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Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The Focus DAILIES and DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.

The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high molecular weight PVA (for Focus DAILIES lenses) and/or ultra-high molecular weight PVA (for Dailies AquaComfort Plus lenses) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.

Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foilblister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (DAILIES AquaComfort Plus products) and/or 0.85 ml (Focus DAILIES products) phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. For DAILIES AquaComfort Plus lenses the package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.

Instead, it is a 510(k) summary for contact lenses (Focus DAILIES and DAILIES AquaComfort Plus) which outlines a modification to an alternate foil lidding material for their primary packaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for traditional medical devices under the 510(k) pathway, not AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details relevant to an AI/ML device from this document.

Here's why and what information is missing:

• No AI/ML Component: The device described is a soft contact lens, a physical medical device. There is no mention of any AI or machine learning component, software, or algorithm in its functionality or development.
• No Performance Metrics for AI: Consequently, there are no AI/ML-specific performance metrics like sensitivity, specificity, AUC, F1-score, etc., nor any acceptance criteria for these.
• No Study Design for AI Validation: The "Performance Data" section discusses:
  • Non-clinical Testing: Stability, biocompatibility, and process validation, referencing ISO standards relevant to material safety and manufacturing for contact lenses. These are not AI/ML validation studies.
  • Clinical Testing: States that clinical testing was not required for this specific modification (changing packaging material), which further confirms the absence of AI/ML validation studies.
• No Mention of Ground Truth, Training Data, Experts: Since there's no AI, there's no need for ground truth establishment, training data, or expert adjudication as would be required for an AI/ML device.
• No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.

In summary, the provided document is not about an AI/ML medical device and therefore does not contain the information you requested.

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Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.
DAILIES TOTAL 1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.
DAILIES TOTAL1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable:
Spherical lenses: Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1
Toric lenses: Focus DAILIES Toric and DAILIES AquaComfort Plus Toric
Multifocal lenses: Focus DAILIES Progressives, DAILIES AquaComfort Plus Multifocal and DAILIES Total1 Multifocal
The lens material of Focus DAILIES, DAILIES AquaComfort Plus and FreshLook One-Day products is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with Nformylmethyl acrylamide) and 69% water. For Focus DAILIES and DAILIES AquaComfort Plus products the lens material further contains non-functionalized PVA (high- and/or ultra-high molecular weight PVA) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint®) to make the lenses easier to see when handling. Additionally, lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue (CFR 74.3045) and phthalocyanine green (CFR 73.3124). FreshLook One-Day color contact lenses are printed with an intermittent coating containing the following pigments (either alone or in combination): iron oxides, titanium dioxide, Cu-phthalocyanine blue, chromium oxide and phthalocyanine green. All pigments are approved color additives for use in contact lenses.
DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. Delefilcon A soft contact lenses are surface coated with hydrophilic components. The lenses contain a color additive (copper phthalocyanine blue) to assist handling tint). In addition, lenses contain 1,2-Dimyristoyl-sn-glycero-3-phosphocholine which is considered a 'comfort agent' to improve lens wearing comfort by physical mode of action (water binding and lens lubricating effect).
Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 products are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top. The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (for DAILIES AquaComfort Plus and DAILIES Total1) and/or approximately 0.85 ml (for Focus DAILIES and FreshLook One-Day) of phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES AquaComfort Plus family lenses additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each (Focus DAILIES, DAILIES AquaComfort Plus, DAILIES Total1) and/or 10 lenses each (FreshLook One-Day), respectively.

This document is a 510(k) premarket notification for contact lenses, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include extensive de novo clinical studies with acceptance criteria for a novel AI device as would be seen for a new technology or an AI/ML diagnostic.

Therefore, the information required to answer the questions about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an AI device is not present in this document.

Instead, this submission focuses on demonstrating substantial equivalence based on:

• Identical Indications for Use: The modified contact lenses have the same intended use as the predicate devices.
• Similar Technological Characteristics: The materials, manufacturing methods, lens designs, sterilization, and basic performance specifications (refractive index, light transmittance, oxygen permeability, elastic modulus) are either identical or very similar to the predicate devices.
• Non-clinical Performance Testing: Biocompatibility and stability testing were performed to show that the minor modifications (primarily to the primary packaging foil lidding supplier) do not negatively impact safety or performance.
• No Clinical Testing Required: Due to the high similarity and successful non-clinical testing, clinical testing was deemed unnecessary to establish substantial equivalence.

