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"CAREUS Contact Lens Case" is a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.

"CAREUS Contact Lens Case" is a medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. "CAREUS Contact Lens Cases" have six different models, differ in dimension, case color, and packaging. The exterior of the cases total have 9 colors: white, pink, yellow, green, light green, red, purple, blue, and transparent (no color). Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right). CAREUS Contact Lens Cases are made of polypropylene.

The provided document is a 510(k) Summary for the "CAREUS Contact Lens Case." It describes a medical device, not a device that relies on algorithms for its function. Therefore, most of the requested information regarding acceptance criteria, study details, and AI/algorithm-related aspects is not applicable to this submission.

Here is the information that can be extracted from the document:

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

The document broadly states that "All tests were verified to meet acceptance criteria" for bench testing and biocompatibility. However, it does not provide specific numerical acceptance criteria or detailed reported performance figures for the physical and chemical specifications.

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

The document does not specify the sample sizes for the bench testing or biocompatibility tests. It only states that testing was performed. The manufacturing country of origin for the device is China (Shanghai Care Us Medical Product Co., Ltd., Shanghai, China). The testing itself is not explicitly stated as retrospective or prospective, but bench and biocompatibility testing are generally prospective in nature for a new device submission.

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. This device is a physical contact lens case and does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy, as would be relevant for an AI/algorithm-based device.

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

Not applicable. This concept applies to studies where expert interpretation is being evaluated, which is not the case for a contact lens storage 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:

Not applicable. This device does not 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 does not have an algorithm.

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

For the bench testing, the "ground truth" would be the predetermined physical and chemical specifications. For biocompatibility, the "ground truth" is adherence to the standards defined by ISO 10993. These do not fall into the categories of expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set:

Not applicable. This device is not an algorithm and does not have a training set.

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

Not applicable. This device is not an algorithm and does not have a training set.

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