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The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes and or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) 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 Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) 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 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 RB246 (1,4-Bis[4-(2-Methacryloxyethy]) phenylamino]-9, 10-Anthraquinone) as an integrated handling tint. The lenses are made by lathe-cut for individual patients. 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

This document is a 510(k) Pre-market Notification for a contact lens, specifically the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria.

Based on the provided text, a conventional acceptance criteria table and performance study of an AI/algorithm-driven device meeting those criteria cannot be constructed because:

• The device is a physical product (contact lens), not an AI/algorithm system.
• The document describes a "Special 510(k) Summary," which typically relies on demonstrating equivalence to legally marketed predicate devices rather than proving performance against novel clinical acceptance criteria through new clinical trials.
• The document explicitly states "Clinical testing was not necessary for this application."

However, I can extract the bench test performance data and compare it to reported values of the predicate devices, which serves as a form of "acceptance criteria" for demonstrating substantial equivalence for a physical product by showing similar physical and chemical properties.

Here's the information structured to best fit your request, interpreting "acceptance criteria" as the properties of the predicate devices that the new device aims to match or be comparable to:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a contact lens, "acceptance criteria" in this context refer to physicochemical properties that demonstrate the new device is comparable to legally marketed predicate devices. The "reported device performance" refers to the measurements taken on the Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).

Note: The document states that the Flexlens Silicone Hydrogel device is "substantially equivalent" to both predicate devices. The table above shows that its properties align perfectly with one (K230824) and are very close to the other (K100443). The small differences (e.g., Dk value relative to K100443, Visible light transmission relative to K100443) were deemed non-relevant for substantial equivalence by the manufacturer.

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

• Test Set Description: Non-clinical (bench) testing was conducted.
• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of lenses tested for Dk, water content, etc.). It refers to "Bench Testing-manufacturing verification testing" to demonstrate ability to manufacture lenses "on a repeatable basis" to established specifications, and "Performance Testing" for various physicochemical properties.
• Data Provenance: The data is from non-clinical (bench) tests performed by the manufacturer (X-CEL SPECIALTY CONTACTS) or a lens material manufacturer for testing of efrofilcon A contact lens blanks. The location is implied to be within the United States, given the FDA submission context. The data is retrospective in the sense that it represents lab measurements, not a prospective clinical trial.

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

This question is not applicable. The "ground truth" for a physical device's characteristics (like refractive index, water content, Dk) is established through standardized laboratory measurement methods (e.g., ISO standards), not by expert consensus or interpretation of images.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or for interpreting subjective data (like image readings), which was not conducted or required for this device's submission. The "adjudication" for bench tests would be the adherence to validated testing methodologies and equipment calibration.

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 question is not applicable. This is not an AI/algorithm device, and no MRMC study was performed as clinical testing was not necessary.

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

This question is not applicable. This is not an AI/algorithm device.

7. The type of ground truth used

The "ground truth" for the non-clinical tests (physicochemical properties like Dk, water content, refractive index, etc.) are the measurements obtained using standardized laboratory testing methods (e.g., ISO standards for Dk, preservative uptake/release). For biocompatibility, the ground truth is established by adherence to GLP regulations and ISO 10993 standards, with results like "not cytotoxic," "no evidence of systemic toxicity," "no ocular irritation," and "did not produce skin sensitization."

8. The sample size for the training set

This question is not applicable. This is not an AI/algorithm device that requires a training set. The device manufacturing processes are based on established engineering principles and material science.

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

This question is not applicable. There is no "training set" for this physical device.

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The Definitive, Flexlens, 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 Definitive, Flexlens, 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 Definitive, Flexlens, 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 eves and/or possesses refractive astigmatism not exceeding . 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flextens, 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 Definitive, Flexlens, 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 Definitive, Flexlens 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 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 D&C Green 6 as an integrated handling tint. 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Acceptance Criteria and Study Findings for Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

This document describes the acceptance criteria and the study that demonstrated the Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) meets these criteria, based on the provided 510(k) summary (K100443).

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are primarily established by its substantial equivalence to predicate devices, meaning its physical properties, intended use, and safety/effectiveness are comparable. The study did not define explicit numerical acceptance criteria for clinical performance but focused on demonstrating equivalence.

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

• Sample Size: Not applicable for clinical testing of the current device. The document explicitly states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." The current submission relies on the established performance of the material (efrofilcon A) which is part of the predicate device "Intelliwave³ (efrofilcon A)" (K100221).
• Data Provenance: Not specified for the historical clinical data related to the efrofilcon A material. However, all non-clinical toxicity and biocompatibility tests for the current device were conducted in accordance with GLP (Good Laboratory Practice) regulations, implying controlled laboratory settings rather than human subject testing in the context of this specific 510(k). The non-clinical data is prospective as it was specifically performed for this submission. The country of origin is not specified.

