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The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eves with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, non-diseased eyes with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eyes with astigmatism or irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using only a chemical (not heat) disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

The SynergEves® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens-at the central optical portion of the lens corresponding to the cornea-and soft hydrophilic silicone-hydrogel skirt-straddling the limbus of the eye peripherally. The lenses are manufactured by lathe cutting process for custom Rx, and fabricated from petrafocon A (rigid, central portion) and hem-larafilcon A (soft, peripheral portion). The soft skirt is comprised of silicone hydrogel copolymer (hem-larafilcon A). The lens consists of 28% water and 72% (petrafocon A and hem-larafilcon A). The (petratocon A and hem-larafilcon A) names have been adopted by the United States Adopted Names Council (USAN). When placed on the human cornea, the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens acts as a refractive medium to focus light rays onto the retina.

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens incorporates a violet visibility tint in the rigid gas permeable center, and a UV absorber. The device is available in the spherical, aspheric, multifocal (progressive), post-surgical, & irregular cornea design configurations with the following properties:
• Chord Diameter 13.0 mm to 25.00 mm
• Center Thickness 0.050 mm to 0.500 mm
• Base Curve 5.50 mm to 9.50 mm
• Power Range (sphere) -25.00D to +25.00D
• Add Power +1.00D to +4.00D

The Physical properties of the lens are:
Refractive Index (wet) RGP Center 1.442 Soft Skirt 1.435
Luminous Transmittance (tinted) (380nm to 780) 87% 97%
Surface Character hydrophobic hydrophilic
Water Content 28 ± 2%
Specific Gravity 1.15 N/A
Oxygen Permeability (revised Fatt method) 130 84

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (petrafocon A hem-larafilcon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

This document describes the premarket notification (510(k)) for the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens. The core of the submission revolves around demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the data and analyses presented to the FDA to establish this substantial equivalence, particularly focusing on how the new Hydra-PEG technology impacts the lens properties.

The document does not describe a traditional AI/ML model's acceptance criteria or performance study in the way one might evaluate a diagnostic algorithm. Instead, it focuses on the physical and chemical properties of a medical device (contact lens) and its clinical safety and effectiveness through comparisons to existing devices.

Here's an interpretation based on the provided text for the requested information, understanding that "acceptance criteria" here relates to demonstrating comparable performance and safety, primarily in terms of wettability improvement:

Overview of Device and Purpose of Submission:

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a modification of existing SynergEyes® SiH lenses to include Hydra-PEG Technology (HPT). HPT is a polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. The submission aims to demonstrate that this modification does not change the design or indications for use, and that the lens with HPT is substantially equivalent to the predicate devices while offering improved wettability.

1. Table of Acceptance Criteria and Reported Device Performance

For a contact lens, acceptance criteria for physical properties typically involve demonstrating that the new device performs at least as well as, or better than, the predicate device in key safety and performance metrics. The primary criterion highlighted for the new technology (Hydra-PEG) in this submission is improved wettability.

Note on "Acceptance Criteria": This document primarily focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. For the Hydra-PEG modification, the key "acceptance" is that it improves wettability without negatively impacting other critical safety and performance parameters, and that its overall safety and efficacy are maintained as per the predicate device.

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

• Sample Size for Wettability Test: n = 20 lenses (for the statistical comparison of mean contact angle between coated and uncoated lenses).
• Data Provenance: Not explicitly stated regarding country of origin or specific study sites. The non-clinical toxicology and biocompatibility tests were conducted "in vitro and in vivo" and "in accordance with the GLP regulation." The clinical safety and effectiveness were "previously established" for the base hybrid contact lenses and for contact lenses treated with Hydra-PEG, suggesting reliance on existing data rather than a new, dedicated clinical trial for this specific 510(k) submission. Therefore, it's retrospective in the sense of leveraging prior data, but the wettability test itself was likely a specific laboratory test for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission is for a medical device (contact lens), not an AI/ML diagnostic system. Therefore, the concept of "experts establishing ground truth" in the diagnostic image interpretation sense does not apply directly. The "ground truth" for device performance is based on quantifiable physical properties (e.g., contact angle, water content, oxygen permeability) measured through validated laboratory methods, and clinical safety and efficacy data from previous studies.

4. Adjudication Method for the Test Set

Not applicable in the context of device physical property testing or clinical safety and efficacy data for a contact lens. Adjudication methods are relevant for subjective interpretations of data, particularly in medical image analysis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This was not done. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for medical imaging) to assess reader performance with and without AI assistance. This submission is for a therapeutic device (contact lens) where the primary mechanism of action is physical correction of vision and surface properties, not diagnostic interpretation.

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

Not applicable. This is not an algorithm, but a physical medical device. The "standalone performance" refers to the intrinsic performance of the lens itself (e.g., wettability, refractive correction, safety profile).

7. The Type of Ground Truth Used

The "ground truth" (or basis for claiming safety and effectiveness and substantial equivalence) for this device includes:

• Quantitative Physical Property Measurements: Laboratory measurements of properties like contact angle (wettability), refractive index, luminous transmittance, water content, specific gravity, and oxygen permeability. These are objective, measurable parameters.
• Non-clinical Toxicology and Biocompatibility Data: Results from in vitro and in vivo tests confirming the safety of the materials and the finished lens, in accordance with GLP regulations.
• Clinical Safety and Effectiveness Data (Referenced): "[T]he clinical safety and effectiveness has been previously established for hybrid contact lenses manufactured from (petrafocon A hem-larafilcon A) and contact lenses treated with Hydra-PEG." This implies reliance on existing clinical data for the base material and the Hydra-PEG technology itself, rather than a new, dedicated clinical trial for this specific lens permutation.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML model that requires a "training set." The development of the Hydra-PEG technology and the contact lens material would involve R&D and optimization, but not in the sense of an AI model's training data.

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

Not applicable, as it's not an AI/ML model.

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