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The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in 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 IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The IntelliWave3 multifocal (efrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eves that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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 or hydrogen peroxide disinfection systems.

The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to became soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) 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 (efrofilcon A) 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.

This document describes a 510(k) premarket notification for the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens. It does not present acceptance criteria or a study proving that the device meets them in the traditional sense of a performance study with defined metrics and a test set.

Instead, the submission aims to demonstrate substantial equivalence to a previously cleared predicate device (also named IntelliWave3, K100221) by showing that it has:

• Similar technological characteristics.
• Similar indications for use.
• No new questions of safety or effectiveness.

Therefore, many of the requested items in your prompt are not applicable to this type of submission. Below is a breakdown based on the provided text, indicating where information is present or absent:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance metrics against a predefined threshold. The "reported device performance" refers to its measured physical properties and the results of non-clinical bench testing and biocompatibility studies, which are compared against those of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Detailed breakdown of your requested information:

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

   • See table above. The "acceptance criteria" are implied by demonstrating substantial equivalence, meaning the new device performs similarly to or better than the predicate, and meets relevant safety standards. For internal manufacturing parameters, specific tolerances are listed.

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

   • This submission does not involve a clinical test set or patient data in the way a diagnostic AI device might. The "testing" refers primarily to non-clinical bench testing of the physical contact lenses and material properties. The sample sizes for these tests (e.g., number of lenses tested for Dk, water content, tensile strength, or in toxicology studies) are not specified in this summary.
   • The provenance (country of origin, retrospective/prospective) is not applicable as there are no clinical studies on human subjects described in this 510(k) summary.

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

   • Not applicable. This submission is for a medical device (contact lens), not an AI/ML diagnostic or image analysis device that would require expert-established ground truth on a test set. The ground truth for performance is established through standardized physical, chemical, and biological testing methods.

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

   • Not applicable. There is no clinical test set requiring adjudication in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a contact lens and does not involve AI assistance or human readers.

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

   • Not applicable. This device is a physical contact lens; there is no algorithm involved.

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

   • For the physical and chemical properties, the "ground truth" is based on measurements obtained using standardized laboratory methods (e.g., ISO standards for Dk, preservative uptake/release).
   • For biocompatibility, the "ground truth" is established by results from validated biological tests (e.g., ISO 10993 series for cytotoxicity, systemic toxicity, irritation, sensitization).
   • There is no "expert consensus" or "pathology" in the context of clinical disease for this submission, as clinical studies were deemed unnecessary.

8. The sample size for the training set:

   • Not applicable. This submission does not involve machine learning or a "training set."

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

   • Not applicable. There is no "training set" in this submission.

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The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism.

Eye care 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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.

The provided document is a 510(k) summary for a contact lens device, the Ampleye Scleral RGP Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results for device performance (e.g., accuracy, sensitivity, specificity, statistical significance with effect size) is not present for this contact lens device in this particular document.

Here's how to interpret the document in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria for a "device performance" study (e.g., accuracy metrics) are provided.
• Instead, the "performance" demonstrated is the ability to manufacture lenses to established finished product specifications within ANSI Z80.20-2016 tolerance and bioburden levels within acceptance criteria. These are manufacturing and safety standards, not clinical performance metrics in the sense of predictive or diagnostic accuracy.

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The Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. 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 Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated 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 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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 or hydrogen peroxide disinfection systems.

The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, 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, (safrofilcon A) is a daily wear silicone hydrogel contact lens that is characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are 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 (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness.

This document (K152046) is a 510(k) premarket notification for a new class II medical device, the Intelliwave4 with HPT (Hydra-PEG Technology) Silicone Hydrogel Daily Wear Soft Contact Lens. It is not an AI/ML medical device and therefore does not include the detailed information requested in the prompt regarding AI model performance, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (IntelliWave4, K142641) by showing that the addition of Hydra-PEG Technology (HPT) to the contact lens surface, while enhancing certain physical properties, does not change the core functionality, intended use, or safety profile of the device.

However, based on the provided document, I can extract and infer some information relevant to the concept of acceptance criteria and the study that proves the device meets them, specifically concerning the physical and material properties, and clinical performance for equivalence.

