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The Etafilcon with Tangible Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The Etafilcon with Tangible Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism.

The Etafilcon with Tangible Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal.

The Etafilcon with Tangible Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is available in an aspheric design and manufactured using the cast-molding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are crosslinked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.

The Etafilcon with Tangible™ Coating (etafficon A) Soft (Hydrophilic) Daily Wear Contact Lenses are available in a light blue tint ([Phthalocyaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 mm), and less than 30% in the UVA range (316 to 380nm).

The Etafilcon with Tangible "M Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is treated to incorporate Tangible TM Coating Technology-which is a thin biocompatible polymer that is covalently bonded to the surface of the contact lens.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The lenses are supplied sterile in blister packages containing a buffered saline solution. Package 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 "Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens." It asserts substantial equivalence to predicate devices and describes the non-clinical and previous clinical performance testing. However, it does not contain specific acceptance criteria with reported device performance in a table format for a diagnostic device. Since this is an approval for a contact lens, the nature of the "acceptance criteria" and "device performance" differ significantly from what would be expected for a diagnostic AI/ML device.

Based on the provided text, here's an attempt to answer the questions, focusing on the information available regarding the contact lens rather than an AI/ML diagnostic system:

1. A table of acceptance criteria and the reported device performance

   The document does not present acceptance criteria or reported device performance for an AI/ML diagnostic in a table. Instead, it describes general safety and performance characteristics for a contact lens. The "performance" for this device relates to its physical properties and biocompatibility.

   Acceptance Criteria (Implied from the document goals)	Reported Device Performance (from the "Testing" section)
   Lenses are sterile for the indicated shelf-life.	Confirmed: "Lenses supplied in blister packages are sterile for the indicated shelf-life."
   Finished lenses, packaging material, and extracts are non-toxic and non-irritating.	Confirmed: "The finished lenses, packaging material and extracts are non-toxic and non-irritating." (Based on in vitro and in vivo preclinical toxicology and biocompatibility tests)
   Lens physical and material properties are consistent with currently marketed lenses.	Confirmed: "Lens physical and material properties are consistent with currently marketed lenses." (Based on non-clinical testing)
   Safe and effective for indicated use when compared to predicate devices.	Confirmed: "The Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is as safe and effective as the predicate device..."
   Clinical performance has been established.	Confirmed: "The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing."
   Physical properties (Water Content, Oxygen Permeability, Specific Gravity, etc.)	Water Content: 58 ±2%

Oxygen Permeability: 24.1 x 10-11 (cm²/sec)(ml O2/ml-mmHg)
Specific Gravity: 1.14 (hydrated)
Refractive Index (wet): 1.404
Visible Light Transmission: >90% |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document mentions "a series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed." It also states, "The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing." However, specific sample sizes for these tests (whether animal or human subjects for the "clinical performance testing") are not provided. The data provenance (country, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This information is not applicable and not provided in the document as it pertains to a contact lens, not an AI/ML diagnostic system requiring expert-adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device with a test set requiring 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

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device.

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

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device. The device itself is the contact lens, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   For the contact lens, the "ground truth" for safety and effectiveness appears to be established through:

   • Biocompatibility and toxicology studies (in vitro and in vivo) to confirm non-toxicity and non-irritation.
   • Sterility testing to confirm shelf-life.
   • Physical and material property measurements compared against known acceptable ranges for contact lenses.
   • Previous clinical performance testing of the etafilcon A material.

8. The sample size for the training set

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device that requires a training set.

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

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device that requires a training set.

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The Optimum GP with HPT (roflufocon C, D, and E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The Optimum GP with HPT (roflufocon C, D, and E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only

The Optimum GP with HPT (roflufocon C, D, and E) Irregular Cornea Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Optimum GP with HPT (roflufocon C. D. and E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The Optimum GP with HPT (roflufocon C, D, and E) 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 (roflufocon C, D, and E) 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 30mm in thickness.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens are packaged and shipped "wet" in a polypropylene contact lens case. The primary container for shipping the Optimum GP with HPT lenses is the PolyVial Contact Lens Case. The Optimum GP with HPT lenses are packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

In the Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380mm.

The Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:

• 7.0mm to 22.0mm Chord Diameter: ●
• Center Thickness: Varies
• Base Curve:
• Spherical Powers:
• Toric Powers:
• Add Powers: ●

5.0mm to 8.0mm -20.00 Diopters to +20.00 Diopters up to -10.00 Diopters

• up to +4.00 Diopters

The document describes the K161100 submission for the "Optimum GP with HPT (roflufocon C, D, and E) Daily Wear Contact Lenses." The purpose of this 510(k) submission is to introduce new technology to existing contact lenses by including Hydra-PEG Technology (HPT) to improve wettability.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion and performance metric highlighted is improved wettability, specifically measured by the captive bubble dynamic contact angle. The document compares the new HPT-coated lenses to the uncoated predicate lenses.

Interpretation: The HPT-coated lenses demonstrate a significant reduction in the average captive bubble dynamic contact angle across all three roflufocon materials (C, D, and E), indicating improved wettability as intended.

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

• Test Set Sample Size for Wettability: For the wettability measurement (contact angle), the sample size was n=3 for each material (roflufocon C, D, and E), for both uncoated and HPT-coated lenses.
• Data Provenance: The document does not explicitly state the country of origin for the wettability data. It is an in-vitro study, comparing the physical properties of the lenses. The general statement "Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability studies following scientific protocols" suggests a controlled laboratory environment. The provided information does not indicate if it's retrospective or prospective, but due to its nature as a controlled lab test, it would be considered prospective for the specific test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The wettability test (captive bubble dynamic contact angle) is an objective physical measurement performed in a laboratory, not a subjective assessment requiring human experts to establish "ground truth" in the way clinical diagnosis or image interpretation would. Therefore, the concept of "experts" as described in the prompt is not applicable to this specific performance criterion.

4. Adjudication Method for the Test Set

Since the wettability test is a direct physical measurement, it does not involve human adjudication for establishing ground truth. The measurement is taken by instrumentation, and the results are quantitative. Therefore, no adjudication method (e.g., 2+1, 3+1) was used or is relevant for this specific test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this device. The submission focuses on the chemical and physical properties of the contact lens material and its surface coating, not on diagnostic performance or human-in-the-loop clinical effectiveness related to AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This device is a medical device (contact lens), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance measured is that of the physical device itself.

7. Type of Ground Truth Used

For the wettability performance, the "ground truth" is established by direct physical measurement using standardized laboratory methods (specifically, the captive bubble dynamic contact angle). This is an objective measurement of a material property rather than a subjective clinical assessment or pathology result.

8. Sample Size for the Training Set

This submission addresses a medical device (contact lens) and its material properties, not an AI or machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The testing performed is to characterize the physical properties of the device.

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

As stated above, this is not an AI/ML development, so the concept of a "training set" and its "ground truth" establishment is not applicable.

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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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