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The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable (silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.

The NoveLens® Contact Lens Case is a contact Iens storage case comprised of a plastic case that houses two chambers. The upper chamber which holds the lenses separately in individually attached concave reservoirs and a lower chamber that provides space for rinsed solution as it passes through holes from the upper chamber and through a drainage toube into the lower portion of the device. The NoveLens® Contact Lens Case is constructed to take solution introduced into the upper chamber in a rinse fashion and force, by gravity, solution through the drainage holes through a drainage tube and into a lower collecting chamber. Additional solution is added until both chambers are completely filled to the top. Screw caps when closed hermetically seal the system to hold disinfection solution while the lenses are stored and disinfected in accordance with directions consistent with labeled multipurpose contact lens solutions. The design provides for one-way ingress of solution and expulsion of spent solution through external drainage holes from the lower chamber upon tipping the unit on its side.

Here's a breakdown of the acceptance criteria and study information for the NoveLens® Contact Lens Case, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for the toxicology tests.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted on the plastic components of the NoveLens® Contact Lens Case. It is retrospective in the sense that the materials were tested prior to submission for clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable in the context of toxicology testing; the "ground truth" is determined by established scientific methods and regulatory guidance for chemical safety. Expertise would be in toxicology and materials science, but specific numbers and qualifications are not provided for reviewers of the toxicology test results beyond FDA.

4. Adjudication Method for the Test Set

• Not applicable. Toxicology testing results are typically evaluated against pre-defined thresholds and regulatory guidelines rather than through expert adjudication of individual cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This device is a contact lens case, not an imaging or diagnostic AI device that would typically involve human readers.

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

• Not applicable. This is a physical medical device (contact lens case), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the toxicity testing, the "ground truth" was established by standardized laboratory testing procedures and accepted regulatory guidance (FDA Guidance for contact lens case products; Guidance for Industry-Premarket Notification 510(k) Guidance Document for Contact Lens Care Products- dated May 1, 1997, and ISO-10993-1).
• For effectiveness, the ground truth was demonstrated by substantial equivalence to predicate devices without additional effectiveness testing.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable as there is no training set for this type of device.

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