(14 days)
The Voguestrap 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. Not to be used with hydrogen peroxide disinfection systems.
The Voguestrap Contact Lens Cases are plastic cases designed such that thev are flat storage cases that have either screw top caps or flip top caps. The cases are labeled with an 'R' or 'L' to distinguish right and left lenses. The cases also come in different colors. The screw top model may also have a magnifying glass.
The provided text describes a 510(k) summary for the Voguestrap Contact Lens Cases. However, it does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed methodology.
Here's a breakdown of what can and cannot be extracted from the given text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics or thresholds.
- Reported Device Performance: The document only states, "Biocompatibility testing performed by third party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection." This is a qualitative statement of safety rather than a performance metric against a specific acceptance criterion.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not available | Not available |
| (e.g., Biocompatibility safety limits) | Materials demonstrated safe for use in contact lens storage and disinfection. |
2. Sample size used for the test set and the data provenance:
- The document does not specify a sample size for any test set or the provenance of any data beyond indicating "third party laboratory" for biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set requiring expert ground truth establishment for this type of device (contact lens case).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set involving human interpretation and adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical contact lens case, not an AI software or system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical contact lens case, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly defined. For the biocompatibility testing, the "ground truth" would implicitly be the established safety standards and regulations for materials in contact with biological tissues, interpreted by the third-party laboratory.
8. The sample size for the training set:
- Not applicable. No machine learning or AI training set is involved.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning or AI training set is involved.
Summary of available information:
The provided 510(k) summary for the Voguestrap Contact Lens Cases focuses on demonstrating substantial equivalence to a predicate device (Bonasse Contact Lens case K991206). The primary "test" mentioned is "Biocompatibility testing performed by third party laboratory," which concluded that "the materials are safe for use in contact lens storage and disinfection." This type of submission relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a de novo study with specific acceptance criteria as might be seen for more complex diagnostic or therapeutic devices.
§ 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.”