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AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

AIR OPTIX® COLORS Toric (Iotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with 6.00 diopters (D) or less of astigmatism.

AIR OPTIX® COLORS Multifocal (Iotraficon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and/or presbyonia in phakic or aphakic persons with non-diseased eves 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.

AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.

The lenses may be prescribed for frequent wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group V (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2006/Amd.1:2009. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: iron oxides, titanium dioxide, [phthalocyaninato (2-)] copper, and phthalocyanine green.

Lens designs for AIR OPTIX® COLORS (lotrafilcon B) lenses include spherical, toric, and multifocal lenses in the following parameter range:

Power Range: -20.00D to +20.00D
Center Thickness: varies with design and power (0.08 mm for -3.00D spherical)
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm

Lenses have the following properties:

Refractive index: 1.422 (hydrated)
Light transmittance: > 95% (380 - 780 nm)
Water content: 33% by weight in normal saline
Oxygen permeability: 110 x 10 -11 (cm2/sec)(ml O2/ml x mm Hg), measured at 35°C (intrinsic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845 (labeled as buffered saline containing 0.2 % VP/DMAEMA Copolymer).

The provided document describes the K133176 510(k) submission for AIR OPTIX® COLORS (lotrafilcon B) Contact Lenses. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission, the acceptance criteria are not explicitly stated as numerical thresholds for specific performance metrics in the provided text. Instead, the study aims to demonstrate "substantial equivalence" to the predicate device, AIR OPTIX® AQUA.

The reported device performance for AIR OPTIX® COLORS is compared implicitly through the conclusion of substantial equivalence.

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

• Sample Size: A total of 147 subjects were enrolled and randomized in the clinical study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It was a prospective study, indicated by the description "3-month prospective, randomized, controlled, open-label, parallel-group, multi-center study."

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

The document does not describe the establishment of a "ground truth" in the sense of expert consensus on specific visual outcomes or physiological findings for each subject. Instead, the study relies on the performance of the lenses as observed and measured by the "eye care professional" and reported by the subjects. There is no mention of a ground truth panel of experts evaluating the test set.

4. Adjudication Method (for the test set)

No adjudication method is described for the test set. The clinical study seems to have collected data directly from subjects and clinicians without an independent adjudication process for critical endpoints.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens, and the study evaluated its clinical performance directly, not an AI system assisting human readers.

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

A standalone performance study was not done. This device is a contact lens and does not involve an algorithm to be tested in a "standalone" fashion.

7. The Type of Ground Truth Used

The "ground truth" for this study is the clinical and physiological response of human subjects wearing the contact lenses, as measured by visual acuity, biomicroscopy, subjective assessments (comfort, vision, handling), and reported adverse events. For non-clinical aspects, the ground truth relates to established physical properties (refractive index, Dk, water content) and safety standards (biocompatibility, non-toxicity).

8. The Sample Size for the Training Set

There is no mention of a training set as this is a medical device (contact lens) and not an AI/algorithm-based product requiring a training set in the conventional sense. The "training" for the device would have been its manufacturing development and quality control processes.

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

Not applicable, as there is no training set in the context of an AI/algorithm. For the manufacturing of the lenses, the "ground truth" for quality and performance would be established through internal specifications, quality control, and adherence to recognized standards for contact lens materials and manufacturing. This information is not detailed in the provided summary.

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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 notaphakic 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.

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.

The lens material is 69% water and 31% nelficon A polymer (polyvinyl 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: -20.00D to +20.00D, Center Thickness: varies with design and power (0.10 mm for -3.00D spherical).

Lenses have the following properties: Refractive index: 1.38, Light transmittance: ≥ 92% (@ 610 nm), 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 provided document, a 510(k) Summary for Nelfilcon A Soft Contact Lenses (K123994), primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds for safety or effectiveness for the modified device. Instead, it relies on demonstrating that the modified device's characteristics are substantially equivalent to established predicate devices. The "performance" reported is therefore a comparative one against these predicates.

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."

Therefore:

• Sample size for test set: Not applicable (no clinical test set used for the modified device).
• Data provenance: Not applicable (no clinical data for the modified device). The documentation relies on the established safety and effectiveness of the predicate devices and non-clinical bench testing.

