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For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.

The Alcon Contact Lens Case is intended for use for soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. It consists of a side by side double well plastic case with two screw-on plastic closures.

The provided text is a 510(k) summary for the Alcon Contact Lens Case. It describes the device, its intended use, and its performance characteristic. However, it is a pre-market notification to establish substantial equivalence to existing devices and does not present a study with statistical acceptance criteria or detailed performance metrics in the way a clinical trial for a novel AI device would.

Here's an analysis of the information, noting what is present and what is absent based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a physical medical device (contact lens case) and not a diagnostic AI or imaging device that would typically involve a "test set" of patient data. The performance claims relate to physical properties and material safety, not diagnostic accuracy.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant for this device. The "ground truth" would effectively be the physical properties and material safety standards, which are evaluated through laboratory tests rather than expert interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication related to diagnostic accuracy is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is for evaluating the impact of an AI system on human reader performance, which is not relevant for a contact lens case.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This device is not an algorithm. Its performance is inherent in its physical design and material properties.

7. Type of Ground Truth Used

• The "ground truth" for the performance claims would be based on physical measurements (e.g., volume capacity) and laboratory testing to assess physico-chemical and toxicological properties of the materials. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set mentioned, this question is not relevant.

Summary of Study Described:

The document describes the design and intended performance characteristics of the Alcon Contact Lens Case and establishes its substantial equivalence to previously cleared devices (OPTI-FREE® Lens Case (K931620) and OPTI-LENS® Lens Case (K915082)). The "study" here is more accurately a demonstration that the device design meets certain functional requirements (like overflow capacity) and that the materials used are safe. This is fundamentally different from a clinical study for a diagnostic device. The basis for acceptance is primarily meeting regulatory requirements for substantial equivalence based on similar design and materials, rather than a clinical trial demonstrating a specific performance endpoint against a defined ground truth.

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