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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 storage of 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.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not include information about the specific sample size used for testing the overflow capacity.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, the context suggests the testing was likely conducted by Alcon Laboratories, Inc. in the US given their submission to the FDA.

3. Number and Qualifications of Experts for Ground Truth

The provided text does not indicate that experts were used to establish ground truth for the device's performance. The acceptance criterion is a quantifiable engineering specification related to volume.

4. Adjudication Method

The provided text does not mention any adjudication method as external expert review was not indicated for this type of performance evaluation.

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

A MRMC comparative effectiveness study was not performed as this device is a contact lens case, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance (Algorithm Only)

Standalone performance is not applicable as this device is a physical product (contact lens case), not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth for the performance claim (overflow capacity) is based on engineering specifications and design requirements. It's a direct measurement of the physical design, not expert consensus, pathology, or outcomes data.

8. Sample Size for Training Set

A training set sample size is not applicable as this device is a physical product, not an AI/ML algorithm.

9. How Ground Truth for Training Set Was Established

The concept of a "training set" and establishing ground truth for it is not applicable to this device. The performance is based on the physical design and manufacturing specifications of the contact lens case.

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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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