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

Not applicable, as no clinical testing was performed for the modified device. The "ground truth" for demonstrating substantial equivalence was derived from the established safety and performance of the predicate devices and the results of non-clinical, bench-top testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing was performed for the modified device.

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-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this medical 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.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission stemmed from:

• Substantial Equivalence to Predicate Devices: The primary "ground truth" is the established safety and effectiveness of the legally marketed predicate devices (DAILIES® AquaComfort Plus® - K072777, and FOCUS® DAILIES® - K083216). The modified device is considered safe and effective because it is fundamentally the same as these already cleared devices, with a minor modification (integrated print step from one predicate applied to the other family) that is not deemed to adversely affect safety or effectiveness.
• Non-clinical Bench Testing: Physicochemical characteristics, biocompatibility (non-toxicity, non-irritation), and stability testing were performed to confirm that the modified device's properties were substantially equivalent to the predicate and supported the labeled expiration date.

8. The Sample Size for the Training Set

Not applicable, as this is a contact lens and not an algorithm requiring a training set.

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

Not applicable, as this is a contact lens and not an algorithm requiring a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a demonstration of substantial equivalence through comparative analysis and non-clinical testing, rather than a clinical trial with acceptance criteria for a novel device.

• Rationale: The modification (applying an existing print technology from one predicate contact lens family to another closely related contact lens family) was considered minor enough that new clinical data was not required.
• Evidence:
  • Comparative Table (Table 1): Detail-by-detail comparison of the modified device's characteristics against two predicate devices, showing that most parameters are identical or have differences (like the specific manufacturing step for integrated print or minor saline solution variations) that are justified as not impacting safety or effectiveness.
  • Non-clinical Testing: Biocompatibility testing (in accordance with GLP regulation 21 CFR Part 58) confirmed the material was non-toxic and non-irritating. Physicochemical characteristics were verified as substantially equivalent. Stability testing supported the labeled expiration date.

The conclusion is that the DAILIES® AquaComfort Plus® family of lenses (with the integrated print step) is substantially equivalent to its predicate lenses and other similar daily wear soft contact lenses, and any existing differences "do not adversely affect the safety and effectiveness of the device."

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DAILIES TOTAL 1® (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism.

DAILIES TOTAL 1® (delefilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less 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 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.

DAILIES TOTAL 1® (delefilcon A) multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of astigmatism and who may require a reading addition of +3.00 diopters (D) or less.

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 33% water and 67% delefilcon A, a silicone containing hydrogel with added phosphatidylcholine. The core lens material containing 33% water transitions through a water gradient to a hydrogel surface layer that exceeds 80% water. Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

Delefilcon A lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm
Power Range: -20.00D to +20.00D
Center Thickness: varies with design and power (0.09 mm for -3.00D spherical)

Lenses have the following properties:
Refractive index: 1.42 (hydrated)
Light transmittance: ≥ 93% (@610 nm, -1.00D)
Water content: 33% by weight in normal saline
Surface water content: ≥ 80%
Oxygen permeability: 140 x 10-11 [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)

Each lens is packaged in a foil-sealed plastic containing phosphate buffered saline solution with approximately 0.3% of polymeric wetting agents consisting of copolymers of polyamidoamine and poly(acrylamide-acrylic acid) and are steam sterilized.

Here's an analysis of the provided text regarding the Delefilcon A Soft Contact Lenses (DAILIES TOTAL1®) K113168 submission, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for contact lenses primarily focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific numerical performance acceptance criteria in the same way a diagnostic algorithm might. The core "acceptance criteria" here are defined by the predicate device's properties and established safety/efficacy.

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

• Test Set Sample Size:
  • Clinical Study: 60 subjects for the Delefilcon A (test) lenses and 30 subjects for the Narafilcon B (control) lenses. (Total: 90 subjects)
  • Non-clinical Testing: The text does not specify sample sizes for non-clinical tests (e.g., in vitro material testing, biocompatibility).
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was conducted retrospectively or prospectively. However, the description "a three-month clinical study was conducted" and "prospective, randomized, parallel group design" strongly indicates a prospective study. The submitter, CIBA VISION Corporation, is based in Duluth, Georgia, USA, suggesting the study likely took place in the US or under US regulatory oversight.

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

This type of information is generally not applicable to a contact lens submission, as "ground truth" in the context of diagnostic AI/ML is typically established by expert consensus on image interpretation or pathology.

