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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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Focus® DAILIES® and Focus® DAILIES® Toric (neifilcon 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 eyes.

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 single 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 iens 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 clear or 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 provided document describes the acceptance criteria and the study conducted for the Focus® DAILIES® family of contact lenses (nelfilcon A) to demonstrate substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Focus® DAILIES® lenses were based on demonstrating equivalence to the predicate device (Focus® DAILIES® (nelfilcon A) made without an additive) across key physical/chemical properties and clinical performance. The study aimed to show that lenses made with a manufacturing additive were within established specifications and maintained comparable performance.

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

The document does not explicitly state the numerical sample size for the clinical test set. It mentions "A one-month clinical study". The provenance of the data (country of origin) is not specified. The study appears to be prospective as it's a "one-month clinical study" evaluating the device's performance.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study's evaluation of "vision, health, comfort, and fit." Clinical studies often involve ophthalmologists or optometrists for these assessments, but this is not specified here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices, rather than contact lenses. The study focused on demonstrating equivalence to an existing device rather than human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a contact lens, not a software algorithm. The "performance" refers to the physical and clinical characteristics of the lens itself.

7. Type of Ground Truth Used

The ground truth for the physical and chemical properties was derived from established specifications and validated measurements against those specifications, comparing the new formulation to the predicate device. For the clinical performance, the ground truth was based on clinical evaluation of vision, health, comfort, and fit which would implicitly involve expert (clinician) assessments, but the exact mechanism for establishing "ground truth" (e.g., expert consensus on what constitutes "similar performance") is not detailed.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set in that context. The "training set" for manufacturing would be the established manufacturing processes and quality controls that lead to the "established specifications" mentioned.

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

Not applicable, as it's not an AI/ML device. For contact lens manufacturing, ground truth (or acceptable quality standards) is established through rigorous engineering specifications, material science, and regulatory requirements, which are then validated through extensive testing (physical, chemical, and clinical).

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