(207 days)
BAUSCH + LOMB EZS05 Disinfecting Solution is indicated for disinfecting, protein removal, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.
BAUSCH + LOMB EZS05 Disinfecting Solution is a sterile, buffered 3% hydrogen peroxide solution with a phosphonic acid stabilizer, sodium chloride and phosphate buffers. A special lens case containing a platinum coated neutralizing disc is provided with the EZS05 Disinfecting Solution. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labelled with a lot number and expiration date
The document describes the acceptance criteria and supporting studies for the BAUSCH + LOMB EZS05 3% Hydrogen Peroxide Disinfecting Solution. This is a contact lens care product, and the studies are primarily pre-clinical (in vitro and laboratory-based) to demonstrate safety and effectiveness for its intended use.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a contact lens solution, the performance isn't measured in typical diagnostic metrics (like sensitivity/specificity). Instead, it's evaluated against specific quality and efficacy standards for contact lens care products. The acceptance criteria are implied by the standards referenced and the statement of meeting those criteria.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA Guidance for Contact Lens Solutions and Accessory Products (May 1997), GLP requirements, recognized testing Standards for cytotoxicity, ocular irritation, and sensitization. | Non-cytotoxic, not an ocular irritant, not a sensitizing agent. |
| Microbiology (Disinfection) | EN ISO 14729:2001 (Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods). | Meets criteria for disinfection. |
| Microbiology (Preservative Efficacy) | EN ISO 14730:2000 (Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date). | Meets criteria for preservative efficacy. |
| Lens Compatibility | Compatibility with soft contact lenses including silicone hydrogel contact lenses. (No specific standard cited, but implied by need for compatibility) | Compatible with soft contact lenses including silicone hydrogel contact lenses. |
| Protein Removal | Efficacy statistically equivalent to predicate device (Ciba Clear Care Cleaning and Disinfecting Solution) on various lens types (Polymacon, Etafilcon A, Galyfilcon A, Balafilcon A) for lysozyme removal. | Statistically equivalent to the predicate device, Ciba Clear Care Cleaning and Disinfecting Solution. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility, Microbiology, Lens Compatibility: No specific sample sizes for these studies are provided in terms of "test set" and "training set" as these are not machine learning models. These are laboratory-based, pre-clinical studies where samples would refer to test reagents, lens materials, microbial cultures, and animal models or in-vitro cell cultures. No country of origin for the data is mentioned, but testing was performed under Good Laboratory Practice requirements and adhered to international ISO standards. These were likely retrospective analyses of laboratory test results.
- Protein Removal: The study involved in vitro deposition of lysozyme on Polymacon, Etafilcon A, Galyfilcon A, and Balafilcon A Soft Contact Lenses. The exact number of lenses used for each type is not specified but implies multiple lenses to achieve statistical equivalence. The data provenance is from in vitro testing, not human subjects, so geographic origin is not directly relevant. It is a laboratory-based study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for these pre-clinical studies is established by standardized laboratory methods, physical/chemical measurements, and microbiological assays, not by human expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. There's no human interpretation or subjective assessment involved that would require adjudication. The outcomes are objective laboratory measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a contact lens solution, and its effectiveness is determined through laboratory and in vitro testing, not by human readers interpreting clinical cases. The document explicitly states that "Clinical Studies are not warranted" given the market history of peroxide solutions and the FDA guidance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is geared towards AI/ML devices. Since this is a chemical preparation (contact lens solution), the concept of "standalone (algorithm only)" performance does not apply. The device itself is the "standalone" product that performs its function without human intervention during the disinfection process.
7. The Type of Ground Truth Used
- Biocompatibility: In-vitro cell assays for cytotoxicity, animal models or in vitro tests for ocular irritation and sensitization.
- Microbiology: Standardized microbiological culture methods to determine microbial reduction and preservative efficacy.
- Lens Compatibility: Laboratory assessment of lens material integrity and optical properties after exposure to the solution.
- Protein Removal: Quantitative chemical analysis (HPLC assay for total protein) of lysozyme remaining on contact lenses after treatment.
8. The Sample Size for the Training Set
Not applicable. These are pre-clinical laboratory studies, not machine learning or AI algorithm development, so there isn't a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The methodology involves adherence to established international and FDA standards for laboratory testing.
§ 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.”