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For storage of soft (hydrophilic), hard and rigid gas permeable contact lenses during chemical disinfection. Use for storage during chemical disinfection only. DO NOT USE WITH HEAT.

The Contact Lens Case is a simple device made with a polypropylene base and a polyethylene lid to store soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. This device is manufactured only for chemical disinfections with approved chemical cleaning agents to clean contact lenses.

The physical style is simple with a base volume of 4.8 milliliter and dimensions of 6.25 mm wide and 9.25 mm high. This provides sufficient space to insert and retrieve the contact lenses. It also provides sufficient space to introduce the chemical cleaning solution and adequately cover the lenses for cleaning.

The provided text is related to a 510(k) premarket notification for a Contact Lens Case. It outlines the device description, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria and detailed study that proves the device meets those criteria, as typically seen for AI-based medical devices.

The information provided describes a physical medical device (contact lens case), not an AI or algorithm-based device. Therefore, the questions related to AI performance metrics (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and effect size improvements) are not applicable to this document. The provided text details testing for biocompatibility and leakage, which are relevant for a physical contact lens case.

Here's an attempt to answer the questions based only on the provided text, recognizing the mismatch with typical AI/algorithmic device data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Biocompatibility Testing: The text mentions "L929 mouse fibroblast cells" for cytotoxicity, "guinea pig" for skin sensitization, and "mouse" for systemic toxicity. The specific number of cells or animals used as a "sample size" is not provided.
• Leakage Testing: 240 combinations of different tops and bottoms were tested.
• Data Provenance: Not explicitly stated, but the tests were conducted according to ISO standards, implying laboratory testing. The manufacturing company is in China, so it's likely the testing was conducted there or by a certified lab. The data is prospective in the sense that the manufacturer conducted these tests specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable. The "ground truth" for these tests (cytotoxicity, irritation, systemic toxicity, leakage) is objective biological responses or physical observation, not expert interpretation of medical images or data.

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

• This question is not applicable. Adjudication methods are typically used for subjective assessments where multiple experts might disagree (e.g., classifying medical images). The tests performed are objective laboratory and physical tests.

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 or algorithmic device.

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 AI or algorithmic device.

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

• The "ground truth" for the biocompatibility tests involved observable biological responses in cells and animals (e.g., cell viability, irritation scores, systemic effects). For leakage testing, the ground truth was the observable absence or presence of liquid leakage.

8. The sample size for the training set

• Not applicable. This device is a physical contact lens case, not an AI or algorithmic device that requires a training set.

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

• Not applicable. This device is a physical contact lens case, not an AI or algorithmic device that requires a training set.

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