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510(k) Data Aggregation
(125 days)
Sphere/Asphere:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) 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 VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye.
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from mififilcon A. which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lenses consist of 40.0% mififilcon A and 60.0% water by weight when immersed in saline solution. The mififilcon A name has been adopted by the United States Adopted Names Council (USAN).
The VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus Color (miffilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green, Mica.
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >80% in the UVA range (316mm - 380mm). The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are manufactured in spherical/aspheric, toric, and multifocal design configurations.
The provided text describes the 510(k) submission for VizionFocus contact lenses, demonstrating their substantial equivalence to predicate devices. However, this submission does not contain acceptance criteria or study details for an AI/ML powered medical device. The document pertains to contact lenses, which are physical medical devices, not software-based AI/ML devices. Therefore, a table of acceptance criteria and study proving an AI device meets acceptance criteria cannot be extracted from this text.
The information provided describes:
- Device Type: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens. These are physical contact lenses, not an AI/ML powered device.
- Study Purpose: To demonstrate the safety and effectiveness of the contact lenses by comparing them to legally marketed predicate devices, establishing substantial equivalence. This is a typical regulatory pathway for physical medical devices.
- Studies Conducted: Non-clinical performance testing (biocompatibility/toxicology, shelf life, bench tests like refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals) and a clinical study.
- Clinical Study Design: Multi-center, single-masked (examiner), bilateral, randomized concurrent-control study with 91-day treatment follow-up.
- Clinical Study Sample Size: 120 subjects enrolled (60 test, 60 control), 117 completed.
- Clinical Study Data Provenance: Not explicitly stated, but typically clinical trials for FDA submissions are conducted in the US or in compliance with international standards that are accepted by the FDA. The indication of a multi-center study implies diverse geographic recruitment within the study's operational regions.
- Ground Truth: For the clinical study, the ground truth was established through biomicroscopy findings, symptoms, adverse reactions, and vision safety measures (keratometry changes, refractive changes, best corrected visual acuity) observed and recorded by examiners. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for an AI model.
The prompt specifically asks for details around an AI/ML powered medical device's acceptance criteria and study, which are not present in the provided text.
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(56 days)
FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are indication 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 and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
FreshLook® Progressives (nelfilcon A) One Day Color 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 FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.
The FreshLook® (nelfilcon A) One Day Color 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® (nelfilcon A) Soft (hydrophilic) One Day Color Contact Lenses are available in a spherical lens design, FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are available in a multifocal lens design and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are available in a toric design. The lenses are to be prescribed for single use daily disposable wear.
The FreshLook®, FreshLook® Toric and FreshLook® Progressives (nelfilcon A) One-Day Colors Contact Lens are daily wear soft contact lenses intended for single use daily disposable wear. The FreshLook One-Day Colors contact lens is a spherical soft contact, FreshLook One-Day Colors Toric lenses have a double thin zone design, and the FreshLook One-Day Colors 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 (polyvinyl 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). FreshLook® (nelfilcon A) One Day Color Contact Lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, [phthalocyaninato (2-)] copper, chromium oxide and carbazole violet.
Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.
The physical properties of the lenses are:
Refractive Index: 1.38 (hydrated)
Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00D; 0.15 at +3.00D) (varies with power)
Light Transmittance: Clear ≥ 97%, Visitint 96% (approx)
Oxygen Permeability (Dk): 26 x 10-11 (cm2/sec) (ml O2/ml x mm Hg) at 35° C (Fatt corrected)
Water Content: 69% by weight in normal saline
The provided text describes specific details about FreshLook® contact lenses and compares them to predicate devices. It does not contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets such criteria.
Instead, the document is a 510(k) Summary of Safety and Effectiveness, which compares FreshLook® (nelfilcon A) One Day Color Soft Contact Lenses to previously cleared predicate devices to establish substantial equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment. The document explicitly states:
- "It was determined that Clinical Studies were not necessary to establish the safety it was dotemined the FreshLook® One Day Color (nelfilcon A) Soft Contact Lenses." (Page 4)
This indicates that a clinical study with specific performance metrics and acceptance criteria was not conducted or deemed necessary for this 510(k) submission. The equivalence was based on physical/chemical properties and manufacturing processes compared to predicate devices.