For contact lenses, the "ground truth" for efficacy and safety variables like visual acuity, biomicroscopy findings, and subjective ratings (comfort, vision, handling) is established through standardized clinical examination procedures performed by qualified investigators and ophthalmologists/optometrists who conduct the clinical trial. Their qualifications are assumed to be appropriate for conducting clinical trials involving contact lenses. The number of such experts involved is not specified but would include the clinical investigators and potentially a data safety monitoring board.

4. Adjudication Method (for the test set)

The document mentions "biomicroscopy findings" as a primary safety variable and "visual acuity" as a primary efficacy variable. For these objective measurements, adjudication in the sense of expert consensus on ambiguous cases (as in image interpretation) is generally not performed. Measurements are typically taken by trained clinical personnel. Subjective ratings (vision, comfort, handling) are self-reported by the subjects. There is no indication of an adjudication method described for the clinical trial data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a soft contact lens, not an AI/ML-driven diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not performed. The clinical study performed was a direct comparison of the new lens to a predicate lens.

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

This is not applicable. The device is a physical medical device (contact lens), not an algorithm. So a standalone algorithm performance study was not done.

7. The Type of Ground Truth Used

For the clinical study:

• Safety: Established through biomicroscopy findings (objective clinical assessment of eye health by investigators) and observation of adverse events.
• Efficacy: Established through visual acuity measurements (objective assessment) and refraction/keratometry (objective measurements).
• Patient Experience: Established through subjective ratings of vision, comfort, and handling (patient-reported outcomes).

For the non-clinical testing:

• Material Properties: Established through standardized laboratory testing (e.g., refractive index measurements, water content testing, oxygen permeability Dk measurement).
• Biocompatibility: Established through GLP-compliant (21 CFR Part 58) non-clinical biocompatibility testing as per established industry standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device (contact lens), not an AI/ML algorithm that requires a "training set."

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

This is not applicable, as there is no training set for a contact lens device.

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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 (polyvinyl 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.

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:

• Power Range: -20.00D to +20.00D .
• 0.010 mm for -3.00D spherical (varies with power) Center Thickness: .

Lenses have the following properties:

• 1.38 Refractive index: .
• 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 CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack 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). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a contact lens seeking substantial equivalence through a 510(k) submission. For such devices, acceptance criteria are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. The primary "performance" metric here is the demonstration of substantial equivalence.

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."

Therefore:

• Sample Size for Test Set: Not applicable, as no new clinical testing was performed for this 510(k) submission.
• Data Provenance: Not applicable.

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

Not applicable, as no new clinical (test set) data was generated or evaluated for this 510(k) submission. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical (test set) data requiring adjudication was generated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No. This is a medical device (contact lens) and not an AI/software device that would typically undergo MRMC studies. The approval pathway is 510(k) where "substantial equivalence" to a predicate is the primary criterion.

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

No. This is a contact lens, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the safety and effectiveness established for the predicate devices. This would have been determined through:

• Clinical Performance: Data from human clinical trials (implied to have been conducted for the original predicates).
• Physical and Chemical Properties: Bench testing data comparing material characteristics.
• Toxicological Testing: Data supporting biocompatibility.
• Stability Testing: Data demonstrating shelf life and sterility maintenance.

For the current submission, the ground truth is essentially the established regulatory status and performance of the predicate lenses.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm was involved. If "training set" refers to the data used to initially establish the safety and effectiveness of the predicate devices, that information is not provided in this 510(k) summary.

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

Not applicable, as this is a contact lens and not an AI/software device with a "training set." The safety and effectiveness of the predicate devices were established through a combination of non-clinical (material properties, sterilization, packaging integrity, stability) and clinical testing, as is standard for contact lenses. The present submission leverages that established "ground truth" of the predicate devices to demonstrate substantial equivalence for the modified device.

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CIBA VISION® (lotrafilcon B) 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 and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

CIBA VISION® Toric (lotrafilcon B) 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 6.00 diopters (D) or less of astigmatism.

CIBA VISION® Multifocal (lotrafilcon B) 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.

CIBA VISION® Multifocal Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of refractive and/or corneal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

CIBA VISION® spherical (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

CIBA VISION® toric (lotrafilcon A) 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 10.00 diopters (D) or less of astigmatism.

