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510(k) Data Aggregation
(158 days)
The icase™ Contact Lens Case is designed for storage of soft (hydrophilic) lenses during chemical disinfection.
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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:
- 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.
- 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.
- Number of experts, qualifications: Not relevant. The review is by FDA staff based on regulatory requirements.
- Adjudication method: Not relevant.
- MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted device.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- 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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