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The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

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.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear 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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wear 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 Boston Scleral Lenses may concurrently provide correction of refractive error.

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

Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are 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 is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The provided document is a 510(k) Premarket Notification for Bausch & Lomb's Boston ES®, Boston EO®, Boston XO®, and Boston XO2® Rigid Gas Permeable Contact Lenses with a new Tangible™ Hydra-PEG surface coating. This document details the company's claim of substantial equivalence to previously cleared predicate devices, rather than presenting a study for a novel AI/software as a medical device (SaMD).

Therefore, the information requested for acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device proving AI/software performance is not present in this document.

This submission focuses on demonstrating the safety and effectiveness of a modified contact lens product by comparing its technological characteristics and performance (primarily wettability and biocompatibility) to already cleared devices. The "performance data" sections refer to non-clinical (toxicology, biocompatibility, stability) and clinical (based on predicate device history) testing relevant to contact lenses, not AI model performance.

The only "acceptance criteria" explicitly mentioned and met are related to quality control for the contact lenses:

Other "performance" details provided are for the material properties related to the new coating, not AI performance metrics:

Summary of missing information (as it pertains to AI/SaMD):

• 1. A table of acceptance criteria and the reported device performance: Only general biocompatibility and bioburden criteria for the contact lens are mentioned. AI-specific performance criteria (e.g., sensitivity, specificity, F1 score) are not applicable or provided.
• 2. Sample sized used for the test set and the data provenance: No test set for AI performance is described. The document refers to "non-clinical testing" (in vitro and in vivo toxicology/biocompatibility) but does not provide specific sample sizes in a test set context for AI.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth for AI model testing is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" for this device would refer to established biological and material science standards for contact lens safety and performance.
• 8. The sample size for the training set: Not applicable; this is a physical medical device, not an AI/ML model being trained.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document is a regulatory submission for a contact lens modification and does not contain the type of AI/SaMD performance study details requested in the prompt.

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FluoroPerm® 92 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 92 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 60 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 60 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 60 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® rigid gas permeable spheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses with Tangible Hvdra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eyes.

FluoroPerm® 30 rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 30 rigid gas permeable spheric and bifocal contact lenses with Tanzible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 30 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 30 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon Thin rigid gas permeable contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin'm toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon Thin™ contact lenses with Tangible Hydra-PEG are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise non-diseased eves.

FluoroPerm® 151 rigid gas permeable spheric contact lenses with Tangible Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 toric contact lenses with Tangible Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses with Tangible Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, FluoroPerm® 151 contact lenses with Tangible Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration. or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses with Tangible™ Hydra-PEG are indicated for daily wear as recommended by the eye care practitioner.

Paragon HDS® 100 rigid gas permeable spherical, aspheric and bifocal contact lenses with Tangible™ Hydra-PEG are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses with Tangible™ Hydra-PEG are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses with Tangible™ Hydra-PEG are indicated to treat presbyopia up to +4.00 D add power.

In daily wear use only, Paragon HDS® 100 contact lenses with Tangible™ Hydra-PEG are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.

FluoroPerm® 30, Paragon Thin™, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 92, FluoroPerm® 151 & Paragon HDS® 100 lenses with Tangible™ Hydra-PEG are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the following currently marketed contact lens materials: paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30. Paragon Thin™), paflufocon D (FluoroPerm® 151, Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve. The FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm ® 30, Paragon Thin™ FluoroPerm®151, and Paragon HDS® 100 lenses are 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 is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The provided text describes a 510(k) premarket notification for various rigid gas permeable (RGP) contact lenses treated with Tangible™ Hydra-PEG. It details the device, its intended use, and a comparison to predicate devices, but it does not include a detailed study with specific acceptance criteria and performance metrics (like sensitivity, specificity, AUC) typically found in AI/ML device studies.

The "Acceptance Criteria" provided in the document refers to the general safety and effectiveness of the contact lenses, focusing on material properties, biocompatibility, and stability, rather than diagnostic performance metrics. The "study" mentioned is primarily non-clinical and previous clinical data from predicate devices.

Therefore, I cannot populate the table and answer the study-specific questions as they would apply to an AI/ML diagnostic or prognostic device study. Instead, I will extract the information that is present regarding the device's characteristics and the evaluations conducted.

Here’s a summary based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for contact lenses with a surface coating, the "acceptance criteria" are related to biocompatibility, material properties, and stability, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity) for AI/ML devices. The key performance metric explicitly reported is wettability.

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

The document describes non-clinical (in vitro and in vivo toxicology, biocompatibility, stability) and previous clinical testing. It does not specify a "test set" in the context of an AI/ML study (i.e., a dataset used to evaluate a trained algorithm's performance).

• Sample Size: Not specified for individual non-clinical tests. General "series of in vitro and in vivo preclinical toxicology and biocompatibility tests" were performed.
• Data Provenance: Not explicitly stated, but the studies were "conducted in accordance with the GLP regulation" and "valid scientific protocols." Clinical data was drawn from previous PMA P870024 and its supplements for the underlying materials, and clinical safety and effectiveness for Hydra-PEG treated lenses were "previously demonstrated" (likely referring to the reference predicate K161100). This indicates a blend of new non-clinical testing and leveraging existing clinical data (retrospective from prior approvals).

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

Not applicable. This is not an AI/ML diagnostic study that relies on expert interpretation to establish ground truth. The evaluation focused on physical, chemical, and biological properties of contact lenses.

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

Not applicable. This type of adjudication method is relevant for expert-based ground truth in AI/ML diagnostic studies, which is not the case here.

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/ML device, and no MRMC study was conducted.

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

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

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

The "ground truth" here is based on:

• Measurement of physical/chemical properties: Such as sessile drop contact angle, bioburden levels using established laboratory methods.
• Biocompatibility standards: Evaluated through preclinical toxicology and irritation tests.
• Stability testing: Physical properties of the lenses under various conditions.
• Previous clinical data: Demonstrating the safety and effectiveness of the base contact lens materials (PMA P870024) and the Hydra-PEG coating (K161100).

8. The sample size for the training set

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

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

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

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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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