In summary, this document is for a medical device (contact lenses) and not an AI/ML-based device. Hence, the detailed criteria for AI device validation (like acceptance criteria for AI performance, MRMC studies, ground truth establishment, etc.) are entirely irrelevant and absent from this submission.

If this question was intended for an AI/ML-based medical device, the provided document does not contain the necessary information.

Ask a specific question about this device

Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

FreshLook spherical (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook spherical (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.

The lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.

DAILIES TOTAL (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL 1 (delefilcon A) multifocal soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism .

The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus DAILIES, DAILIES AquaComfort Plus, FreshLook One-Day and DAILIES Total1 are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs as applicable. The lens material of Focus DAILIES, DAILIES AquaComfort Plus, and FreshLook One-Day products is nelfilcon A. DAILIES Total1 products are made from a silicone hydrogel material containing approximately 33% water and 67% delefilcon A. The lenses are supplied sterile in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave.

This document is a 510(k) premarket notification for several types of soft contact lenses manufactured by Alcon Laboratories, Inc. The purpose of this submission is to demonstrate that the modified devices are substantially equivalent to their legally marketed predicate devices.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics in the way one might expect for a new device claiming improved performance. Instead, it focuses on demonstrating that the modified devices maintain the same performance specifications as their predicate devices. The acceptance criterion implicitly seems to be "no negative impact on safety, efficacy, and performance compared to predicate devices, and consistency with established standards."

The "Performance Data" section lists the types of testing conducted to support substantial equivalence, rather than specific numerical acceptance criteria.

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

• Biocompatibility Testing: The document states "Test results from a series of in vivo biocompatibility evaluations" but does not specify the sample size for these tests. It indicates the tests were "conducted in accordance with the GLP regulation (21 CFR Part 58) and relevant ISO 10993 series biocompatibility standards." Provenance information (country, retrospective/prospective) is not provided.
• Stability Testing: "Successful stability testing supports the labeled expiration date." No specific sample size, provenance, or detailed methodology is provided.
• Clinical Testing: No clinical testing was performed for the modified devices to establish substantial equivalence. Therefore, there is no sample set, provenance, or type of study to report for clinical trials. The assumption is that the clinical performance of the predicate devices is maintained due to the minor nature of the modification.

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 applicable as the document describes a 510(k) submission for contact lenses, which does not involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI/CAD device would. The "ground truth" for contact lenses is established through well-defined physical, chemical, and biological testing methods against established standards.

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

This information is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are used in studies where human experts are tasked with independently assessing cases, and discrepancies need to be resolved. The testing described here (biocompatibility, stability, material characteristics) does not involve such human-expert adjudication processes.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant to soft contact lenses.

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. The device in question is a physical medical device (contact lens), not an algorithm or AI system.

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

For the specific tests mentioned:

• Biocompatibility: The "ground truth" is established by the results of standardized in vivo (e.g., animal models) and in vitro (e.g., cell cultures) tests based on ISO 10993 standards and measured against predefined toxicity and irritation thresholds.
• Stability: The "ground truth" is established by direct measurement of physical and chemical properties of the lenses over time under various conditions to ensure they meet specifications throughout their shelf-life.
• Technological Characteristics: The "ground truth" is established by direct measurement of physical properties (e.g., refractive index, water content, oxygen permeability, elastic modulus) using validated scientific methods, compared against the known values of the predicate devices and product specifications.

8. The sample size for the training set

This information is not applicable. The submission is for a physical medical device (contact lenses), not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for a contact lens product.

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DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with nondiseased eyes.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES® (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Focus® DAILIES® family and DAILIES® AquaComfort Plus® family are soft contact lenses intended for the optical correction of refractive error. They are available in spherical, toric and multifocal designs.

The DAILIES® lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water. The lens material is considered a Group II contact lens material per 1994 FDA 510(k) guidance document for daily wear contact lenses. The lens material further contains non-functionalized PVA (high- and/or ultra-high molecular weight PVA) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint®) to make the lenses easier to see when handling.

DAILIES® soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top. The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml phosphate-acetate buffered saline solution. The package saline may contain up to 0.05% Poloxamer 108. The package saline of DAILIES® AquaComfort Plus® family lenses additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific "test set" sample size for the modified devices as part of a standalone study directly assessing their primary performance against acceptance criteria in a quantitative manner. Instead, the focus is on a comparison to predicate devices and confirmation of performance through various non-clinical tests.