CIBA VISION® multifocal (lotrafilcon A) 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.

CIBA VISION® multifocal toric (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

In addition, CIBA VISION® (lotrafilcon A) lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during healing if required.

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lenses contain the color additive phathalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.

Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges:
• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
• Center Thickness: varies with design and power (0.08 mm for -3.00D spherical)

Lenses have the following properties:

• Refractive index: 1.4217 (hydrated)
• Light transmittance: > 94 %
• Water content : 33% by weight in normal saline
• Oxygen permeability [(cm2 /sec)(ml O2 /ml.mmHg)} measured at 35°C (intrinsic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845.

The lens material is 24% water and 76% lotrafilcon A, a fluoro-silicone containing hydrogel which is surface treated. Lenses may be clear or contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.

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

• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
• Center Thickness: varies with power (0.080 mm for -3.00D spherical)

Lenses have the following properties:

• Refractive index: 1.4271 (hydrated)
• Light transmittance: > 94 %
• Water content : 24% by weight in normal saline
• Oxygen permeability [(cm2 /sec)(ml O2 /ml.mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845.

The provided text describes Lotrafilcon B and Lotrafilcon A Soft Contact Lenses. The "acceptance criteria" discussed are primarily tied to demonstrating substantial equivalence to predicate devices through non-clinical testing. This is not a study proving a device meets specific performance criteria in the way a clinical trial for a diagnostic AI might, but rather demonstrating that a modified version of an already approved device maintains its safety and effectiveness.

Here's an attempt to structure the information based on your request, understanding that the nature of this submission (510(k) for contact lenses) is primarily about equivalence rather than novel AI performance.

Acceptance Criteria and Study for Lotrafilcon B and Lotrafilcon A Soft Contact Lenses

The primary acceptance criterion for the Lotrafilcon B and Lotrafilcon A soft contact lenses, as described in these 510(k) summaries, is Substantial Equivalence to their respective predicate devices. This means that the modified devices (lenses packaged with saline additive) must demonstrate that they are as safe and effective as the previously cleared versions.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of individual patient data or image datasets with sample sizes. The testing largely involved non-clinical laboratory evaluations of the device materials and properties.

• Sample Size for Test Set: Not applicable in the context of individual patient data; refers to materials testing.
• Data Provenance: The studies were non-clinical, conducted in accordance with regulations like GLP (Good Laboratory Practice) (21 CFR Part 58). Based on the submitter information, CIBA VISION Corporation is located in Duluth, Georgia, USA, implying testing was likely conducted in the USA or supervised according to US regulations. The studies are by nature prospective (i.e., conducted for the purpose of this submission).

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

This information is not explicitly provided. For "ground truth" in non-clinical materials testing, it would typically be established by laboratory standards and validated analytical methods, not by human experts adjudicating individual cases.

4. Adjudication Method for the Test Set

Not applicable. The testing was non-clinical and involved laboratory analyses and measurements of material properties against established standards and comparison to a predicate device, rather than subjective evaluation requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. These are contact lenses, not a diagnostic AI device requiring human reader performance evaluation.

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

This refers to the performance of an AI algorithm, which is not applicable here as the device is a physical medical device (contact lenses), not an AI/software device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

• Established standards and validated analytical methods for material properties (e.g., Dk, water content, refractive index, light transmittance).
• Biocompatibility testing guidelines (e.g., ISO 10993 series, implicitly followed by GLP compliance) to determine toxicity and irritation.
• Comparison to the known properties and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set for an AI model.

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CIBA Vision® (nelfilcon A) Spherical and Toric 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.

CIBA Vision® (nelfilcon A) Progressives 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 nelfilcon A lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyaninks (UD).

Nelfilcon A lens designs currently include spherical, toric, and multifocal in the following parameter ranges:
Power Range: -20.00D to +20.00D
Center Thickness: 0.010 mm for -3.00D spherical (varies with power)

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.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Nelfilcon A Soft Contact Lenses for Daily Wear

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "Substantial Equivalence" as the primary acceptance criterion, meaning the device must perform comparably to a predicate device. Specific quantitative acceptance criteria are not explicitly detailed in threshold values (e.g., "must achieve X% vision improvement"). Instead, the performance is described relative to the predicate device and established standards for contact lenses.

