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The Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism.

The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism.

The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism.

The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism.

The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.

The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a hydrophilic contact lens which is available as a spherical/aspherical, toric, multifocal and multifocal toric lens. This soft contact lens is indicated for daily wear frequent replacement.

The non-ionic lens material (asmofilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 60% asmofilcon A and 40% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint, C.I. Reactive Blue 246.

The hydrophilic material characteristics allow aqueous solutions to enter the lens. In its fully hydrated state, the lens is approximately 40% water by weight.

The provided document is a 510(k) premarket notification for a soft contact lens and does not describe an AI medical device. Therefore, it does not contain the specific information required to answer the questions about AI device acceptance criteria, study design, expert involvement, or ground truth establishment.

The document focuses on demonstrating substantial equivalence to a predicate device for a new contact lens product, the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens.

Here's a breakdown of why the requested information for an AI/device study cannot be extracted from this document:

• No AI Component: The device is a physical contact lens, not an algorithm or software that processes medical images or data.
• Acceptance Criteria: The document assesses the contact lens's physical properties, safety, and efficacy through non-clinical and clinical studies, but these are not "acceptance criteria" for an AI model's performance metrics (e.g., sensitivity, specificity, AUC).
• Study Design: The clinical study described is a 3-month trial comparing the new lens to a control lens in subjects, focusing on biomicroscopy, adverse events, visual acuity, wearing times, and comfort. This is a standard clinical trial design for a medical device, not an AI performance study.
• Ground Truth/Experts/Adjudication: These concepts are central to validating AI models where human expert labels or definitive diagnoses are used as "ground truth." For a contact lens, the "ground truth" relates to clinical outcomes in patients, not expert review of images.
• MRMC Study/Standalone Performance: These are specific types of studies for AI algorithms (Multi-Reader Multi-Case for human-AI interaction, standalone for algorithm-only performance). They are irrelevant for a physical contact lens.
• Training Set/Ground Truth Establishment for Training: These concepts apply to the development and validation of machine learning models. A contact lens does not have a "training set" in this sense.

In summary, this document is appropriate for a medical device submission (contact lens) but does not provide the information requested for an AI medical device.

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