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The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.

The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not 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 Optimum Infinite (tisilfocon A) 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.

The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are 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. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.

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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process. In the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280mm - 315nm) and >85% in the UVA range (316 - 380nm). The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate 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, D&C Violet No. 2 and D&C Red No. 17. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations.

The provided text describes a 510(k) premarket notification for the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses, which doesn't typically follow the same acceptance criteria and study structure as an AI/ML device. Therefore, the specific questions regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not directly applicable in the conventional sense for this type of device submission.

However, I can extract information related to the device's performance, clinical studies conducted, and the basis for its safety and effectiveness.

Here's an adaptation of the request based on the provided text, focusing on the information available:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a contact lens, the "acceptance criteria" are generally based on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through non-clinical and clinical data. Specific quantitative "acceptance criteria" and "device performance" metrics of an AI/ML device (e.g., sensitivity, specificity thresholds) are not present. Instead, the performance is demonstrated by the absence of serious adverse events and positive clinical outcomes.

2. Sample size used for the test set and the data provenance:

• Sample Size (Clinical Study): 62 patients (115 total eyes) were evaluated in the clinical study for therapeutic use of scleral lenses.
  • 55 eyes for irregular cornea management.
  • 62 eyes for ocular surface disease management.
• Data Provenance: The text does not explicitly state the country of origin of the data. The study appears to be prospective in nature, as practitioners were "instructed to review all patients treated... and to report the outcome." The study followed patients for "at least 3 months" over a "treatment follow-up period."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Six (6) independent practitioners.
• Qualifications of Experts: The specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond "independent practitioners." For contact lens studies, these would typically be ophthalmologists or optometrists experienced in fitting and managing contact lens patients, particularly those with complex conditions like irregular corneas or ocular surface diseases.

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

• The text does not mention an explicit adjudication method. The independent practitioners reported outcomes, and the overall clinical assessment ("remained stable or improved") was the basis for the conclusion. There's no indication of multiple readers adjudicating cases in the manner described for AI/ML studies.

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:

• No, an MRMC comparative effectiveness study involving AI assistance was not conducted. This is a medical device (contact lens) submission, not an AI/ML diagnostic or assistive device.

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

• No, a standalone algorithm performance study was not done. This device is a contact lens and does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the clinical diagnosis and assessment of therapeutic outcomes by the independent practitioners based on objective and subjective patient data (e.g., vision improvement, stability of ocular conditions, absence of adverse events). It's essentially expert clinical assessment/outcomes data.

8. The sample size for the training set:

• This is not applicable as this is not an AI/ML device that requires a training set in that context. The device's safety and effectiveness are established through non-clinical testing and clinical studies on its material properties and patient outcomes, not through learning from data.

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

• Not applicable for the reason stated above.

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The Hyper GP (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.

The Hyper GP (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Hyper GP (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves 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 Hyper GP (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eves 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.

The Hyper GP (tisilfocon A) ORTHOKERATOLOGY contact lenses are 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. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.

In the Hyper GP (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280nm = 315nm) and >85% in the UVA range (316 - 380nm).

The Hyper GP (tisilfocon A) 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, D&C Violet No. 2 and D&C Red No. 17.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens is available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters: Base Curve, Center Thickness, Chord Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters: Base Curve (BC), Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power.

The Hyper GP (tisilfocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the Hyper GP (tisilfocon A) Daily Wear Contact Lens is the Poly Vial Contact Lens Case. When shipped "wet", the Hyper GP (tisilfocon A) Daily Wear Contact Lens may be 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%.

This document describes the Hyper GP (tisilfocon A) Daily Wear Contact Lens and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and a detailed analysis of device performance against those criteria as would be found in a typical AI/ML medical device submission.

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" are related to a comparison of technical characteristics and the successful completion of non-clinical and clinical studies for a contact lens.

Here's an interpretation of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the typical format of quantitative thresholds for a specific study. Instead, it demonstrates acceptance primarily through substantial equivalence to predicate devices and through a series of non-clinical (in vitro and in vivo toxicology/biocompatibility) and clinical studies. The reported device performance is presented as meeting safety and effectiveness expectations, aligning with previously established performance for similar materials and designs.

The key "performance data" highlights can be interpreted as demonstrating the device meets the implied acceptance criteria for a contact lens, specifically in terms of material properties, safety, and physical compatibility.

Table of "Acceptance Criteria" (Implied) and "Reported Device Performance":

Additional Requested Information:

Since this document is a 510(k) summary for a contact lens, it details substantial equivalence to predicates rather than presenting a performance study with specific AI/ML metrics, test sets, or ground truth establishment methods typically associated with AI-driven devices. Therefore, many of the requested points below are not applicable or explicitly stated in this type of submission.

