(15 days)
The API Soft Grip, 68012, 68013; Deluxe, K1020; and Econo-Mate, K1010 Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.
The API Soft Grip Contact Lens Cases and Deluxe Contact Lens Cases are designed for storage of contact lenses with adjoining dual wells that have screw top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The Econo-Mate Contact Lens Cases have two adjoining wells with integral hinged, self-sealing caps in which respective contact lenses are immersed. The cases are also labeled with an 'R' or 'L' to distinguish right and left lenses. The cases are available in a variety colors.
The document provided is a 510(k) Summary for a contact lens case, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance, are not applicable.
However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Attribute | Acceptance Criteria (from "test plan") | Reported Device Performance |
|---|---|---|
| Leak Test | Effective against leaking | All Soft Grip, Deluxe, and Econo-Mate contact lens cases meet leak test criteria and have demonstrated to be effective against leaking. |
| Biocompatibility | Safe for use in contact lens storage and disinfection | Demonstrated the materials are safe for use in contact lens storage and disinfection. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "All Soft Grip, Deluxe, and Econo-Mate contact lens cases" were subjected to the leak test, implying a representative sample of each model, but the exact number is not provided.
- Data Provenance: The document does not specify country of origin for the test data. The tests were performed by "third-party laboratories" for biocompatibility and presumably internally or by a third party for the leak test. The study appears to be prospective testing of newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is Not Applicable as the device is a contact lens case, not an AI/ML device requiring expert ground truth for image or data interpretation. Biocompatibility testing relies on standardized protocols and laboratory analysis, not expert consensus in the typical sense of AI/ML evaluation.
4. Adjudication Method for the Test Set
- This question is Not Applicable. Performance (e.g., leak integrity, biocompatibility) is determined through empirical testing and analytical methods, not through an adjudication process like those used for expert review of AI/ML output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- This question is Not Applicable. MRMC studies are used for evaluating diagnostic or prognostic devices often involving human readers and AI assistance. This device is a contact lens case for storage.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is Not Applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through physical and chemical testing standards.
- For the leak test: The "ground truth" is whether the case physically leaks under specified conditions.
- For biocompatibility: The "ground truth" is adherence to established biocompatibility standards and tests (e.g., ISO 10993 series or equivalent) to determine material safety.
8. The Sample Size for the Training Set
- This question is Not Applicable. This device is a manufactured product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is Not Applicable. As stated above, this is a physical product, not an AI/ML model requiring a training set.
§ 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.”