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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 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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