(68 days)
The CONTACT LENS CASE ROUND GLASSES is intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.
The Contact Lens Case Round Glasses is leak-proof and made from durable plastic with secure, snap lids. Note: can be used with hard and soft contact lenses; for chemical disinfection only; rinse case thoroughly before initial use; replace contact case every 2 months. The secure snap lids are connected to the body by stainless steel hinges and securely close by use of the silicon seal within the plastic Each compartment has a capacity of 4,4ml and diameter of 26,5mm and an overall dimension of 76mm x 29mm x 17mm The Case body is in White Color and the Lids in Black Color with transparent windows. Contact lenses can be fully immersed in each compartment, and each compartment fit all standard lenses currently being sold in the market. The side of each compartment is marked with L (left) or R (right)
The document describes a contact lens case, not an AI device, so many of the requested criteria related to AI performance, such as MRMC studies, ground truth establishment, or training set size, are not applicable.
However, based on the provided text, I can extract the relevant information regarding the acceptance criteria and the study performed for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Anti-Leakage | None of the tested lens cases showed any leakage. All of the Leakage Test Passed Successfully. |
| Cytotoxicity | No cytotoxicity |
| Eye Irritation | No Eye Irritation |
| Systemic Toxicity | No systemic Toxicity |
2. Sample Size for Test Set and Data Provenance
- Anti-Leakage Test: 48 products (units of Contact Lens Case Round Glasses) were used. The provenance is internal testing performed by the manufacturer, FiftyTwoWavs Ltd, presumably in Hong Kong S.A.R. (based on their address). This appears to be a prospective test as it was performed on units of their product.
- Biocompatibility Tests (Cytotoxicity, Eye Irritation, Systemic Toxicity): The document states "All results show that the material is not cytotoxic, causes no eye irritation and has no systematic cytotoxic." However, it does not explicitly state the number of samples or the specific methodology/sample size used for these biocompatibility tests (ISO-10993-5, ISO 10993-10, ISO-10993-11). The results were submitted in the application.
3. Number of Experts and Qualifications
Not applicable for tests described (leakage, biocompatibility). These are laboratory/engineering tests, not expert-adjudicated clinical assessments.
4. Adjudication Method for Test Set
Not applicable. The tests performed are objective physical/chemical assessments (e.g., visual inspection for leakage, lab assays for biocompatibility).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a contact lens case, not an AI-assisted diagnostic or treatment device. No MRMC study was performed or is relevant. The submission explicitly states: "No Clinical Test Were Performed."
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (contact lens case), not an algorithm or software.
7. Type of Ground Truth Used
- Anti-Leakage: Empirical observation (visual inspection for liquid leakage).
- Biocompatibility: Established ISO standards (ISO-10993-5, ISO 10993-10, ISO-10993-11) for evaluating material safety. The "ground truth" is defined by the passing criteria of these standardized tests.
8. Sample Size for Training Set
Not applicable. This device is a physical product and does not involve AI/machine learning, therefore no training set is relevant.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this 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.”