Search Results

Menicon Nect Contact Lens Case is indicated for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. This case is for use during chemical disinfection only. Not to be used with heat disinfection.

Device Description

The Menicon Nect Contact Lens Case consists of a molded dual compartment base unit and two screw caps. Both the base unit and screw caps are made from Polypropylene resin. The right screw cap is marked "R" and has a blue tint to assist patients who are not currently wearing their contact lenses. The lens compartments are of sufficient volume to allow contact lenses to be fully immersed during lens disinfection. The case is available in two models, one with ribs in the lens case wells and one without ribs in the lens case wells.

AI/ML Overview

The provided 510(k) summary for the Menicon Nect Contact Lens Case (K131875) does not describe an active device that utilizes AI or machine learning, and therefore, does not have conventional "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of diagnostic or predictive performance.

This submission is for a medical device (a contact lens case) that is seeking clearance based on substantial equivalence to a predicate device. The primary "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate device, primarily through material biocompatibility and functional equivalence.

Here's a breakdown based on the information provided, framed to address your questions as best as possible given the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are not performance metrics like sensitivity or specificity. Instead, they relate to compliance with standards and equivalence to the predicate.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Menicon Nect Contact Lens Case)
Biocompatibility: Safe for contact with the eye/lens.	Components evaluated in accordance with ISO 10993 Biological Evaluation of Medical Devices. Test results indicate components meet ISO standard (Cytotoxicity, Systemic Toxicity, Ocular Irritation).
Intended Use: Suitable for storage and chemical disinfection.	Indicated for storage during chemical disinfection of soft, rigid gas permeable, and hard contact lenses. Not for heat disinfection. (Same as predicate)
Material: Made from safe and suitable materials.	Polypropylene resin used for base and caps. (Same as predicate)
Design: Similar to predicate device, allowing proper immersion.	Molded dual compartment base, two screw caps (R marked, blue tint). Available with or without ribs. Similar in design to predicate.
Volume: Sufficient to immerse lenses.	3.6 mL. (Predicate: 3.8 mL; considered similar).
Disinfection Type: Chemical, not heat.	Chemical; Not Heat. (Same as predicate)
Sterilization: Not sold sterile.	Not Sold Sterile. (Same as predicate)
Overall Safety and Effectiveness: As safe and effective as predicate.	"Based upon the test data presented, the Menicon Nect Contact Lens Case is as safe, as effective and performs as well as the predicate device."

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

Test Set: Not applicable for a traditional "test set" in the context of an AI/ML device. For biocompatibility, general testing (Cytotoxicity, Systemic Toxicity, Ocular Irritation) was done on representative plastic components. The document does not specify the number of samples or animals used for these tests.
Data Provenance: The biocompatibility tests were conducted according to ISO 10993, which are international standards. The country of origin for the data is not explicitly stated but implies testing by a certified lab. The studies were likely prospective in nature (i.e., designed specifically for this submission).

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

Not applicable as this is not an AI/ML device requiring expert-established ground truth. Biocompatibility testing is typically performed by trained laboratory personnel following established protocols, and evaluation is against ISO standards.

4. Adjudication method for the test set:

Not applicable. Biocompatibility tests are objective measurements against defined pass/fail criteria from ISO standards, not subjective expert adjudication.

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-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

For biocompatibility: Ground truth is established by adherence to and passing criteria of ISO 10993 Biological Evaluation of Medical Devices standards.
For substantial equivalence: Ground truth is the predicate device (K121030 Sacks Holdings, Inc. Contact Lens Storage Case). The new device is compared feature-by-feature to the cleared predicate.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or associated ground truth establishment process for this type of device.

In summary: The submission demonstrates the Menicon Nect Contact Lens Case meets its "acceptance criteria" by showing it is substantially equivalent to a legally marketed predicate device (K121030) and that its materials are biocompatible according to international standards. Clinical studies were deemed unnecessary because the device's function is well-understood, and the lens care solutions used with it are already cleared.

Ask a Question

Ask a specific question about this device

Page 1 of 1