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K Number
K021248
Device Name
ICASE
Manufacturer
IKEEPS, INC.
Date Cleared
2002-09-24

(158 days)

Product Code
LRX
Regulation Number
886.5928
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
Predicate For
K032309
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”