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Alcon (serafilcon 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 up to approximately 1.50 diopters of astignatism that does not interfere with visual acuity.

Alcon for Astigmatism (serafileon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism.

Alcon Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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 that does not interfere with visual acuity.

Alcon Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia) 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 6.00 diopters (D) of astigmatism.

The lenses are to be prescribed for daily wear with removal for disposal, or cleaning and heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded with a new pair each week, or more often, if recommended by the eye care professional.

The subject device is made from a silicone containing hydrogel lens material that is approximately 55% water and 45% serafilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edge-to-edge color to make it easier to see when handling. In addition, lenses contain two benzotriazole monomers to block UVA and UVB radiation, and additionally, reduce transmittance in the range of 380 nm to 450 nm.

Serafilcon A represents a Group 5B silicone hydrogel contact lens material ('enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications.

Serafilcon A lens designs include spherical, toric, multifocal toric 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: -20.00 D to +20.00 D
• Center Thickness: varies with design and power (Example: 0.08 mm for -3.00 D spherical)
• Cylinder Power (toric) Range: -0.25 D to -10.00 D
• Cylinder Axis (toric) Range: 001 to 180°
• ADD Power (multifocal) Range: LO, MED, HI

Lenses have the following properties:

• Refractive index: 1.40 (hydrated)
• Water content : 55% by weight in normal saline
• Oxygen permeability: 119 x 10 -11 [(cm2 /sec)(ml O2 /mlommHg)] measured at 35 °C (normalized Dk-Polarographic method)
• Light transmittance: ≥85%
• UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 nm for the entire power range.

Serafilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents.

The provided text describes the Alcon™ contact lenses and their substantial equivalence to a predicate device, CooperVision Biofinity (comfilcon A) soft contact lens. However, the text details the testing performed to demonstrate safety and performance for the contact lenses themselves, not the acceptance criteria and performance of an "AI/algorithm device" as implied by the structure of the request.

Therefore, I cannot extract the information required for the requested table and study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth, training set size, and training ground truth establishment) because the document does not concern an AI/algorithm device.

The document discusses the following:

• Device Name: Alcon™, Alcon™ for Astigmatism, Alcon™ Multifocal, Alcon™ Multifocal Toric (serafilcon A) soft contact lenses
• Predicate Device: CooperVision Biofinity (comfilcon A) soft contact lens
• Performance Data: A series of nonclinical tests (biocompatibility, physical-chemical, solution compatibility, sterilization, and stability) and a clinical study were performed to demonstrate substantial equivalence.
• Clinical Study Details:
  • Design: Prospective, randomized, stratified, controlled, double-masked, parallel group study.
  • Study Sites: Eight (8) sites in the US.
  • Subjects Enrolled: 120 subjects (240 eyes), with 119 randomized and exposed, and 110 completing the study.
  • Ratio: 2:1 ratio of test (serafilcon A, 78 subjects) to control (comfilcon A, 41 subjects).
  • Wear Modality: Daily wear for approximately 3 months.
  • Replacement Schedule: Test lenses replaced weekly, control lenses monthly.
  • Primary Effectiveness Endpoint: Study lens visual acuity at distance.
  • Other Assessments: Refraction, keratometry, lens fit, surface characteristics, subjective ratings of vision, comfort, and handling.
  • Conclusion: The study showed similar clinical performance between test and control lenses in vision, comfort, fit, handling, and health, demonstrating substantial equivalence.

Since the request is specifically for an algorithm/AI device, and the provided text is about contact lenses, I am unable to fulfill the request as stated.

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DAILIES® Colors (nelfilcon A) One-Day Contact Lenses with refractive power, are indicated for the optical correction of refractive ametropia (myopia, hyperopia ) in not-aphakic persons with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® Colors Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily disposable 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® Colors Progressives (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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® Colors (nelfilcon A) One-Day Contact Lenses (with or without corrective power) also act to enhance or alter the apparent color of the eye.

DAILIES® Colors (nelfilcon A) One-Day Contact Lenses are to be prescribed for single-use daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The subject device, DAILIES Colors contact lenses, are a modification of the currently commercialized FreshLook® One-Day (nelfilcon A) color contact lenses. DAILIES Colors are soft contact lenses intended for the optical correction of refractive error, and the enhancement or alteration of the apparent color of the eye. Geometries include spherical, toric, and multifocal lens designs.

DAILIES Colors lenses are composed of nelfilcon A, which is a non-ionic, hydrophilic lens material, that consists of approximately 69% water and 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are pad printed with intermittent ink layers containing a combination of the following color additives, approved for use in color contact lenses: chromium oxide, iron oxides, [phthalocyaninato (2- )] copper, phthalocyanine green, and titanium dioxide.

Lens designs for DAILIES Colors (nelfilcon A) lenses include spherical, toric, and multifocal lenses in the following parameter range:
• 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 (0.100 mm for -3.00D spherical)

Lenses have the following properties:
• Refractive index: 1.38 (hydrated)
• Water content: 69% by weight in normal saline
• Oxygen permeability 26 barrer units at 35 °C (Fatt corrected)
• % Light transmittance > 88% (average over 380-780 nm)

Lenses are provided in sterile packages of foil-sealed blister-packs containing buffered saline.