1. Sample size used for the test set and the data provenance:

   • Test Set (Non-Clinical):
     • For Average Sessile Drop Contact Angle: n=30 lenses were tested for both uncoated and Tangible™ Hydra-PEG coated lenses.
     • For Bioburden levels: Not explicitly stated, but tests were conducted.
     • For Stability of physical parameters: Not explicitly stated, but tests were conducted.
     • Data Provenance: Not specified, but likely from in-house or contracted laboratory testing as part of the regulatory submission process.
   • Test Set (Clinical): The document states that "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from tisilfocon A has been previously addressed." This implies that new clinical trials were not conducted for this specific 510(k) submission, but rather referenced existing data for the material. Therefore, no new sample size or provenance for a new clinical test set is provided here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and submission. "Ground truth" in this context refers to standard measurements, not expert annotations of images or other data. Non-clinical tests follow established protocols and standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Standardized laboratory testing methods were used, not expert adjudication panels.

4. 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: Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a contact lens.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For non-clinical tests (e.g., Dk, contact angle, toxicity, bioburden), the "ground truth" is defined by established physical, chemical, and biological testing standards and measurements.
   • For clinical performance, it refers to previously collected outcomes data and clinical experience with the tisilfocon A material, which established its safety and effectiveness.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

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

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The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses.

The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

The provided text describes a 510(k) summary for a contact lens insertion solution called Nutrifill. It outlines the device's characteristics and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of a medical imaging or AI device.

The "Performance Data" section explicitly states:

• Non-Clinical Studies: "A series of studies were completed to demonstrate the substantial equivalence of the Nutrifill preservative free insertion solution to the predicate device. Results of non-clinical testing demonstrate:
  • The Nutrifill solution is non-toxic and non-irritating
  • The final packaging is non-toxic and non-irritating"
• Clinical Studies: "Clinical studies involving the Nutrifill solution were unnecessary for this application. Lens care solutions used with this Nutrifill solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this information is not present in the given document. The submission focuses on demonstrating substantial equivalence to predicate devices for a contact lens care product, rather than reporting performance against specific acceptance criteria for a diagnostic or AI-driven device.

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OPTIMUM GP (roflufocon D. roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. OPTIMUM GP (roflufocon D) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error.

The lenses may be disinfected using a chemical disinfection (not heat) system only.

The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, or hexafocon A-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Water Content, Specific Gravity, Shore D Hardness, Oxygen Permeability (Dk) ISO/FATT Method, Contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D, UV Light Blocking (UVB - 280nm – 315nm; UVA 316nm – 380nm). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available with or without Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability compared to untreated lenses. The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the lenses may be 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 (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.

This document is a 510(k) premarket notification for Contamac, Ltd.'s OPTIMUM GP and HEXA100 Daily Wear Contact Lenses. It seeks to demonstrate substantial equivalence to a predicate device and expand the indications for use to include therapeutic applications.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantified, pass/fail manner for the device's therapeutic indication. Instead, it relies on demonstrating substantial equivalence to a predicate device and referencing previously established safety and effectiveness.

The comparison is primarily based on:

• Material properties: Refractive Index, Light Transmission, Water Content, Specific Gravity, Shore D Hardness, Oxygen Permeability (Dk), Color additives, UV Light Blocking.
• General characteristics: Intended use, indications for use, actions, classification, FDA material group, production method.
• Surface treatment: The new device offers Tangible™ Hydra-PEG surfacing, which the predicate did not. This is presented as an improvement in wettability.

Therefore, the "acceptance criteria" appear to be implicit: the device's materials and characteristics must be comparable to or better than the predicate, and its therapeutic indications must be sufficiently similar to those previously cleared.

2. Sample size used for the test set and the data provenance:

The document states:

• "Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D. roflufocon E, and hexafocon A materials has been addressed in previous applications."
• "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, and hexafocon A has been previously addressed."

This indicates that no new specific clinical or non-clinical test sets were conducted or analyzed for this specific 510(k) submission. The submission relies on existing data from previous applications for the same materials. Therefore, the sample sizes and data provenance for these "previously addressed" studies are not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set for which ground truth would need to be established by experts is described in this submission. The submission references previously conducted studies.

4. Adjudication method for the test set:

Not applicable. No new test set is described.

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:

Not applicable. This is a contact lens device, not an AI diagnostic imaging device.

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

Not applicable. This is a contact lens device, not an AI algorithm.

