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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":

• Average Sessile Drop Contact Angle (coated): 37.34° (improved from 106.2° uncoated)
• Oxygen Permeability (Dk): $180 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) - Higher Dk than both predicate roflufocon materials, and predicate K103561 at $160 \times 10^{-11}$
• UV blocking (optional) and other physical attributes found to be acceptable and within range typically for RGP lenses. |
  | II. Safety and Effectiveness (Non-Clinical Studies): | |
  | - Biocompatibility (non-toxic, non-irritating) | Finished lenses (uncoated and coated with Tangible™ Hydra-PEG) are not toxic and not irritating. |
  | - Physicochemical, mechanical, and optical properties | Substantially equivalent to the predicate device. |
  | - Bioburden levels | Below acceptance criteria (

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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.

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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.

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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.

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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:

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The CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (nyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

The CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

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 CONTAFLEX 54 Spherical Soft (hydrophilic) Contact Lenses are fabricated from hioxifilcon D, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2.3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

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 (hioxifilcon D) soft hydrophilic contact lens has a spherical 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index 1.5193 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 54 % ± 2%
Specific Gravity (wet) 1.120
Oxygen Permeability 20.96 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

The CONTAFLEX 49 Spherical Soft (hydrophilic)Contact Lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon B) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 51% hioxifilcon B and 49% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint. [phthalocvaninato (2-)] copper. The hioxifilcon B name has been adopted by the United States Adopted Names Council (USAN).

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 (hioxifilcon B) soft hydrophilic contact lens has a spherical 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

Refractive Index 1.5164 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 49% ± 2%
Specific Gravity (wet) 1.140
Oxygen Permeability 16.09 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

This prompt is asking for a structured summary of acceptance criteria and device performance based on the provided FDA 510(k) submission document for Contaflex contact lenses. However, the document provided is a 510(k) Summary and Determination Letter, not a study report. As such, it does not contain the detailed information required to answer all parts of your request, particularly regarding specific study designs, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case (MRMC) studies.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of physical properties and toxicology, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way you've outlined for an AI/diagnostic device.

Here's an attempt to extract the information that is available and explain what is missing:

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

For medical devices, especially contact lenses in a 510(k) submission, "acceptance criteria" are often tied to demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness. The performance is demonstrated by comparing the new device's characteristics to those of the predicate.

Below is a table constructed from the "Substantial Equivalence Matrix" (Page 8), showing the comparison of the subject devices (Contaflex 54 and 49) with their respective predicate devices (BENZ-G 4X and BENZ-G 3X). The acceptance criteria, implicitly, are that the subject devices' properties are comparable to or fall within an acceptable range of the predicate devices.

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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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