(55 days)
BAUSCH & LOMB® Wetting and Soaking Solution is indicated for use in disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.
BAUSCH & LOMB Wetting and Soaking Solution is a sterile conditioning solution used in the care of rigid gas permeable and hard (PMMA) contact lenses and is indicated for the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses. This product is contained in a plastic bottle, and consists of a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
The provided text describes the acceptance criteria and the studies conducted for the BAUSCH & LOMB® Wetting and Soaking Solution to demonstrate its safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Toxicology | In-Vitro Cytotoxicity | Meets the requirements of the USP XXII Agar Diffusion Test. |
| Acute Ocular Irritation | Produced no ocular irritation. | |
| Microbiology | Preservative Effectiveness | Meets the relevant preservative efficacy requirements after 36 months at room temperature. |
| Disinfection Efficacy | Meets the ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements after 36 months at room temperature. | |
| Shelf Life | Expiration Dating | Established based on 36 months room temperature data. |
| Solution Compatibility | Lens Parameters (30 cycles with cleaner) | All physical and lens parameters were within ISO specifications for rigid corneal and scleral contact lenses. No change in cosmetic appearance. |
| Wetting Angle | Dynamic Contact Angle (DCA) Analysis | Equivalent behavior to the currently marketed BAUSCH & LOMB Wetting and Soaking Solution. |
| Substantial Equivalence | Formulation, Indications, Usage, Manufacturing | Formulated similarly, with the same indications, usage, and all aspects of manufacturing as the predicate device. |
2. Sample sized used for the test set and the data provenance
- Toxicology (In-Vitro Cytotoxicity, Acute Ocular Irritation): The sample size for these tests is not explicitly stated, but they are described as "preclinical testing" using "laboratory animals" for the ocular irritation test, implying a controlled laboratory study. Data provenance is implied to be domestic (likely US) as it's for a US regulatory submission. The tests are retrospective in the sense that they were completed preclinical studies.
- Microbiology (Preservative Effectiveness, Disinfection Efficacy): The tests were performed on "Product stored up to 36 months at room temperature." The specific number of product samples tested is not provided, but it's a prospective stability study over 36 months. Data provenance is implied to be domestic.
- Solution Compatibility: "BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses" were subjected to a thirty-cycle study. This implies samples of these specific lens types were used. The number of individual lenses or repetitions is not specified. Data provenance is implied to be domestic.
- Wetting Angle: The study investigated "three selected RGP lens materials, BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses." The number of lenses or repetitions per material is not specified. Data provenance is implied to be domestic.
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 described are primarily analytical, microbiological, and animal-based preclinical tests, not human-reader-based evaluations that would require expert ground truth establishment in the traditional sense of medical image analysis or diagnostics.
4. Adjudication method for the test set
This information is not applicable as the studies are preclinical, analytical, and microbiological, and do not involve human interpretation or adjudication in the context of diagnostic performance.
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
This type of study was not done. The submission is for a contact lens wetting and soaking solution and does not involve AI or human readers for diagnostic effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a contact lens solution, not an algorithm, and does not have standalone or human-in-the-loop performance in the context of AI.
7. The type of ground truth used
- Toxicology: "Ground truth" for cytotoxicity and ocular irritation would be based on established biological and physiological responses in validated in-vitro assays (USP XXII Agar Diffusion Test) and animal models (Acute Ocular Irritation test), demonstrating the absence of harmful effects.
- Microbiology: "Ground truth" for preservative effectiveness and disinfection efficacy is defined by meeting "relevant preservative efficacy requirements" and "ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements," respectively, which are predefined quantitative targets for microbial reduction.
- Solution Compatibility: "Ground truth" is based on adherence to "ISO specifications for rigid corneal and scleral contact lenses" and subjective assessment of "cosmetic appearance" after a specified number of cleaning and soaking cycles.
- Wetting Angle: "Ground truth" is established by comparing the Dynamic Contact Angle (DCA) analysis results of the modified solution to the legally marketed predicate device, aiming for equivalence.
8. The sample size for the training set
This information is not applicable as the studies are for a medical device solution and do not involve machine learning algorithms that require training sets. There is no mention of a "training set" in the document.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned or implied in the context of this device and its studies.
§ 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.”