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Menicon Progent Large Diameter Contact Lens Case is only intended for use with the Menicon Progent Protein Remover for Rigid Gas Permeable (RGP) Contact Lenses.

The Menicon Progent Large Diameter Contact Lens Case provides an alternative lens case to hold large diameter lenses (11 mm to 23 mm) during the Menicon Progent Protein Remover treatment. The case is not intended for disinfection (chemical, heat or peroxide). The case is not intended for lens storage.

The Menicon Progent Large Diameter Contact Lens Case is a non-vented barrel style contact lens case. It consists of a clear polycarbonate (PC) cylinder with acrylonitrilebutadiene-styrene (ABS) copolymer non-vented screw cap and lens holder/basket. Each lens basket is molded with a letter, "L" or "R", for ease in proper lens identification. The left lens basket is also colored grey to assist patients who are not currently wearing their contact lenses. The lens case is capable of holding the 10 mL of Menicon Progent Protein Remover A/B mixed solution for effective protein removal.

The provided text describes a 510(k) premarket notification for a medical device (Menicon Progent Large Diameter Contact Lens Case) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, the submission details are focused on demonstrating substantial equivalence to predicate devices. This is a common pathway for Class II medical devices, where the manufacturer asserts that their new device is as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval.

Here's a breakdown of why this document doesn't fit the request and what it does contain:

Why the Request Cannot Be Fulfilled from this Document:

• No Acceptance Criteria: The document does not define specific performance metrics or thresholds (e.g., accuracy, sensitivity, specificity, or physical durability standards) for the Menicon Progent Large Diameter Contact Lens Case.
• No "Study" in the sense of performance evaluation: There isn't a study described that measures the device's performance against predefined criteria. Instead, it relies on a comparison of characteristics to predicate devices.
• Focus on Substantial Equivalence: The entire submission's purpose is to show that the new device is "substantially equivalent" to existing, legally marketed devices, rather than proving it meets novel acceptance criteria through new testing.

What the Document Does Provide (Relevant to the request in a broader sense):

1. A table of characteristics (not acceptance criteria):

   Characteristic	Menicon Progent Large Diameter Contact Lens Case (New Device)	Bonasse Barrel Style Lens Case (Predicate 1)	Progent SP Vial (Predicate 2)
   Manufacturer	Menicon Pharma	Bonasse Enterprise Company, Ltd.	Bonasse Enterprise Company, Ltd.
   Device Name	Contact Lens Case	Contact Lens Case	Contact Lens Case
   Model Name	Not Applicable	BC 790	BC 760-1
   Trade Name	Menicon Progent Large Diameter Contact Lens Case	Bonasse Barrel Style Lens Case BC 760-1	Barrel Style Lens Case
   Classification	Ophthalmic (Class II, LRX, 21 CFR 886.5918)	Ophthalmic (Class II, LRX, 21 CFR 886.5918)	Ophthalmic (Class II, LRX, 21 CFR 886.5918)
   Intended Use	For Storage of RGP Contact Lenses during lens treatment (protein removal), Not for use with heat, chemical or peroxide disinfection systems.	For Storage of soft, hard and RGP contact lenses during lens treatment (chemical disinfection), Not for use with heat or peroxide disinfection systems.	For Storage of RGP contact lenses during lens treatment (protein removal), Not for use with heat, chemical or peroxide disinfection systems.
   Materials	Clear Plastic Vial (PC), White Plastic screw top lid (ABS), White and Grey plastic lens baskets/holder (ABS)	Clear Plastic Vial, White Plastic screw top lid (ABS), White plastic lens baskets/holder (ABS)	Clear Plastic Vial, Green Plastic screw top lid, Clear plastic lens holder
   Volume	10 mL	10 mL	10 mL
   Biocompatibility	Components used in this lens case have been evaluated in accordance with Part 10993 of the ISO standard for Biological Evaluation. Test results indicate the test articles meet the ISO standard.	Biocompatibility testing by a third-party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.	Biocompatibility testing by a third-party laboratory demonstrated the materials are safe for use in contact lens storage and disinfection.

2. No sample size for test set / data provenance / experts / adjudication for this comparative study. The "study" here is a comparison of characteristics to established predicate devices, not a new performance study with a test set.

3. No MRMC comparative effectiveness study. This type of study (evaluating human reader improvement with AI) is irrelevant for this device, which is a physical contact lens case and not an AI-powered diagnostic tool.

4. No standalone performance evaluation. The submission relies on the established safety and effectiveness of the predicate devices and demonstrates that the new device's characteristics are similar enough.

5. Ground Truth Type: Not applicable in the context of this 510(k) submission. The ground truth for the predicate devices' safety and effectiveness was established through their own prior clearances and clinical use. For the new device, the "ground truth" is that its materials and design are comparable to those already deemed safe and effective.

6. Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

7. How ground truth for training set was established: Not applicable.

In summary, this document demonstrates that the Menicon Progent Large Diameter Contact Lens Case is substantially equivalent to predicate devices, primarily through a comparison of physical characteristics, materials, intended use, and general safety (biocompatibility). It does not present a de novo study with acceptance criteria and performance data for the device itself.

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