Here's an attempt to structure the information based on your prompt, acknowledging the limitations due to the nature of the document:

Device: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

This device is not an AI/ML driven diagnostic or assistive tool, but rather a physical medical device (contact lens). Therefore, many of the specific criteria related to AI performance, such as MRMC studies, expert adjudication for ground truth of an algorithm, and effect sizes of AI assistance, are not applicable here. The "acceptance criteria" discussed are related to the physical properties, safety, and effectiveness of a contact lens compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds in the same way an AI model might have for metrics like AUC or sensitivity/specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device, particularly that the new HPT treatment does not negatively impact safety or core performance, and ideally improves certain physical properties of the lens surface.

The table below summarizes the enhanced surface properties of the new device compared to the predicate device, which implicitly serve as a form of "performance acceptance" in the context of demonstrating improvement while maintaining safety. Clinical performance is evaluated for "similar overall performance."

Note: The "acceptance criteria" for improved properties are implicitly that the new device performs significantly better than the predicate for beneficial characteristics, and for other properties (like water content, oxygen permeability), the criterion is to be substantially equivalent.

2. Sample Size and Data Provenance for Test Set (Clinical Study)

• Sample Size for Test Set: 30 patients
• Data Provenance: The document does not specify the country of origin. It describes a "bilateral, open-label, parallel group, and randomized daily wear study." It is a prospective clinical study.

3. Number of Experts and Qualifications for Ground Truth

• Applicability for this device: Not directly applicable in the typical AI/ML sense of establishing ground truth for image interpretation or diagnosis.
• Context for this device: The clinical study evaluated safety and efficacy. The "experts" would be the eye care practitioners supervising the study and assessing clinical outcomes (vision, health, comfort, fit). The document does not specify the number or qualifications of these practitioners, but they would be licensed professionals involved in contact lens prescribing and care.

4. Adjudication Method for the Test Set

• Applicability for this device: Not explicitly stated as an adjudication method for a "test set" in the AI/ML context.
• Context for this device: The clinical study's design (open-label, parallel group, randomized) implies standard clinical trial methodology for data collection and analysis to ensure unbiased assessment of patient outcomes. Decisions on "ground truth" (e.g., whether a lens fits well, or whether vision is adequate) would be made by the trained clinicians participating in the study as part of their standard practice.

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

• Was an MRMC study done? No. This type of study is specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance

• Applicability for this device: Not applicable. This device is a physical contact lens, not a software algorithm. Its "performance" is inherent in its physical and material properties, and its clinical performance when worn by a human.

7. Type of Ground Truth Used

• For physical/material properties: Quantitative measurements derived from in vitro tests (e.g., contact angle, friction, WBUT, water content, oxygen permeability). These are objective measurements from laboratory equipment.
• For clinical safety and effectiveness: Patient-reported outcomes (comfort), clinician assessments (vision, health, fit), and observations during a clinical study. This is essentially outcomes data and clinical assessment.

8. Sample Size for the Training Set

• Applicability for this device: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.
• Context for this device: The device development would involve R&D, material science, and manufacturing process development, but not a "training set" as understood for AI.

9. How Ground Truth for the Training Set Was Established

• Applicability for this device: Not applicable for an AI/ML context.
• Context for this device: For physical and material properties, the "ground truth" for development and manufacturing is established through standard laboratory testing methods and material science principles, ensuring the lens meets specified manufacturing tolerances and material compositions. For safety and biocompatibility, this is established through pre-clinical toxicology and biocompatibility tests conducted according to GLP regulations.

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The Intelliwave4, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. 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 Intelliwave4, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4, irregular cornea (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the eye.

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 or hydrogen peroxide disinfection systems.

The Intelliwave4 Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, 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 (safrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) 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 (safrofilcon A) 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.

In the Intelliwave4 Contact Lens with UV Blocker and center thickness of 0.18mm, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2-(4-Benzoyl-3-hydroxyphenoxy)ethyl acrylate. The UV blocking for Intelliwave4 lenses averages > 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380mm.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.

The provided text describes the Intelliwave4 contact lens and its substantial equivalence to a predicate device, IntelliWave3. It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of regulatory submission does not typically involve detailed acceptance criteria tables or studies designed to "prove" a device meets acceptance criteria in the way a novel device might. Instead, it relies on demonstrating equivalence through comparison of design, materials, and clinical performance.

However, based on the information provided, I can extract the closest parallels to your requested categories:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for specific performance metrics in a table. Instead, it compares the new device (Intelliwave4) to a predicate device (IntelliWave3) to demonstrate substantial equivalence. The "performance" is described in terms of safety and efficacy being "similar overall performance" to the predicate.

