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The applicant contact case is to be used by the contact lens wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses while not in use. Intended for chemical disinfection only. Not designed for heat disinfecting system.

The AC Branded Contact Lens Cases consists of a lens case base with dual adjoining wells for the containment of fluid. The case cover are two screw top caps. All the variant models have a capacity of over 3.0 ml in each case well, thus, any contact lens can be fully immersed into the chambers.

The provided document is a 510(k) premarket notification for a contact lens case, not a device that would typically have performance metrics measured like AI/ML algorithms or diagnostic devices. A contact lens case is typically evaluated based on its materials, design, and adherence to established standards for storing and chemically disinfecting contact lenses. The 510(k) essentially argues that the new device is "substantially equivalent" to an already legally marketed device (predicate device).

As such, the detailed information requested in your prompt (e.g., acceptance criteria with reported device performance in specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the equivalence argument, which serves as the "study" for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (contact lens case), the "acceptance criteria" are essentially the characteristics of the predicate device, and the "reported device performance" is the demonstration that the applicant's device matches these characteristics, thereby establishing substantial equivalence.

Conclusion of Equivalence: The applicant device has the same classification information, uses the same materials (with only a colorant difference noted explicitly), and has a similar design as the predicate device.

The following points are Not Applicable (N/A) for this 510(k) submission of a contact lens case:

2. Sample size used for the test set and the data provenance: N/A. There isn't a "test set" in the traditional sense for performance evaluation like in AI/ML. The "test" is a comparison of product specifications and features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth in this context refers to the established standards and specifications for contact lens cases, not an assessment by human experts on individual cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. No adjudication method for a test set is described or relevant for this type of device.

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: N/A. This is a contact lens case, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used for this submission is the established regulatory requirements for contact lens cases and the characteristics of the legally marketed predicate device. The claim is one of substantial equivalence based on identical intended use, materials, and design.

8. The sample size for the training set: N/A. There is no training set mentioned or relevant for this type of device.

9. How the ground truth for the training set was established: N/A. There is no training set for this type of device.

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