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Intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Do not use during heat disinfection.

The contact lens cases are designed for storage of contact lenses. The Color Case Contact Lens Case has 2 adjoining wells that have screw top caps. The Flip N Slide Contact Lens Case model has 2 adjoining wells with integral hinged, self-sealing caps in which contact lenses are immersed. The devices are not sterile and are not for heat disinfection. They are made of polypropylene plastic. The volume capacity is 5.91 ml on each well of both lens cases.

This is not an AI software/device. No AI or Machine Learning algorithm is mentioned in the provided text. Therefore, the questions related to AI/ML device performance, training sets, test sets, and expert adjudication are not applicable.

The document describes a submission for contact lens cases (Color Case Contact Lens Case and Flip N Slide Contact Lens Case) which are physical devices used for storage of contact lenses during chemical disinfection.

Regarding the non-clinical testing performed for these physical devices:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly detailed in numerical values, but stated as "no leachable organic compounds above the pre-determined detection limit" for extraction testing and "met acceptance criteria" for biocompatibility testing.
   • Reported Device Performance:
     • Extraction Testing: "demonstrated there were no leachable organic compounds above the pre-determined detection limit."
     • Biocompatibility Testing: "has been conducted on the materials and met acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not provided in the document. The text only states that "Extraction testing was conducted" and "Biocompatibility testing has been conducted," without specifying sample sizes, data provenance, or study design (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as this is not an AI/ML device, and no "ground truth" in the context of expert review for diagnostic accuracy is being established. The testing appears to be laboratory-based analytical and biological testing.

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

   • Not applicable as this is not an AI/ML device and no human adjudication process for a test set is described.

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:

   • Not applicable. This is not an AI/ML device. "Clinical Testing" is explicitly stated as "Not Applicable".

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

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable in the context of AI/ML. For the non-clinical tests, the "ground truth" would be established by standard laboratory methods and control values for extraction and biocompatibility testing according to relevant ISO or ASTM standards, which are not detailed in this summary.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable. This is not an AI/ML device, so there is no training set or ground truth in this context.

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