Here's a table reflecting the comparative properties and a summary of performance as reported:

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

• Test set sample size: 60 patients
• Data provenance: Not explicitly stated regarding country of origin, but the study was a "bilateral, open-label, parallel group, and randomized daily wear study" which indicates a prospective design. Given the FDA submission, it implicitly refers to data relevant for US regulatory purposes, likely with US or internationally recognized standards.

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

This information is not provided in the document. The clinical study details are very brief. It mentions "Clinical evaluation demonstrated similar overall performance," but it does not specify the number or qualifications of clinicians involved in assessing "vision, health, and comfort and fit."

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

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool. The clinical study compares the new contact lens to a predicate contact lens.

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

This is not applicable. The device is a contact lens.

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

The "ground truth" for the clinical study was the clinical evaluation of 60 patients over three months, assessing "vision, health, and comfort and fit." This falls under outcomes data or clinical assessments by potentially multiple clinicians, although the specific number and qualifications are not detailed.

8. The sample size for the training set

This is not applicable in the context of this device. A training set is typically for machine learning algorithms. The Intelliwave4 contact lens is a physical medical device. The "training" for its development would involve material science, engineering, and manufacturing, not a data-based training set.

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

This is not applicable for the reasons stated in point 8.

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The IntelliWave3, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-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 IntelliWave", toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated I he correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The IntelliWave", multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave", multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave', irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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 or hydrogen peroxide disinfection systems.

The IntelliWave3 Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, 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, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) 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 (efrofilcon A) soft birghilic 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 provided text describes the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens and its substantial equivalence determination by the FDA. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/medical device.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of specific, quantifiable acceptance criteria. The document states that "Clinical evaluation demonstrated similar overall performance to the predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear." This is a general statement of comparative performance rather than a list of specific acceptance metrics with target values and the device's measured performance against them.

The document does list physical properties of the lens:

The "acceptance criteria" for these physical properties are implicitly that they fall within acceptable ranges for contact lenses and are comparable to predicate devices, but explicit criteria are not given. For clinical performance, the criterion seems to be "similar overall performance" to the predicate in key areas.

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

The document states:

• Sample Size: "The study evaluated 63 patients over a three (3) months period."
• Data Provenance: Not explicitly stated (e.g., country of origin). It also does not specify if the data was retrospective or prospective, although the description of a "bilateral, open-label, parallel group, and randomized daily wear study" strongly suggests it was prospective clinical data.

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

This information is not provided. The "ground truth" for clinical performance likely relies on standardized ophthalmic examinations and patient-reported outcomes, but the adjudication process by experts is not detailed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This is not applicable as the device described is a physical medical device (contact lens), not an AI algorithm intended to assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable as the device is a physical contact lens, not an AI algorithm. Its performance is inherent in its physical and clinical characteristics when worn by a human.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" was established through standard scientific protocols and toxicology studies according to GLP regulations, indicating laboratory measurements and biological response assessments (e.g., sterility, toxicity, irritation).

For the clinical study, the "ground truth" on performance likely involved:

• Vision: Visual acuity measurements.
• Health: Ophthalmic examinations by eyecare practitioners (e.g., assessing corneal health, ocular surface).
• Comfort and Fit: Patient-reported outcomes and clinical assessment of lens fit by eyecare practitioners.

The comparison was to a "predicate control," meaning direct comparison of these clinical outcomes between the new lens and an existing, legally marketed lens.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device and not an AI algorithm that requires a training set.

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

This is not applicable for the same reason as above.

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The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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 IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily, wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave2, Multifocal Toric (Ilioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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

The IntelliWave1, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this matcrial allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121.

The IntelliWave2, Soft Daily Wear 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 copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).

The provided text is a 510(k) Summary for contact lenses and does not describe a study that uses acceptance criteria and reports device performance in the way typically seen for AI/ML devices or diagnostic tools. Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices.

Therefore, many of the requested points related to a study, ground truth, expert review, and AI performance metrics are not applicable here.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) summary is centered on demonstrating that the new devices (IntelliWave1 and IntelliWave2 contact lenses) are substantially equivalent to their predicate devices. The acceptance criteria for substantial equivalence are met when the new devices have the "same as predicate device" characteristics across several key attributes.

Table of Acceptance Criteria and Reported Device Performance:

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