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

• Sample Size: Not explicitly stated. The document mentions "a clinical study" and "an investigation" but does not provide the number of subjects or eyes included in the clinical test set.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "daily disposable wear investigation." The document implies that the study was prospective, as it "investigated" the lens and was performed to "demonstrate" substantial equivalence.

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

This information is not provided in the document. For contact lens studies demonstrating substantial equivalence, "ground truth" often refers to clinical assessments by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed here.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study, as typically understood in AI/medical imaging, was not performed. The study compared the device's clinical performance to an "FDA cleared and commercially available contact lens" (the control/predicate), but this is a direct clinical comparison, not a study of human readers improving with AI assistance. The device itself is a contact lens, not an AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A (Not Applicable). The device is a physical medical device (contact lens), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The "standalone" performance would be the lens's inherent physical and optical properties, which were part of the non-clinical testing.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established physical and material property measurements, and standard biocompatibility assays. For clinical testing, the "ground truth" was established through clinical assessments by medical professionals comparing the performance of the CIBA Vision® (nelfilcon A) lens to a control lens in terms of vision, health, comfort, and fit. This type of ground truth is based on expert clinical observation and evaluation, not pathology or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

N/A (Not Applicable). The device is a physical contact lens, not an AI system or algorithm that requires a training set.

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

N/A (Not Applicable), as there is no training set for a physical contact lens device.

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CIBA Vision® (sifilcon 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 who have 1.50 diopters or less of astigmatism.

CIBA Vision® Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 10.00 diopters (D) or less of astigmatism.

CIBA Vision® Multifocal (sifilcon A) 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 +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism.

CIBA Vision® Multifocal Toric (sifilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and have 4.00 diopters (D) or less of astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eve care professional.

The lens material is 32% water and 68% sifilcon A a fluoro-silicone containing hydrogel which is surface treated.

Sifilcon B lens designs include spherical, toric, multifocal and multifocal toric in the following parameter ranges:
Diameter Range: 12.0 to 15.0 mm
Base Curve Range: 7.0 to 9.2 mm
Power Range: -20.00D to +20.00D
Center Thickness: 0.070 mm for -3.00D spherical (varies with power)

Lenses contain the color additive Phthalocyanine Green (PCN Green), a light green handling tint, which makes them easier to see when handling.

Lenses have the following properties:
Refractive index: 1.43 (hydrated)
Light transmittance: approximately 92 %
Water content : 32% by weight in normal saline
Oxygen permeability: 82 x 10 -11 [(cm2 /sec)(ml O2 /ml=mmHg)] measured at 35°C (intrinsic Dk-Polarographic method)

Lenses are supplied sterile in sealed blister-packs containing isotonic phosphate buffered saline solution.

The provided document describes the safety and substantial equivalence of CIBA Vision's Sifilcon A Soft Contact Lenses for Daily Wear (K062262) to a previously cleared predicate device (Lotrafilcon B).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative table for clinical performance. Instead, it describes demonstrating "similar overall performance" to the predicate in key areas. For non-clinical, it uses terms like "consistent with or better than" and "substantially equivalent."

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

• Test Set Sample Size: The document mentions a "daily wear clinical study" but does not specify the sample size for this clinical evaluation.
• Data Provenance: The clinical study was conducted in accordance with current Good Clinical Practices (GCP) and published regulations (21 CFR Parts 50, 56, 312, and 812). It compares the sifilcon A lens to an "FDA approved and commercially available contact lens." The country of origin for the data is not explicitly stated, but given FDA submission, it's highly likely to be within the USA or a region adhering to similar regulatory standards for clinical trials. The study is a prospective clinical investigation.

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

• Number of Experts & Qualifications: The document does not specify the number of experts or their qualifications used to establish ground truth in the clinical study. It implies that "eye care professionals" would recommend the lenses for daily wear, but this is about prescription, not ground truth establishment for the study itself. Clinical studies for contact lenses typically involve ophthalmologists or optometrists assessing patient outcomes, but specific details are absent.

4. Adjudication Method for the Test Set:

• Adjudication Method: The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

• MRMC Study: This is not applicable as the device is a medical product (contact lens), not an AI or imaging diagnostic tool that would typically involve multiple readers interpreting cases. The clinical study was a comparison of device performance between two contact lens types.
• Effect Size: No effect size in terms of human reader improvement with/without AI assistance is mentioned or relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance: This is not applicable as the device is a contact lens, not a computational algorithm. The evaluation focuses on the performance of the physical lens as used by human wearers.

