility with silicone hydrogel contact lenses | Compatible |
| Preservative uptake and release | Demonstrated (implies acceptable levels) |
| Cleaning Efficacy: | |
| Critical Micelle Concentration | Surfactant concentrations well above CMC |
| Protein deposit removal (in vitro) | Demonstrated cleaning properties |
| Clinical Safety: | |
| Slit lamp findings (primary endpoint) | Achieved (implies acceptable findings) |
| Adverse events | No reported adverse events |
| Visual acuities | Similar between eyes of both groups |
| Slit lamp findings, symptoms requiring medical treatment, comparison of visual acuities, absence of adverse events | Indicate safety |
| Clinical Effectiveness: | |
| Comfort-related symptoms/complaints | Indicate effectiveness |
| Investigator-assessed lens wettability | Indicate effectiveness |
| Investigator-assessed lens deposits | Indicate effectiveness |
| Overall Comparison to Predicate: | Similar safety and effectiveness profiles |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document states that a "controlled clinical study" was conducted with "habitual contact lens wearers." However, it does not specify the exact sample size for the clinical study.
- Data Provenance: The document does not explicitly state the country of origin where the clinical study was conducted. It mentions that the study was "a three-month, active control, parallel group, masked randomized study of habitual contact lens wearers," indicating it was a prospective clinical study.
3. Number and Qualifications of Experts for Ground Truth
This information is not applicable as the document describes a contact lens solution, not an AI/ML device that would typically rely on expert-established ground truth for its performance assessment. The "ground truth" for this device's performance comes from validated laboratory tests and clinical outcomes assessed by investigators (e.g., observing slit lamp findings, assessing comfort).
4. Adjudication Method for the Test Set
Not applicable in the context of this type of device and study. The clinical study involved investigator assessments, which would follow a protocol but not an independent adjudication method for ground truth as seen in AI/ML performance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools to assess performance with and without AI assistance for human readers, which is not the nature of this device.
6. Standalone Performance Study
The reported clinical study is effectively a "standalone" outcome study for the device, in the sense that it evaluates the device's performance on its own (in comparison to an active control, rather than an AI-assisted human). The device itself (NNR06 Multi-Purpose Solution) is not an AI algorithm, so the concept of an "algorithm only without human-in-the-loop performance" doesn't directly apply here. The safety and effectiveness were assessed based on user experience and clinical findings.
7. Type of Ground Truth Used
For the clinical study, the "ground truth" (or outcome measures) included:
- Clinical Observations: Graded slit lamp findings, visual acuities, investigator-assessed lens wettability, investigator-assessed lens deposits.
- Patient Reported Outcomes: Comfort-related symptoms/complaints.
- Adverse Events Reporting: Absence or presence of adverse events.
For the preclinical studies, the "ground truth" was established by validated laboratory test methods and international standards (e.g., ISO, EN ISO standards) for biocompatibility, microbiology, cleaning efficacy, and lens compatibility.
8. Sample Size for the Training Set
Not applicable. This device is a contact lens solution, not an AI/ML algorithm that requires a training set. The "development" of the solution would involve chemical formulation and laboratory testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is not an AI/ML device, and therefore no training set or its associated ground truth establishment methods are relevant.
§ 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.”