Search Results

For storage of soft (hydrophilic), rigid gas permeable (RGP), and hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.

The Bonasse contact lens cases are molded plastic, flat or barrel style cases with screw top lids, similar in design to currently marketed products. The barrel styles include a lens basket used for holding the lens during storage.

The provided text is a 510(k) summary for contact lens cases, not a study evaluating a medical device's performance against acceptance criteria. It primarily focuses on establishing substantial equivalence to a predicate device. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating "substantial equivalence."

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with quantitative thresholds. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implied by similarity to the predicate.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. No clinical or performance test set (as would be used for an AI/diagnostic device) is described. The evaluation is based on a comparison of design, materials, and intended use to a predicate device.
• Data Provenance: Not applicable. The comparison is based on device characteristics rather than a study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts is described as this is a device for contact lens storage, not a diagnostic or AI device requiring expert interpretation of results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described as there is no test set or expert interpretation involved.

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 document describes contact lens cases, not an AI-assisted diagnostic or interpretation tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical contact lens case, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a contact lens storage case, the "ground truth" for safety and effectiveness is largely established through material biocompatibility and design similarity to existing safe and effective products.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device.

9. How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

Summary of the Study/Evaluation Performed:

The "study" presented here is a comparison to a predicate device to establish substantial equivalence.

• Non-Clinical Tests: Biocompatibility testing was performed by a third-party laboratory to demonstrate the materials are safe for use. This can be considered a "performance test" for the materials.
• Clinical Tests: None were performed.
• Conclusion: The Bonasse Contact Lens cases are deemed safe and effective for their intended use based on their similarity in design, materials, and intended use to the Alcon Opti-Free contact lens case, and positive biocompatibility testing of the materials.

Ask a specific question about this device