(79 days)
The VISTAKON® (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (galyfilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON® (galyfilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON® (galyfilcon A) Toric-Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON® (galyfilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
• The VISTAKON® (galyfilcon A) Contact Lens Clear and Visibility Tint with UV blocker is available as a spherical lens, a multifocal lens, a toric lens and a toric-multifocal lens.
- The lens material, galyfilcon A, is a copolymer of 2-hydroxyethyl . methacrylate and (3-methacryloxy-2-hydroxypropyloxy) propylbis(trimethylsiloxy)methylsilane and N.Ndimethylacrylamide, and polyvinylpyrrolidone and mPDMSmonomethacrylate (n=11), and 2-propenoic acid, 2-methyl-, 1,2ethandiyl ester.
- The VISTAKON® (galyfilcon A) Contact Lens may be tinted blue . using Reactive Blue Dye #4 to make the lens more visible for handling.
- · A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 1% in the UVB range of 280 – 315nm and less than 10% in the UVA range of 316 - 380nm.
- · The VISTAKON® (galyfilcon A) Contact Lens is a hemispherical or hemitoric shell.
- . The lens is supplied in a sterile state, packaged in a buffered saline solution with up to 0.01% methyl ether cellulose.
- . The composition of the lens is 53% galyfilcon A and 47% water by weight when hydrated and stored in the buffered saline solution.
The provided document is a 510(k) Premarket Notification for a contact lens, specifically the VISTAKON® (galyfilcon A) Contact Lens. It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical and clinical studies conducted. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness from scratch through detailed performance criteria against absolute benchmarks. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document relate to its comparison to the predicate device and adherence to established clinical guidelines for contact lens studies.
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance
For a 510(k) application for a contact lens, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to a predicate device. This is achieved by showing comparable safety and effectiveness, which includes similar material properties, chemical and physical characteristics, and clinical performance (e.g., adverse reaction rates, visual acuity, comfort, fit).
| Acceptance Criteria Category (Implied for 510(k)) | Reported Device Performance (VISTAKON® (galyfilcon A) Contact Lens) |
|---|---|
| Material Composition | Galyfilcon A copolymer (similar to predicate's lotrafilcon A, both FDA Group I) |
| Physical/Chemical Properties | Water Content: 48% (Labeled 47%) - Predicate: 23% (Labeled 24%) |
| Refractive Index @ 20°C: 1.4055 (Labeled 1.41) - Predicate: 1.4263 (Labeled 1.43) | |
| Dk (edge corrected): 55.4 (Labeled 60) - Predicate: 141.3 (Labeled 140) | |
| Dk (non-edge corrected): 68.3 (Labeled 70) - Predicate: 167.6 (NA) | |
| Base Curve, mm: 8.35 (Labeled 8.3) - Predicate: 8.47 (Labeled 8.4) | |
| Diameter, mm: 14.11 (Labeled 14.0) - Predicate: 13.8 (Labeled 13.8) | |
| Power, D: -1.03 (Labeled -1.00) - Predicate: -1.11 (Labeled -1.00) | |
| Note: While some values differ, the intent is to show the device functions as expected within its classification and intended use. | |
| Biocompatibility/Toxicity | Not toxic and not irritating (based on in vitro and in vivo preclinical toxicology and biocompatibility tests). |
| Clinical Safety & Efficacy | "Similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to concurrent controls when used under daily wear conditions." (Implies comparable adverse event rates and acceptable clinical outcomes to the predicate). |
| Indications for Use | Spherical, Multifocal, Toric, Toric-Multifocal for daily wear, correction of refractive ametropia, presbyopia, astigmatism, with UV blocking. (Comparable to predicate and within general soft contact lens indications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Clinical Study): At least 50 patients (with a 2:1 ratio of subject device to predicate device).
- Data Provenance: The document does not explicitly state the country of origin.
- Study Design: Prospective ("A three-month clinical study was completed to evaluate the safety and efficacy...").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For contact lens studies, "ground truth" typically refers to objective clinical measurements and expert clinical evaluations by ophthalmologists or optometrists, but the number and qualifications of such experts are not specified in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not explicitly provided in the document. Clinical studies typically involve expert evaluations, but the specific adjudication method for discrepancies (if any) is not detailed.
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 is not applicable here as this is a contact lens, not an AI-powered diagnostic device that would involve human "readers" interpreting cases with or without AI assistance. The study compares two contact lenses.
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 contact lens, not an algorithm. Its performance is evaluated through clinical use by human wearers. Non-clinical (in vitro) tests were performed on the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" and evaluation metrics included:
- Clinical Outcomes Data: Adverse reactions, keratometry changes, reasons for discontinuations, number of reasons for unscheduled lens replacements, and overall clinical performance in terms of vision, health, comfort, and fit.
- Expert Clinical Evaluation: Implicitly, the "clinically relevant areas of vision, health, comfort and fit" would have been assessed by eye care professionals.
For non-clinical testing:
- Laboratory-measured properties: Material composition, water content, refractive index, Dk values, base curve, diameter, power.
- Toxicology and Biocompatibility Tests: These would involve standardized assays and observations to determine toxicity and irritation, which serve as "ground truth" for these specific aspects.
8. The sample size for the training set
This contact lens is not an AI algorithm, so there is no "training set" in the machine learning sense. The manufacturing process and formulation were developed through traditional R&D, not algorithmic training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI algorithm. The performance of the contact lens product is evaluated against its intended use and comparison to a predicate device.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.