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

Not applicable. No new clinical studies were conducted for this 510(k) submission, and therefore no "experts" were used to establish a ground truth for a test set in the context of a new clinical evaluation. The ground truth for safety and effectiveness is established by the previous clearance of the predicate device (Intelliwave³ efrofilcon A) and the inherent properties of the efrofilcon A material.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication was used in this 510(k) submission.

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

Not applicable. This was not a diagnostic device involving a multi-reader multi-case (MRMC) study. The device is a contact lens, and its effectiveness is determined by its physical properties, biocompatibility, and functional equivalence to legally marketed predicate devices.

6. Standalone Performance Study

A standalone performance study for the clinical effectiveness of the algorithm (device) was not explicitly conducted as part of this 510(k) submission. The submission relies on the established clinical performance of the efrofilcon A lens material from prior clearances.

However, various non-clinical (in vitro and in vivo preclinical toxicology and biocompatibility) tests were performed on the Definitive, Flexlens device in a standalone manner to assess its safety. These tests assessed:

• Sterility
• Packaging material and extract toxicity/irritation
• Lens physical and material properties

7. Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness in this 510(k) is based on:

• Substantial Equivalence: The primary ground truth is the established safety and effectiveness of the predicate devices, particularly the "IntelliWave', Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" (K100221), to which the new device is stated to be identical in material and manufacturing process.
• Non-clinical Testing: Laboratory testing (toxicology, biocompatibility, sterility, shelf-life) performed according to GLP regulations and valid scientific protocols provided ground truth for these specific safety aspects.
• Previously Established Clinical Performance: The document states, "The clinical performance of the (efrofilcon A) lens material has been previously established," indicating reliance on prior clinical data for the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a medical device (contact lens), not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process does not involve machine learning.

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

Not applicable, as there is no "training set" for this type of device.

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The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is indicated for daily wear use for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in non-aphakic persons.

The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is a lathe-cut soft lens multifocal with an aspheric front surface and a spherical base curve. In the dry (unhydrated) state the lens is machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The progressive optics utilize the simultaneous vision concept which offers functional vision from distance to near throughout the viewing range. The pupil zone on the front surface varies with the size of the patient's pupil.

The non-ionic lens material, hioxifileon A, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight. when immersed in normal saline solution buffered with sodium bicarbonate. Flexlens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon A are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

The non-ionic lens material, hioxifileon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifilcon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. FlexIens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon B are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

The provided document, K070308, is a 510(k) summary for the Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear. It clarifies that this is a premarket notification for a Class II medical device, and the FDA has determined it to be substantially equivalent to legally marketed predicate devices.

Crucially, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a de novo study with specific acceptance criteria and detailed performance data often seen in AI/algorithm-based device submissions.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not explicitly present in this 510(k) summary. The document primarily refers to "Pre-Clinical Performance Data" in previous 510(k) submissions for the materials themselves (hioxifilcon A and B).

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional contact lens submission, specific "acceptance criteria" and "device performance" metrics in the context of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) are not described. Instead, the document focuses on the physical and optical properties of the lens materials.

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

This information is not provided in the 510(k) summary. The document references "Pre-Clinical Performance Data" in other 510(k) submissions (K983773 and K964528) for the hioxifilcon A and B materials, but it does not detail the specific studies, sample sizes, or data provenance conducted for this particular multifocal lens design.

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

This information is not provided in the 510(k) summary. It's not relevant for a traditional contact lens submission focused on physical/optical properties and chemical composition.

4. Adjudication method for the test set

This information is not provided and is not relevant for the type of device and submission described.

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

No, a MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device, but a contact lens.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to AI/ML diagnostics (e.g., pathology, outcomes data) is not applicable here. The "truth" for this device relates to its physical, chemical, and optical properties meeting established standards for contact lenses and being comparable to legally marketed predicate devices.

8. The sample size for the training set

This information is not provided and is not relevant as this is not an AI/ML device.

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

This information is not provided and is not relevant as this is not an AI/ML device.

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The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty.

The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

The lens may be disinfected with a chemical (not heat) disinfection system.

The Flexlens and Harrison Post Refractive Surgery (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) is fabricated from one of the above materials 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.

In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The provided text describes a 510(k) submission for new contact lens materials, not a study proving device performance against acceptance criteria in the typical sense of a clinical or AI performance study. The submission focuses on demonstrating substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's a breakdown of the relevant and non-applicable information based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context are the characteristics and performance values that demonstrate substantial equivalence to legally marketed predicate contact lenses. The device performance is assessed by comparing these characteristics of the new materials to those of the predicate materials.