7. The type of ground truth used:

For the material properties, the "ground truth" would be established through laboratory testing according to recognized standards (e.g., ISO/FATT Method for Oxygen Permeability).

For the safety and effectiveness mentioned as "previously addressed," the ground truth would likely have involved:

• Clinical outcomes data: Patient visual acuity, comfort, adverse event rates, fit evaluations, etc., from clinical trials.
• Expert clinical assessment: Evaluation by ophthalmologists or optometrists.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

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The ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) 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 ENFLU 18 (enflufocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise nondiseased 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.

Eye care 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 ENFLU 18 (enflufocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoroitaconate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

In the ENFLU 18 (enflufocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for ENFLU 18 averages > 98% in the UVB range of 280nm - 315nm and >83% in the UVA range of 316 - 380mm.

The ENFLU 18 (enflufocon A) 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, D&C Violet No. 2 and D&C red No. 17.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "M Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (enflufocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

The ENFLU 18 (enflufocon A) Daily Wear Contact Lens may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the ENFLU 18 (enflufocon A) Daily Wear Contact Lenses may be 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 provided document describes the ENFLU 18 (enflufocon A) Daily Wear Contact Lens, a rigid gas permeable (RGP) contact lens, and its substantial equivalence to predicate devices, thus demonstrating its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the ENFLU 18 device in the format of a pre-defined threshold vs. actual performance data. Instead, it demonstrates substantial equivalence by comparing the ENFLU 18's physical properties and performance characteristics to those of predicate devices. The "reported device performance" are the physical properties listed for ENFLU 18. The "acceptance criteria" are implied by the properties of the predicate devices for which the new device is deemed substantially equivalent.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Wettability Testing: 30 lenses (n=30) were used for the sessile drop contact angle measurements for both uncoated and Tangible™ Hydra-PEG coated ENFLU 18 lenses.
• Data Provenance: The document states that "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed". It also mentions that "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." This implies a controlled laboratory setting. The country of origin for the data is not explicitly stated. The study is described as "preclinical" and "in vitro and in vivo," indicating a mix of laboratory and potentially animal or human (for biocompatibility) testing. The document also states "The clinical safety and effectiveness has been previously established for contact lenses manufactured from (enflufocon A) and contact lenses treated with Tangible ™ Hydra-PEG," indicating that the clinical data for these materials are retrospective from prior research.

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

This information is not provided in the document. The studies mentioned are primarily technical and laboratory-based, focusing on material properties, toxicology, and biocompatibility, rather than diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are not based on subjective interpretation or a diagnostic assessment requiring adjudication. They focus on objective measurements of physical, chemical, and biological properties.

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

A MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device (contact lens) and its substantial equivalence submission. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed, nor is it applicable. The device is an RGP contact lens, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests described were:

• Objective measurements: For physical properties like refractive index, light transmission, specific gravity, oxygen permeability, and wettability (sessile drop contact angle).
• Established scientific protocols/standards: For toxicology, biocompatibility, and microbiological testing (e.g., GLP regulations, bioburden acceptance criteria).
• Predicate device characteristics: The acceptance that the ENFLU 18 is substantially equivalent relies on its properties being comparable to those of the legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not applicable as the document describes the testing of a medical device (contact lens), not the development of an artificial intelligence or machine learning model that requires a training set.

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

This information is not applicable for the same reason as #8.

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The HEXA100 (hexafocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.

The HEXA100 (hexafocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The HEXA100 (hexafocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not 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 HEXA100 (hexafocon A) 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.

The HEXA100 (hexafocon A) ORTHOKERATOLOGY contact lenses are 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. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The HEXA100 (hexafocon A) Daily Wear Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

In the HEXA100 (hexafocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV blocking for HEXA100 averages > 98% in the UVB range of 280nm - 315nm and >84% in the UVA range of 316 - 380nm.

The HEXA100 (hexafocon A) 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, D&C Violet No. 2 and D&C Red No. 17.

The HEXA100 (hexafocon A) Daily Wear Contact Lens may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in nondiseased eyes.

The HEXA100 (hexafocon A) Daily Wear Contact Lens may be optionally treated to incorporate Tangible "10 Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible 10 Hydra-PEG, the underlying material (hexafocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness.

The HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the HEXA100 (hexafocon A) Daily Wear Contact Lenses may be 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 HEXA100 (hexafocon A) Daily Wear Contact Lens is available in the Spherical. Toric. Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations, within the following lens parameters:
• Chord Diameter: 7.0mm to 22.0mm

• Center Thickness: Varies
• Base Curve: 5.0mm to 8.0mm
• Spherical Powers: -20.00 Diopters to +20.00 Diopters
• Toric Powers: up to -10.00 Diopters
• Add Powers: up to +4.00 Diopters

The HEXA100 (hexafocon A) Daily Wear Contact Lens for daily wear orthokeratology is available in following lens parameters:
● Chord Diameter: 6.5 to 11.5 mm
● Center Thickness: 0.10 to 0.70 mm

• Base Curve (BC): 6.5 to 11.0 mm
  ● Secondary Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
  ● Peripheral Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
• Spherical Powers: -10.00 to +3.00 D

Acceptance Criteria and Device Performance for HEXA100 (hexafocon A) Daily Wear Contact Lens

This submission establishes substantial equivalence for the HEXA100 (hexafocon A) Daily Wear Contact Lens by comparing its performance to predicate devices. The acceptance criteria are essentially demonstrated equivalence to these established devices through physical, chemical, and biological testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates performance equivalent or superior to predicate devices across various physical and chemical properties and biocompatibility. The acceptance criteria for the HEXA100 (hexafocon A) Daily Wear Contact Lens are implicitly set by the performance characteristics of its predicate devices and internal validation for safety and stability.

2. Sample Size for Test Set and Data Provenance

The provided document does not explicitly state a sample size for a "test set" in the context of clinical trials as it relies heavily on non-clinical testing and established clinical safety of the material and coating.

• Non-clinical Testing: Conducted "in vitro and in vivo" for toxicology and biocompatibility. All toxicology tests were conducted in accordance with GLP regulations.
• Wettability Data (Sessile Drop Contact Angle): The table indicates "n=30" for the average sessile drop contact angle measurements.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data. It also does not specify whether the data is retrospective or prospective, although GLP (Good Laboratory Practice) regulations generally imply prospective and controlled studies for toxicology.

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

The concept of "experts" establishing ground truth as typically understood in AI/imaging studies (e.g., radiologists) is not applicable here. This submission focuses on the material's physical, chemical, and biological properties, and its substantial equivalence to predicate contact lenses. The "ground truth" for these tests is established by scientific methodologies and accepted standards (e.g., ISO for Dk, GLP for toxicology).

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are not applicable here. These methods are typically used in clinical studies where human interpretation of medical images or patient outcomes requires consensus among multiple experts. The testing performed for this device involved laboratory measurements and analyses of material properties and biological responses, not subjective interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not performed, nor is it applicable for this device. Such studies are typically conducted for AI-assisted diagnostic devices where the interaction between human readers (e.g., radiologists) and AI algorithms is being evaluated for improved diagnostic accuracy or efficiency. The HEXA100 contact lens is a passive medical device, not an AI diagnostic tool.

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

A standalone algorithm-only performance study was not performed, nor is it applicable. This device is a contact lens, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Scientific and Engineering Standards: Measurements of physical properties (e.g., refractive index, specific gravity, oxygen permeability) and chemical properties.
• Biological Standards: Results from in vitro and in vivo biocompatibility and toxicology tests, often governed by ISO standards (e.g., ISO 10993 for biological evaluation of medical devices).
• Predicate Device Performance: The established safety and effectiveness profiles of legally marketed predicate devices serve as the benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set

A "training set" is not applicable for this device. This is not a machine learning or AI device that requires a training set. The manufacturing process of contact lenses (lathe-cut, custom manufactured) and the material properties are characterized through traditional scientific and engineering methods.

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

As there is no training set, this question is not applicable.

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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 OPTIMUM GP OK contact lenses are 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. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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 OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) 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 OK Daily Wear Contact Lens (roflufocon D & E) 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 – 380nm.

The provided text is a 510(k) summary for the OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens. It does not describe a study that uses acceptance criteria in the manner typically associated with AI/ML device performance evaluations. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed clinical or technical study with specific performance metrics and acceptance thresholds for a novel device function.

Therefore, many of the requested fields cannot be directly extracted or are not applicable from this type of regulatory document.

However, I can extract information related to product specifications and a comparison to predicate devices, which serve a similar purpose in demonstrating that the new device is "as good as" existing, cleared devices.

Here's an attempt to answer the questions based on the provided text, while noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the context of a statistical study with performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic test. Instead, it demonstrates substantial equivalence by comparing the physical and chemical properties and indications for use of the proposed device to legally marketed predicate devices. The "performance" here is that its characteristics are similar enough to existing devices to not raise new questions of safety and effectiveness.

