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The PROSBEN Contact Lens Cases are intended for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. For use during chemical disinfection only; not to be used with heat.

The PROSBEN Contact Lens Case is the subject of this 510(k) premarket notification. The Contact Lens Case is a lens care product to be used the contact lens wearer or practitioner for storing contact lenses while not being worn. The PROSBEN Contact Lens Cases are designed for use in chemical disinfection only; not to be used with heat. The PROSBEN Contact Lens Cases are not including the disinfection, only for shipping the cases in a dry state.

The provided text describes the PROSBEN Contact Lens Cases and its 510(k) submission to the FDA. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device (i-Promotions Contact Lens Case, K042578) through safety data (biocompatibility tests) and a comparison of design and materials.

Crucially, the document does not describe a study involving a test set, expert ground truth, or statistical analysis of device performance against acceptance criteria in the manner typically expected for AI/algorithm-based devices. The "device" in this context is a physical product (contact lens cases), not a software algorithm that outputs a diagnostic or predictive result.

Therefore, many of the requested sections (2-9) are not applicable or cannot be extracted from the provided text because the nature of the device and its evaluation are different from what your prompt anticipates for an AI/algorithm.

Here's an attempt to answer based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria:
The acceptance criteria are derived from the safety tests conducted per ISO 10993 standards for biological evaluation of medical devices. The "reported device performance" indicates that the PROSBEN Contact Lens Cases successfully met these criteria, concluding they are safe for their intended use. The substantial equivalence claim is also a key "acceptance criterion" met by demonstrating similar intended use, working principle, and technologies to a legally marketed predicate device, with differences not impacting safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for the biological evaluations. These tests are typically performed on samples of the manufactured material or final product.
• Data Provenance: Not explicitly stated, but the tests were performed on the PROSBEN Contact Lens Cases themselves. The 510(k) summary is prepared in Taiwan (R.O.C.), implying the testing might have been conducted there or by affiliated labs. The data is internal to the manufacturer for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

• Not applicable. For biological and material compatibility tests, the "ground truth" is established by the test protocols and objective measurements (e.g., cell viability, presence/absence of an irritation response) following international standards (ISO 10993). Expert interpretation would be involved in designing and analyzing results, but not in establishing a "ground truth" in the way it's done for diagnostic AI algorithms based on expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. As above, the evaluation relies on standardized test methods and objective metrics rather than expert adjudication of cases/images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. This type of study is relevant for diagnostic imaging or similar interpretation tasks where human readers' performance is augmented by AI. The PROSBEN Contact Lens Case is a physical medical device for storage; therefore, an MRMC study is not applicable.

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

• Not applicable. This device is a physical product, not a software algorithm.

7. The type of ground truth used

• For the biological evaluations (cytotoxicity, irritation, systemic toxicity), the ground truth is based on standardized laboratory test results and established scientific criteria as defined by ISO 10993. For demonstrating substantial equivalence, the "ground truth" is the legally marketed status and characteristics of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this physical device evaluation.

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

• Not applicable. As no training set exists, no ground truth needed to be established for it.

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