7. The Type of Ground Truth Used:

• Type of Ground Truth: For the clinical testing, the "ground truth" would be established by direct clinical observations and measurements of patient outcomes (e.g., vision, lens fit, comfort, ocular health assessments) performed by qualified medical professionals (e.g., ophthalmologists, optometrists). For non-clinical testing, it would be based on validated laboratory measurements and biocompatibility assessments.

8. The Sample Size for the Training Set:

• Training Set Sample Size: The concept of a "training set" is not applicable to this type of device (contact lens). There is no machine learning model being trained. The "training" for the device would be the manufacturing process and quality control.

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

• Ground Truth for Training Set: As there is no training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and manufacturing would be established through material specifications, engineering design principles, and quality control standards.

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The ProGuard™ Lens Case is indicated for storage of soft (hydrophilic) contact lenses with AQuify® Multipurpose Solution.

Data indicate that lens cases are a significant source of microbial contamination. The ProGuard Lens Case is a contact lens storage case that is infused with silver to help minimize contamination on the lens case surface. Laboratory testing showed that the silver ions reduce bacterial growth of Pseudomonas aeruginosa and Citrobacter amalonaticus on the case surface after 24 hours. No significant reduction was observed in the ProGuard lens case with S.epidermidis, S. aureus, P. mirabilis and S. marcescens (2 isolates).

The provided text describes the "ProGuard Lens Case" and its performance in various studies. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" isn't explicitly defined with numerical thresholds in the document. Instead, the studies aim to demonstrate "substantial equivalence" to a predicate device and "significant reduction" in bacterial contamination. Based on the reported findings, here's a table summarizing the performance:

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

• Direct Microbial Challenge Studies:

  • Sample Size:
    • 8 bacteria isolates were tested.
    • ProGuard lens cases and "regular lens cases" were exposed, but the exact number of cases per group isn't specified (e.g., how many ProGuard cases vs. how many regular cases were used for each isolate).
  • Data Provenance: Retrospective (laboratory testing). No country of origin is specified, but given the submitter's location (Georgia, USA), it's likely U.S. based.

• Clinical Study #1:

  • Sample Size: 39 subjects. Each subject used one ProGuard bowl and one control case bowl.
  • Data Provenance: Prospective (one-month clinical trial). No country of origin is specified, but again, likely U.S. based due to the submitter.

• Clinical Study #2:

  • Sample Size: 40 subjects. Each subject used one ProGuard bowl and one control lens case bowl.
  • Data Provenance: Prospective (one-month clinical trial). No country of origin is specified, but likely U.S. based.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets.

• For the microbiology studies, ground truth was established by laboratory methods (culturing and counting bacteria), not by human expert opinion.
• For the biocompatibility studies, ground truth was established by standardized tests (USP, ISO) with measurable endpoints (e.g., reactivity grade, ocular scores) which typically don't involve subjective expert consensus for "ground truth."
• For the clinical studies, the "ground truth" was the measured bacterial contamination level determined by laboratory analysis of the collected cases, not by expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method for the test set.

• The studies described rely on objective laboratory measurements (bacterial counts, silver concentration, reactivity grades, ocular scores) or statistical comparisons of these measurements. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., imaging studies where multiple readers interpret images and a tie-breaker is needed).

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

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC for AI assistance) is not relevant to this device, which is a contact lens case, not an AI-powered diagnostic or interpretive tool. There is no AI component involved, nor are human readers interpreting data.

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

This question is not applicable as the device (ProGuard Lens Case) is a physical medical device, not an algorithm. Therefore, there is no "standalone algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used in these studies varied by the type of non-clinical and clinical evaluation:

• Microbiology Studies (Direct Challenge & Clinical):
  • Bacterial Counts/Contamination Levels: Determined by laboratory methods (culturing, enumeration), which is a form of laboratory-confirmed outcome or direct measurement.
• Biocompatibility Studies (Cytotoxicity, Ocular Irritation, Systemic Toxicity):
  • Standardized Test Results: Based on established protocols like USP and ISO, yielding objective measurements like Reactivity Grade, Ocular Scores, and observations of systemic toxicity. This is a form of objective measurement against established standards.
• Silver Determination:
  • Concentration Measurement: Determined by Atomic Absorption (AA) spectroscopy, which is a direct analytical measurement.

