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For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.

The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement.

This document is a 510(k) summary for the NovaBay Pharmaceuticals, Inc. iCase Contact Lens Case. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

Based on the provided text, the device is an iCase Contact Lens Case. The "acceptance criteria" discussed are primarily related to safety, functionality, and meeting regulatory standards for medical devices, rather than a quantifiable performance metric for an AI or imaging device.

Here's an attempt to extract and format the requested information, acknowledging that many fields will be "Not Applicable" (N/A) due to the nature of this submission (a medical device accessory designed for safety and usability, not an AI or diagnostic tool):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each criterion. The evaluation appears to be based on engineering tests, risk analyses, and compliance with standards rather than a statistical "test set" of consumer usage or adverse events.
• Data Provenance: The studies mentioned (Biocompatibility, Electrical Safety, Software Validation, Cycling studies, Peroxide Degradation measurements, Risk Analysis, Device Hazard Analysis, Corrosion testing) were conducted by NovaBay Pharmaceuticals, Inc. (the applicant). The country of origin of the data is not specified beyond being generated by the applicant for FDA submission. It is retrospective data collected to support the premarket notification.

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

• Number of Experts: N/A. This device is not an AI/diagnostic tool requiring expert-established ground truth for performance evaluation in a clinical sense. The "ground truth" here is adherence to engineering standards, safety requirements, and functional specifications established through recognized testing methods.
• Qualifications of Experts: N/A for the same reason. The expertise lies within the engineering, regulatory, and quality teams involved in designing, testing, and submitting the device.

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

• Adjudication Method: N/A. Not applicable to engineering and regulatory compliance testing.

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

• MRMC Study: No. This is a contact lens case, not an imaging or diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: N/A. While the iCase has integrated electrical components and software to monitor peroxide neutralization and indicate cycle status, it's a functional device, not an "algorithm" in the sense of an AI model being evaluated for standalone performance. Its performance is intrinsically linked to the chemical process it monitors and its physical design.

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

• Type of Ground Truth: For this device, the "ground truth" is defined by:
  • Regulatory Standards: ISO biocompatibility standards, IEC electrical safety standards, FDA software validation guidance.
  • Engineering Specifications: Successful monitoring of H2O2 neutralization, accurate cycle indication via LED, proper device disablement after 65 cycles, material compatibility.
  • Predicate Device Equivalence: The performance of the legally marketed predicate device (Clear Care Contact Lens Case) forms a benchmark for "safe and effective."

8. The sample size for the training set

• Sample Size (Training Set): N/A. This is not an AI/machine learning device that uses a "training set."

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

• Ground Truth Establishment (Training Set): N/A. Not applicable.

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The icase™ Contact Lens Case is designed for storage of soft (hydrophilic) lenses during chemical disinfection.

Not Found

This document is a 510(k) clearance letter for a contact lens case, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth, or expert qualifications for AI/ML-based medical devices.

The document states that the "icase™ Contact Lens Case" is substantially equivalent to legally marketed predicate devices. This means that its safety and effectiveness were demonstrated by showing it is as safe and effective as a device already on the market, not through a study involving acceptance criteria and performance metrics as typically evaluated for AI/ML algorithms.

Here's why the requested information cannot be provided from this document:

1. Table of acceptance criteria and reported device performance: This document does not describe performance metrics or acceptance criteria for the contact lens case itself. Its clearance is based on substantial equivalence.
2. Sample size, data provenance: Not relevant for a substantial equivalence determination of a contact lens case. There's no "test set" in the context of an AI/ML study.
3. Number of experts, qualifications: Not relevant. The review is by FDA staff based on regulatory requirements.
4. Adjudication method: Not relevant.
5. MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted device.
6. Standalone performance: Not applicable.
7. Type of ground truth: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

In summary, the provided text is a regulatory clearance letter for a physical medical device (contact lens case) based on substantial equivalence to a predicate device, and it does not contain information related to the rigorous testing and validation processes typically associated with AI/ML-based medical devices.

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