• Biocompatibility Testing: Conducted on a "series of in vivo biocompatibility evaluations." The specific number of samples or animals used is not detailed, but it was conducted in accordance with GLP regulation (21 CFR Part 58) and relevant ISO 10993 series standards. This implies a standard, but unspecified, number of samples for such tests.
• Stability Testing: Conducted to support the labeled expiration date. The sample size is not specified.
• Clinical Testing: Not required due to the "great similarity of the modified devices to the predicate devices and successful results from nonclinical testing." This means no human clinical test set was used for the modified devices to establish substantial equivalence directly, in terms of primary clinical performance.

Data Provenance: The document implies that the biocompatibility and stability testing data was generated by the manufacturer (Alcon Laboratories, Inc.). There is no mention of country of origin for the data or if it was retrospective or prospective, though in vivo studies are typically prospective.

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

Not applicable. No ground truth in the sense of expert consensus on image interpretation or diagnostic performance was established for a test set, as clinical testing was not deemed necessary for the modified devices. The "ground truth" for the non-clinical tests would be the established scientific and regulatory standards for biocompatibility and stability, as interpreted by the testing labs and regulatory agencies.

4. Adjudication Method:

Not applicable. No adjudication method was mentioned for a clinical test set, as clinical testing was not performed for the modified devices to establish substantial equivalence. For non-clinical tests, reconciliation of results would follow standard laboratory practices and regulatory guidelines, rather than an adjudication method among experts for a diagnostic outcome.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. Clinical testing was explicitly stated as "not required" due to the similarity to predicate devices and successful non-clinical testing. Therefore, there is no effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component of this device.

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 a medical imaging or diagnostic algorithm. Thus, the concept of "standalone" algorithm performance without human-in-the-loop is not relevant. The device itself is the primary product, and "performance" refers to its physical and biological properties.

7. The Type of Ground Truth Used:

The "ground truth" for the assessment of this device is based on:

• Established device specifications and performance characteristics of the predicate devices (e.g., refractive index, light transmittance, oxygen permeability, elastic modulus, water content). The modified devices were compared to these established values.
• Biocompatibility standards: ISO 10993 series and GLP regulations. The "truth" is whether the materials and final product meet these safety standards (e.g., non-cytotoxic, non-irritating).
• Stability standards: The ability to maintain specified performance characteristics over the labeled shelf-life.

This ground truth is primarily based on measured physical and chemical properties, and established regulatory safety standards, rather than expert consensus on a diagnostic outcome or pathology.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device (contact lens), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is established, and design parameters are derived from engineering and material science, not data-driven training.

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

Not applicable, as there is no "training set" for an AI/ML algorithm.

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Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:

Power Range: -20.00 D to +20.00 D
Center Thickness varies with design and power (0.10 mm for -3.00 D spherical)

Lenses have the following properties:

Refractive index: 1.38
Light transmittance: approximately 96 %T
Water content: 69% by weight
Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method)

Lenses are supplied sterile in sealed blister packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other Alcon marketed lens products and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).

This submission (K153643) concerns a modification to Alcon's Focus® DAILIES® family of contact lenses. The modification specifically relates to an "Ink Shelf Life Change" and the use of the same print technology already established for these lenses. The FDA has determined that the modified device is substantially equivalent to the predicate device (K0833216).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met." However, the specific quantitative acceptance criteria for this process validation are not explicitly detailed in the provided text. The reported device performance is that the modified device meets these implicit acceptance criteria, demonstrating equivalence to the predicate.

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

The document explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." This indicates that no new clinical test set with human subjects was used for this specific modification. The validation was primarily based on non-clinical testing (process validation) and comparison to the predicate device's established safety and effectiveness.

• Sample Size (Test Set): Not applicable for human-in-the-loop or standalone clinical testing. For process validation, the sample size would be determined by the validation protocol, but this detail is not provided.
• Data Provenance: Not applicable for a clinical test set in this specific submission. The data provenance would be related to the prior predicate device's studies and in-house process validation data, which are not described in detail here.

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

Not applicable, as no new clinical testing was performed on a test set to establish ground truth in the context of device performance in patients.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical testing was performed involving adjudication of patient outcomes or assessments.

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, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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, not a software algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission relies on the established safety and effectiveness of the predicate device (K083216) and the successful process validation of the modified manufacturing process. The "ground truth" here is that the modified device, due to the ink shelf life change, maintains the same physical and chemical properties and performs equivalently to the previously cleared predicate, thus not adversely altering its safety or effectiveness. This is affirmed by successful process validation and material equivalence.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/machine learning device, there is no "training set" in the conventional sense.

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

Not applicable, for the same reasons as above.

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