(165 days)
The SAUFLON AEROTAB DISINFECTING SYSTEM is indicated for chemical disinfection and storage of clear (untinted) soft (hydrophilic) contact lenses.
The AEROSOLV UNPRESERVED BUFFERED SALINE SOLUTION is indicated for the rinsing of soft contact lenses after cleaning, dissolving of the Sauflon AEROTAB Disinfecting Tablet to make the disinfecting/ storage solution, and rinsing of the soft contact lenses prior to insertion onto the eye.
The SAUFLON Barrel Lens Case is to be used with the AEROSOLV UNPRESERVED BUFFERED SALINE SOLUTION and Sauflon AEROTAB Disinfecting Tablets as the lens case for chemical disinfection and storage of clear (untinted) soft (hydrophilic) contact lenses .
The SAUFLON barrel lens case may also be used as the lens case for storage of soft (hydrophilic) contact lenses during chemical disinfection only. DO NOT USE WITH HEAT OR HYDROGEN PEROXIDE SYSTEMS.
The Sauflon Aerotab Disinfecting Tablet contains halazone (4-carboxyphenyl N-chloro sulphonamide) as the active ingredient, with an effervescent base of adipic acid and anhydrous sodium carbonate. There is no preservative in the tablet. AEROSOLV Unpreserved Buffered Saline Solution is a sterile, aqueous, isotonic solution of sodium chloride buffered with boric acid and sodium borate.
The Sauflon AEROTAB disinfecting system was shown to be compatible with clear (untinted) soft (hydrophilic) contact lenses .
The Sauflon AEROTAB Disinfecting System (composed of the Sauflon AEROTAB Disinfecting Tablet, AEROSOLV Unpreserved Buffered Saline Solution, and Sauflon Barrel Lens Case) was evaluated through several studies to meet its acceptance criteria for chemical disinfection and storage of soft (hydrophilic) contact lenses.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Microbiology | Meets Stand-Alone Procedure for Disinfecting Products requirements | Efficacy maintained throughout labeled shelf-life | Microbiology |
| Clinical Safety (Adverse Reactions) | No adverse reactions | No adverse reactions observed | Clinical Trial |
| Clinical Safety (Ocular Findings) | Acceptable percentage of "no positive slit lamp findings" | 90% of eye examinations showed no positive slit lamp findings (compared to 67% for peroxide control) | Clinical Trial |
| Clinical Safety (Symptoms) | Acceptable percentage of "no symptoms reported" | 81% of visits reported no symptoms (compared to 85% for peroxide control, considered not significantly different) | Clinical Trial |
| Clinical Efficacy (Visual Acuity) | Appropriate visual acuity (within 2 Snellen lines of original best corrected acuity) | 95% of test eyes achieved appropriate visual acuity | Clinical Trial |
| Clinical Efficacy (Lens Cleanliness) | Acceptable percentage of "clinically clean" lenses | 93% of test lenses were clinically clean at scheduled visits | Clinical Trial |
| Toxicology (Cytotoxicity) | No cytotoxicity | No cytotoxicity reported for lenses disinfected for 30 cycles | Toxicology |
| Toxicology (Ocular Irritation) | No ocular irritation | No ocular irritation reported for lenses disinfected for 30 cycles | Toxicology |
| Toxicity (Lens Case Components) | Compliance with USP XXIII for Plastics for Ophthalmic Products | Components passed USP XXIII requirements | Toxicology |
| Lenses Compatibility | Compatibility with clear (untinted) soft (hydrophilic) contact lenses | Shown to be compatible | Product Description |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Trial: 334 subjects (276 test, 58 control). The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the provided text. However, the study involved a "6 month clinical trial," which typically implies a prospective design.
- Toxicology: Hydrophilic lenses representative of all four groups were disinfected for 30 cycles. The exact number of lenses is not specified.
- Microbiology: Not specified, but the "Stand-Alone Procedure for Disinfecting Products" would involve specific laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The provided text does not specify the number or qualifications of experts used to establish the ground truth for the test set. For the clinical trial, "no positive slit lamp findings" and "clinically clean" lenses likely involved evaluations by ophthalmologists or optometrists, but their specific qualifications or number are not detailed.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned. The clinical trial compared the Sauflon AEROTAB Disinfecting Tablet system to a "commercial peroxide disinfecting system," which is a comparison of two different disinfecting methods, not an AI assistance study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a chemical disinfecting system, not an AI algorithm. Therefore, the concept of an "algorithm only without human-in-the-loop performance" does not apply. The clinical and microbiological studies represent the "standalone" performance of the disinfecting system itself.
7. The Type of Ground Truth Used
- Clinical Trial: The ground truth for the clinical trial would be a combination of:
- Expert Clinical Assessment: Slit lamp findings, visual acuity measurements (likely by trained professionals), and assessment of lens cleanliness.
- Patient-Reported Outcomes: Symptoms reported by subjects.
- Toxicology: Expert assessment of cytotoxicity and ocular irritation (e.g., cell viability assays, animal models or in-vitro tests for ocular irritation).
- Microbiology: Laboratory testing according to the "Stand-Alone Procedure for Disinfecting Products," which would have defined metrics for microbial kill.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a physical medical device (disinfecting system), not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.”