(88 days)
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider. It is also indicated for use in dissolving enzymatic cleaning tablets.
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is a multi-purpose solution used in the care of soft (hydrophilic) contact lenses and is indicated for the cleaning, rinsing, disinfection and storage of soft (hydrophilic) contact lenses. It may also be used as a diluent for enzymatic cleaning tablets which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablets. The solution is contained in a plastic bottle and consists of a sterile isotonic solution that contains boric acid, edetate disodium, poloxamine. sodium borate and sodium chloride; it is preserved with alexidine dihydrochloride 4 ppm. Each plastic bottle is supplied sterile and is labeled with a lot number and expiration date.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested.
Device: BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Disinfection Cycle Time: Disinfection equivalent to predicate device with a 10-minute cycle time. | Satisfactory microbiological testing results at time periods ranging from 10 minutes to 240 minutes. |
| Cleaning, Rinsing, Disinfection, and Storage: Safe and efficacious for these uses for soft (hydrophilic) contact lenses. | Safety and efficacy demonstrated through previous clinical and preclinical testing submitted under K973921. |
| Use as Diluent for Enzymatic Cleaning Tablets: Safe and efficacious for dissolving enzymatic cleaning tablets. | No specific performance outcome detailed for this, but implied as part of overall safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the microbiological testing supporting the 10-minute disinfection claim.
- Data Provenance: The document does not specify the country of origin. The study appears to be prospective as it states "a series of microbiological testing has been completed at time period ranging from 10 minutes to 240 minutes" specifically to support the new 10-minute disinfection claim. The general safety and efficacy studies for the overall cleaning, rinsing, etc., were retrospective as they were previously submitted under K973921.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. (Presumably, these would be microbiology experts if external involvement beyond internal lab expertise was required).
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The testing described is microbiological efficacy testing, not observational or diagnostic assessment requiring expert adjudication. The results are likely quantitative measurements against specific microbial reduction standards.
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:
- MRMC Study: No. This is a medical device (contact lens solution), not an AI diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Test: Not applicable. This is a chemical solution, not an algorithm. The "standalone" performance here refers to the solution's efficacy against microbes.
7. The Type of Ground Truth Used:
- Ground Truth: Microbiological efficacy standards (e.g., specific log reduction of various microorganisms as per ISO or FDA guidelines for disinfection solutions). The document states "All results were satisfactory," implying they met predefined standards.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was established:
- Ground Truth Establishment: Not applicable.
§ 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.”