Here's a table comparing key characteristics of the subject device with its predicates, as presented in the document:

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

The document refers to demonstrating "safety" through K033594, which itself encompasses "Clinical Performance" for the material (roflufocon D & E). However, this document does not describe a new clinical study. It leverages prior clearance of the material and the intended use.
Therefore, there is no explicit "test set" sample size or data provenance mentioned for a new study within this 510(k) submission.

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)

Not applicable. This is not a study requiring expert-established ground truth for a test set.

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

Not applicable. There is no test set or adjudication method described.

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

Not applicable. This device is a contact lens, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This device is a contact lens, not an algorithm.

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

Not applicable. The clearance is based on substantial equivalence to predicate devices, not on a new study requiring a defined ground truth. Previous clearances (K033594 for material safety, K973697 and K071266 for orthokeratology indication and design) would have involved their own safety and effectiveness data, likely including outcomes data from clinical trials for contact lenses (e.g., visual acuity, corneal health, adverse events) to support their original clearance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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The OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes, The lenses may be disinfected using a chemical disinfection system only.

OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Daily Wear Contact Lenses.

This letter is a medical device approval from the FDA, and as such, it does not contain the detailed technical study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

To provide the information you've requested about acceptance criteria and study details, I would need access to the actual 510(k) summary or the full submission for K081178, which would typically contain performance data and clinical study details if they were required for the specific device type.

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The OPTIMUM GP (roflufocon A, B, C, D & E) 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/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methvi methacrylate. 1.1.3.3.3 - Hexafluoroisopropyl Methacrylate. Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrviic acid cross-linked with Ethylene Glycol Dimethacrylate. The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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 Contact Lens with UV Blocker, a Benzophenone UV blocker 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 280mm - 315mm and 95% in the UVA range of 316 - 380nm.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of algorithm-driven performance metrics (like sensitivity, specificity, or reader improvement).

Instead, the document is a 510(k) summary for a contact lens (OPTIMUM GP Daily Wear Contact Lens) seeking additional indications for use. The core of the submission is to demonstrate substantial equivalence to existing predicate devices, implying that the new indications for use do not raise new questions of safety or effectiveness.

Here's a breakdown of the specific points requested, based on the provided text:

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

The document does not present "acceptance criteria" in the typical sense of quantitative performance metrics for an AI/algorithm driven device. Instead, it focuses on the lens's physical properties and its "substantial equivalence" to predicate devices for its intended use. The closest elements to 'performance' are the physical properties.

2. Sample size used for the test set and the data provenance:

Not applicable. This is a contact lens seeking additional indications, not an AI/algorithm device that would typically have "test sets" of data for performance evaluation in that manner. The submission relies on material properties and clinical experience with similar devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document does not describe the establishment of ground truth by experts in the context of a "test set" for an algorithm.

4. Adjudication method for the test set:

Not applicable. No "test set" or adjudication method is described for an algorithm performance study.

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:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used:

Not applicable in the context of an algorithm's performance validation. The "ground truth" for the device's safety and effectiveness for the additional indications is implicitly established by the long-standing safe and effective use of the identified predicate devices with the same indications, and the physical/chemical similarity of the OPTIMUM GP lens to those predicates.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm device that uses a "training set."

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

Not applicable.

Summary of the Study that Proves Acceptance Criteria are Met (based on the provided text):

The "study" or justification for meeting acceptance criteria for this device is entirely based on demonstrating substantial equivalence to legally marketed predicate devices. The document highlights:

• Identical Indications for Use: The requested indications for use for the OPTIMUM GP lens are the same as those for the predicate devices (Boston ES®, Boston EO®, Boston XO® RGP contact lenses and Dyna Intra-Limbal Lens).
• Similar Device Characteristics: The OPTIMUM GP lens shares critical characteristics with its predicates, including classification (Class II, HQD), production method (lathe-cut), FDA Group # (Fluoro Silicone Acrylate), water content (<1%), and availability of UV absorber/blocker.
• Material Properties: The physical properties (Refractive Index, Light Transmission, Wetting Angle, Specific Gravity, Oxygen Permeability) of the various roflufocon types (A, B, C, D, E) are provided, suggesting that these properties are within acceptable ranges for rigid gas permeable lenses used for the stated indications, akin to the predicates.
• Prior Approval: The Safety and Efficacy and description of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens was previously demonstrated in 510(k) K0033594, indicating it was already approved for daily wear. This current submission is for additional indications.

Therefore, the "proof" that the device meets "acceptance criteria" for its new indications is derived from its fundamental similarity to predicate devices that are already legally marketed for those same indications, along with its previously established safety and efficacy for daily wear. No separate performance study on a "test set" in the context of algorithm evaluation is present.

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