*Note: Oxygen Permeability units are (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

Study Details Table

This submission is a 510(k) Pre-Market Notification for substantial equivalence for new materials for an existing device, not a performance study (e.g., clinical trial) in the traditional sense that would generate new patient-specific data for acceptance criteria. The "study" here is primarily a comparison of material properties and intended uses to predicate devices.

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The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of a copolymer of 2hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolldone (NVP), which yield the appearance of lenses, which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6 mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

This document is a 510(k) Summary for a contact lens device, not a study report describing acceptance criteria and performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present.

However, I can extract the information provided about the device's technical specifications and how its "substantial equivalence" to a predicate device serves as the basis for its market acceptance.

This document does not contain information about:

• Acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for a study.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (pathology, outcomes data, etc.) for a study.
• How ground truth for a training set was established.

Information Extractable from the Provided Document:

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

The acceptance for this device is based on "substantial equivalence" to a legally marketed predicate device. The document does not describe performance metrics in the way one would for an AI/algorithm-based device (e.g., accuracy, sensitivity, specificity). Instead, it compares the physical, optical, and chemical properties, material, indications for use, and method of manufacture to the predicate device. The "acceptance criteria" here are effectively that these characteristics are sufficiently similar to the predicate to establish substantial equivalence.

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

Not applicable. This is a contact lens submission based on substantial equivalence, not an AI/algorithm study with test sets and data provenance.

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

Not applicable. Ground truth for a test set is not mentioned as this is a device clearance based on substantial equivalence.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

Not applicable. This is not an algorithm-only device.

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

For this type of device (contact lens), the "ground truth" for "acceptance" is its physical, chemical, and optical properties and its intended use, which are verified against a predicate device and established material classifications (e.g., FDA Group 1 for materials). There isn't a "ground truth" in the diagnostic or prognostic sense.

8. The sample size for the training set:

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

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

Not applicable.

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The FLEXIENS (hefilcon A) HARRISON Post Refractive Surgery Contact Tens is indicated for Daily Wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

The FLEXI.ENS (hefilcon A) Harrison Post Refractive Surgery Contact Lens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric base curve and a spherical front surface. The lens is lathe cut from hefilcon A, a hydrophilic random copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone crosslinked with ethylene glycol dimethacrylate. It consists of 55% hefilcon A and 45% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

Here's a breakdown of the acceptance criteria and study information for the FLEXLENS (hefilcon A) HARRISON Post Refractive Surgery Lens, based on the provided text:

Important Note: The provided text is a "SUMMARY of SAFETY AND EFFECTIVENESS" for a 510(k) submission, which often relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical trials with detailed statistical analyses for specific acceptance criteria. Therefore, the information regarding acceptance criteria and performance is limited and often inferred from the overall claim of equivalence.

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 10 patients (12 eyes)
   • Data Provenance: A small clinical study run in Canada. Retrospective/Prospective status is not explicitly stated, but "a small clinical study that was run" suggests it was a prospective observation of patients fitted with the lens.

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

   • Number of Experts: One principal investigator.
   • Qualifications: Keith W. Harrison, FCLSA (Fellow of the Contact Lens Society of America). Specific years of experience are not mentioned.

3. Adjudication method for the test set:

   • Not specified. Given it was a "small clinical study" with one principal investigator, it's highly probable there was no formal, multi-expert adjudication method like 2+1 or 3+1. The principal investigator likely made the assessments.

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

   • No. This is a medical device (contact lens), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

   • No. This is a physical medical device. Standalone algorithm performance is not relevant.

6. The type of ground truth used:

   • The "ground truth" for the clinical study appears to be the clinical assessment of visual acuity improvement and patient tolerance/comfort by the principal investigator, potentially based on standard ophthalmic examinations and patient feedback. The text highlights the lens's ability to "improve the visual acuity" for these specific patient groups.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated for this specific device's clinical study. The product claims "equivalence" to other hefilcon A lenses. The "pre-clinical" sections (Toxicology, Microbiology, Compatibility, Stability, Preservative Uptake Tests) refer to data from the original hefilcon A material (N17-976, approved FDA 01/04/1979). This prior approval and accumulated data for the material could be considered a form of "training data" for understanding the base material's safety and effectiveness, but it's not a training set in the context of machine learning.

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

   • As noted above, a "training set" as understood in a machine learning context is not relevant here. The ground truth for the underlying hefilcon A material (N17-976) would have been established through a combination of laboratory testing, pre-clinical studies, and prior clinical trials/experience as part of its original FDA approval process in 1979. For the new Harrison design, the "training" for its design came from addressing known issues with conventional lenses in post-refractive surgery eyes, as detailed in the "Device Description" section.