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(27 days)
DAILIES® (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 eyes.
DAILIES® (nelfilcon A) ONE-DAY CONTACT 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 DAILIES® (nelfilcon A) ONE-DAY CONTACT LENS is a daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution.
Here's a breakdown of the acceptance criteria and study information for the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens, based on the provided document:
This document is a 510(k) Summary of Safety and Effectiveness for a "parametric release" of the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens. It's crucial to understand that a parametric release means the device itself is not new, but rather a change in the sterilization release criteria is being submitted. Therefore, the "study" described focuses on validating the sterilization process, not the clinical performance of the contact lens.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Sterilization) | Reported Device Performance (Sterilization) |
|---|---|
| Sterilization cycle: chamber temperature of 121 to 124°C for 45 consecutive minutes, with chamber pressure of 2.6 ± 0.2 bar. | A successful sterilization cycle includes these parameters. (Note: This is the description of the validated process, which by definition "meets" the criteria if the process is followed). |
| Deliver sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 10⁻⁶ probability of microbial survival. | The sterilization cycle is "based on an overkill approach, delivering sufficient lethality to provide a minimum 12-log reduction of microorganisms and at least a 10⁻⁶ probability of microbial survival regardless of the number and heat resistance of the naturally occurring microorganisms." |
| Typical Sterility Assurance Level (SAL) obtained during validation study. | Consistently greater than 10⁻³². |
| Production bioburden levels (pre-sterilization). | Consistently below both 1000 vegetative CFU and 20 spore forming CFU over a 4-month period. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set for device performance. Instead, it focuses on the sterilization process.
- Test Set Description: The "test set" in this context refers to the samples used to validate the sterilization process and monitor bioburden.
- Sample Size (Sterilization Validation): Not explicitly stated in terms of a number of devices. The validation is described as an "overkill approach" implying robust testing. The SAL of 10⁻³² is a result of extensive validation.
- Sample Size (Bioburden Monitoring): "Results obtained from measurement of product bioburden over a 4-month period" suggests continuous monitoring, but a specific number of samples taken during this period is not provided.
- Data Provenance: The document is from CIBA Vision Corporation, located in Duluth, GA, USA. The data would therefore be assumed to be from their manufacturing facilities. The nature of the data is prospective for both initial sterilization validation and ongoing bioburden monitoring.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. There is no human expert "ground truth" involved in evaluating the performance of the sterilization process; it's based on objective physical measurements and microbiological assays. The "ground truth" is established by adherence to microbiological sterility standards.
4. Adjudication Method for the Test Set
Not applicable. There's no subjective assessment requiring adjudication in the context of sterilization validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a material/process change related to sterilization, not an assessment of the clinical effectiveness or diagnostic performance of the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (contact lens) and a manufacturing process (sterilization), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is:
- Sterilization Validation: Microbiological testing (e.g., spore strips, lethality calculations) demonstrating the destruction of a specified number of microorganisms, and physical monitoring of autoclave parameters (temperature, pressure, time). The target microbial reduction (12-log) and probability of survival (10⁻⁶) are established industry standards for sterility.
- Bioburden Monitoring: Direct measurement of CFU (colony-forming units) of vegetative and spore-forming bacteria from product samples. This is a direct, objective microbiological measurement.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the validation of a manufacturing process against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML device. For the sterilization validation, the ground truth is established by:
- Engineering principles and scientific validation protocols for steam sterilization processes.
- Microbiological testing, often involving inoculation of representative product with a known challenge organism and subsequent culturing to demonstrate inactivation.
- Adherence to regulatory standards and guidance (e.g., from FDA, ISO) for sterile medical devices.
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