The provided text is a 510(k) summary for new contact lenses. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through an independent study with a test set, ground truth, and expert evaluation in the way a diagnostic AI device would.

Therefore, the information required to answer the prompt directly, such as acceptance criteria for performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for diverse test sets, establishment of ground truth by multiple experts, and comparative effectiveness studies, is not present in this document.

This document states that the scope of the device modification did not necessitate clinical testing and instead relies on non-clinical testing (biocompatibility and process validation) to verify equivalence to the predicate device.

However, I can extract what is provided regarding the "acceptance criteria" and "device performance" within the context of this 510(k) summary:

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion here is substantial equivalence to the predicate device, FreshLook® One-Day (nelfilcon A) color contact lenses (K050213, K180398, K180669). This is demonstrated by showing that the modified device (DAILIES® Colors) has:
  • The same material properties (Nelfilcon A, 69% water content, 26 barrer oxygen permeability, 1.38 refractive index, >88% light transmittance).
  • The same manufacturing method (Lightstream Technology: Full mold cast, integrated print step).
  • The same sterilization method (Steam sterilization).
  • The same packaging (Blister pack) and storage solution.
  • The same intended use and indications for use.
  • Successful biocompatibility testing and process validation (implicitly meeting established safety standards for contact lenses, which are the acceptance criteria for these tests).
  • Clinical performance similar to the predicate device (implied by not requiring new clinical testing due to the nature of the modification).

Since the document explicitly states that clinical testing was not necessitated due to the nature of the modification (an altered print pattern), the concepts of a test set, expert-established ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

Here's how I can address the prompts based only on the provided text, noting where information is absent:

Acceptance Criteria and Device Performance for DAILIES® Colors Contact Lenses

Given that this 510(k) summary is for a medical device (contact lenses) and not a diagnostic AI/algorithm, the "acceptance criteria" and "device performance" are framed around demonstrating substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

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

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

• Sample Size for Test Set: Not applicable in the context of diagnostic performance testing. The "testing" referred to is biocompatibility and manufacturing process validation. Sample sizes for these types of engineering/chemistry tests are typically determined by relevant ISO standards or internal quality protocols, and are not detailed in this summary.
• Data Provenance: Not applicable in the context of diagnostic performance testing. The tests are non-clinical (biocompatibility, process validation) and are implicitly performed by/for the manufacturer (Alcon Laboratories, Inc., Fort Worth, TX).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This submission does not involve diagnostic ground truth establishment by experts for image interpretation or similar tasks. Biocompatibility testing follows established lab protocols and standards, and process validation is an engineering/manufacturing assessment.

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

• Not applicable. No adjudication method for a "test set" in the diagnostic sense is mentioned or implied.

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. This is not a study of AI assistance for human readers. The document explicitly states: "The scope of the device modification did not necessitate clinical testing, in order to establish safety or efficacy."

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

• No. This is not a submission for an algorithm or AI.

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

• Not applicable. For this type of device, "ground truth" relates to material specifications (chemical composition, physical properties), manufacturing process parameters, and standard biocompatibility assay results. These are established through validated laboratory tests and engineering specifications, not expert consensus on clinical cases or pathology.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. (See answer to #8).

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DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon 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 up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1 for ASTIGMATISM (delefilcon 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 up to 6.00 diopters (D) of astigmatism.

DAILIES TOTAL1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) 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 (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, hyperopia) 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 6.00 diopters (D) of astigmatism.

The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The DAILIES TOTAL 1® family of daily disposable soft contact lenses are made from delefilcon A, a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. The delefilcon A silicone hydrogel material is considered a Group 5C material according to ISO 18369-1:2017 (defined as: "enhanced oxygen permeable material", water content less than 50%, no ionic monomer or oligomer at pH 6 to pH 8).

Modified DAILIES TOTAL1® lenses contain a combination of light absorbing chromophores. Specifically, benzotriazole UV absorbing monomers are used to block UV radiation and, additionally, reduce transmittance in the range from 380 nm. The color additive [phthalocyaninato (2-)] copper (synonym: copper phthalocyanine) provides a light blue-green handling tint.

Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric lenses in the following parameter range:

• 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)
• Water content: 33% by weight in normal saline
• Oxygen permeability 140 barrer units measured at 35 °C (intrinsic Dk - Coulometric method)
• % Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm)
• % UV transmittance UVA (315-380 nm):

The provided text describes modifications to already cleared contact lenses (DAILIES TOTAL1®). The submission (K182782) focuses on showing that the modified device remains substantially equivalent to the predicate device. Therefore, the information required for a study proving device meets acceptance criteria, particularly for a new device with specific performance metrics, is not directly applicable or comprehensively provided as it would be for a novel AI/software medical device.

Based on the document, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one would expect for an AI/software device with quantitative metrics like sensitivity, specificity, etc.
Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" is assessed by showing that the modified device's characteristics are the "same as" the predicate device in key areas, and that non-clinical testing confirms its safety and effectiveness.

Here's a table derived from the "Comparison to Technological Characteristics with the Predicate Device" and "Performance Data" sections:

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