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The FLEXI.ENS 55 (methafilcon A) HARRISON Post Refractive Surgery Contact Tens is indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

The FIFXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear is a soft (hydrophilic) contact lens with a spherical or toric hase curve and a spherical front surface. The lens is lathe cut from methafilcon A. a random copolymer of 2-hydroxyethy) methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. It consists of 45% methafilcon A and 55% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The physical properties of the lens are as follows:
Refractive Index: 1.4153
Light Transmittance: greater than 95%T
Water Content: 55%
Oxygen Permeability: Dk=18 X 10-11 at 35 °C (measured by the standard Fatt method)
Specific Gravity: 1.090 g/cc

The FT.FXLENS 55 (methafilcon A) Harrison Post Refractive Surgery Contact Tens for daily wear was developed to improve the visual acuity of those patients who require improved vision after photorefractive keratectomy, radial keratotomy, and other corneal refractive procedures. Other factors taken into consideration were the following:

1. The topographical profile is such that it is difficult to achieve a satisfactory posterior lems surface to cornea alignment with rigid gas permeable contact l enses .
2. Conventional soft (hydrophilic) contact lens designs do not readily align with the visual axis of the PRS or RK eye or supply sufficient masking of the corneal astigmatism.
3. Conventional toric soft (hydrophilic) contact lenses are limited in their ability to provide a stable level of visual acuity on cases of extreme central flattening in conjunction with irregular astigmatism.

The Harrison Post Refractive Surgery Lens differs from the standard spherical FLEXIENS Custom Sphere in that it incorporates a flat central optical zone with a thickness which varies with power (-1.00n will be approximately 0.30mm thick at the center). The size of the optical zone is generally 8.0mm. The peripheral carrier is thinner than most standard soft (hydrophilic) contact lenses, approximately 0.08mm to 0.10mm, to ensure limbal draping which will exhibit the characteristics (on the eye) of a peripheral aspheric design. In some cases the periphery is manufactured with a steeper curvature than the base curve.

The provided text describes a contact lens (FLEXLENS 55 (methafilcon A) HARRISON Post Refractive Surgery Lens) and a clinical study associated with it. However, the document does not explicitly state "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance." The study described is more of a re-fitting study to compare two versions of the same lens (different water content) on patients who had already been wearing one version.

Based on the information provided, here's an attempt to answer your questions, highlighting where information is not explicitly available:

Acceptance Criteria and Study Details for FLEXLENS 55 (methafilcon A) HARRISON Post Refractive Surgery Lens

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative acceptance criteria for device performance (e.g., minimum visual acuity improvement, maximum complication rate). The clinical study aims to show "no substantial change from one polymer to the other," implying an equivalence or non-inferiority goal rather than specific performance thresholds.

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

• Sample Size (Clinical Study): 10 patients with 12 eyes.
• Data Provenance: Conducted in Canada. The study was a "refitting" study, meaning patients were already using a previous version of the lens and were then switched to the new version. This suggests a retrospective component (initial fitting data for comparison) and a prospective component (follow-up after refitting with the new lens), though the document describes it as a single "small clinical study."

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

• The principal investigator was Keith W. Harrison, FCSSA. His qualifications are listed as FCSSA (Fellow of the Contact Lens Society of America, or similar professional designation, though not explicitly spelled out in the document).
• The document does not specify additional "experts" involved in establishing ground truth for the clinical study beyond the principal investigator who conducted the refitting and follow-up.

4. Adjudication Method for the Test Set:

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" or assessment of "no substantial change" appears to have been determined by the principal investigator, potentially through clinical examination and subjective patient feedback, but specific methods are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This was a small clinical study focused on refitting patients with a slightly modified version of an existing product. It did not involve multiple readers assessing cases to determine improvement with AI assistance.

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

• Not applicable. This device is a contact lens, not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used:

• The ground truth for the clinical study appears to be based on clinical assessment by the principal investigator and implied patient experience/outcomes (e.g., "no substantial change from one polymer to the other" in terms of performance). The document does not specify objective metrics like visual acuity charts or detailed patient-reported outcomes, but these would likely have been part of the clinical assessment.

8. The Sample Size for the Training Set:

• Not applicable. This is a contact lens, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing and design process relies on established material science and contact lens design principles.

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

• Not applicable, as there is no "training set" for this device. The physical properties (Refractive Index, Light Transmittance, Water Content, Oxygen Permeability, Specific Gravity) are inherent material and design specifications, established through laboratory testing and manufacturing processes for methafilcon A, as referenced in prior 510(k) clearances.

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