(67 days)
For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.
The Alcon Contact Lens Case is intended for use for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. It consists of a side by side double well plastic case with two screw-on plastic closures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overflow capacity of 5.0 mL in each lens well | Designed to have an overflow capacity of 5.0 mL in each lens well to assure sufficient immersion of contact lenses under use conditions. |
2. Sample Size and Data Provenance
The provided text does not include information about the specific sample size used for testing the overflow capacity.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, the context suggests the testing was likely conducted by Alcon Laboratories, Inc. in the US given their submission to the FDA.
3. Number and Qualifications of Experts for Ground Truth
The provided text does not indicate that experts were used to establish ground truth for the device's performance. The acceptance criterion is a quantifiable engineering specification related to volume.
4. Adjudication Method
The provided text does not mention any adjudication method as external expert review was not indicated for this type of performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed as this device is a contact lens case, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone Performance (Algorithm Only)
Standalone performance is not applicable as this device is a physical product (contact lens case), not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth for the performance claim (overflow capacity) is based on engineering specifications and design requirements. It's a direct measurement of the physical design, not expert consensus, pathology, or outcomes data.
8. Sample Size for Training Set
A training set sample size is not applicable as this device is a physical product, not an AI/ML algorithm.
9. How Ground Truth for Training Set Was Established
The concept of a "training set" and establishing ground truth for it is not applicable to this device. The performance is based on the physical design and manufacturing specifications of the contact lens case.
§ 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.”