8. The Sample Size for the Training Set

Not Applicable. The ProGuard Lens Case is a physical medical device. It is not an AI algorithm that requires a "training set" in the machine learning sense. The testing performed involved demonstrating safety and effectiveness directly through non-clinical and clinical studies, not by training a model.

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

Not Applicable (as explained in point 8).

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AQuify® Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify is also indicated for daily protein removal when lenses are soaked for at least 4 hours.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called Aquify® Multipurpose Solution. This document is related to regulatory approval for a contact lens care product and does not contain information about the performance of an AI/ML powered device, its acceptance criteria, or any associated studies.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.

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Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) ONE-DAY 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 eves.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of 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. DAILIES lenses are not intended to be cleaned or disinfected and should be discarded after a sinqle use.

The Focus® DAILIES®, Focus® DAILIES® Toric and Focus® DAILIES® Progressives (nelfilcon A) ONE-DAY CONTACT LENS are daily wear soft contact lenses intended for single use daily disposable wear. The Dailies lens is a spherical soft contact, Dailies toric lenses have a double thin zone design, and the Dailies Progressives lens is a progressive aspheric simultaneous vision soft contact lens. A constant near power profile is incorporated into each Progressive lens across the full range of distance powers. The near and intermediate powers are concentrated primarily in the central portion of the optical zone while the surrounding portion is weighted toward distance. The continuous changes in power across the surface of the lens allow patients requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances.

The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP).

Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphateacetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.

The physical properties of the lens are:

• Refractive Index: 1.38 (hydrated)
• Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00D; 0.15 at +3.00D)
• Light Transmittance: 96% (approx)
• Oxygen Permeability (Dk): [35° C, Fatt corrected] 26 x 10-11 (cm²/sec) (ml O2/ml x mm Hg)
• Water Content: 69% by weight in normal saline

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CIBA Vision Focus® DAILIES® contact lenses:

Overview:

This 510(k) summary for K050065 focuses on demonstrating substantial equivalence of Focus® DAILIES® contact lenses (spherical, toric, and progressives) made with an additional manufacturing additive, to previously cleared predicate devices. The study detailed is not a traditional "device performance" study in the sense of accuracy metrics for a diagnostic device, but rather a demonstration of comparability and safety for a modified medical device (contact lenses).

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the equivalence of the modified device to the predicate rather than defining specific acceptance criteria for a novel device performance. The "acceptance criteria" here are implied to be that the properties and performance of the new lenses are within the established specifications and clinical performance expectations of the predicate device.

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

• Sample Size (Clinical Testing): Not explicitly stated. The document only mentions "Clinical studies."
• Data Provenance: Not explicitly stated. It refers to "Clinical studies," but doesn't specify if they were retrospective or prospective, or the country of origin of the data. Given it's a 510(k) in the US, it's highly likely the studies were conducted to US regulatory standards, implying a prospective nature, but this is an inference.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for contact lenses in such a submission isn't typically established by expert consensus on discrete findings in the same way it would be for a diagnostic image analysis algorithm. Instead, it relies on clinical outcomes measured by and reported by investigators.

4. Adjudication Method for the Test Set:

Not applicable. The study described is a clinical trial comparing device performance, not an expert review of a test set where adjudication would be necessary.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images. This submission is for contact lenses, which are a therapeutic and vision correction device, not a diagnostic one.

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

Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" for the clinical study would be:

• Refractive Correction: Measured visual acuity and refractive error.
• Ocular Health: Clinical examination findings by an ophthalmologist or optometrist (e.g., slit lamp examination for corneal health, conjunctival hyperemia).
• Comfort and Fit: Patient-reported outcomes and clinician assessment of lens fit on the eye.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing would be the established manufacturing processes and quality control, not a data-driven training set.

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

Not applicable, as there is no training set in the AI/ML sense. For manufacturing and material science, the "ground truth" for establishing specifications would be derived from:

• Industry standards.
• Pre-existing knowledge of the material properties.
• Extensive testing during product development and validation against established safety and performance benchmarks for contact lenses.
• Regulatory requirements.

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