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The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are lathe cut from one of the following hydrophobic. FDA Group #3 fluoro-silicone acrylate materials: hexafocon A, hexafocon B, or oprifocon A-with the following properties: Refractive Index, Water Content, Specific Gravity, Wetting Angle, Oxygen Permeability (Dk) ISO/FATT Method (cm2/sec) (ml O2/ml x mm Hg @ 35°C), Contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power, Aspheric Lens Eccentricity.

This document is a 510(k) Premarket Notification for the eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K.

The provided text does not describe a study that uses AI or machine learning models to meet acceptance criteria, but rather focuses on substantial equivalence to existing predicate devices for rigid gas permeable contact lenses. Therefore, I cannot extract information related to AI/ML model acceptance criteria, performance, sample sizes for test/training sets, expert adjudication, or MRMC studies from this document.

The document primarily covers:

• Device Description: Materials, properties, and available parameters of the contact lenses.
• Intended Use/Indications for Use: Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia), management of irregular corneal conditions, and temporary reduction of myopia for Ortho-K.
• Predicate Devices: Lists several "Boston" brand contact lenses as predicate devices.
• Substantial Equivalence: Argues that the eLens is substantially equivalent to the predicate devices based on common classification, product code, FDA Group #, USAN, production method (lathe-cut), actions, intended use, and indications for use.
• Performance Data: States that non-clinical and clinical performance data have been addressed by reference to the predicate devices and in previous applications.

Therefore, I cannot fulfill the request to discuss acceptance criteria and study proving the device meets those criteria, as the document does not contain information about an AI/ML-based study.

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