(84 days)
The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
The VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a multifocal lens, a toric lens and a toric multifocal lens.
The lens material (lenefilcon A) is a copolymer of 2-hydroxyethyl 2-methyl-2 propenoate and 2-propenic acid, 2-methyl-2,3-dihydroxypropyl ester cross-linked with poly (oxy-1,2-ethanediyl) (4) bis (2-methyl-2-propenoate). The VISTAKON Contact Lens Visibility Tint with UV Blocker is 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 280nm to 315nm and less than 10% in the UVA range of 316nm to 380nm. The VISTAKON Contact Lens is a hemispherical or hemitoric shell.
The VISTAKON (lenefilcon A) Soft Contact Lens is a contact lens with various designs (spherical, multifocal, toric, and toric multifocal) intended for daily wear to correct refractive ametropia. The study for this device did not involve an AI component, nor did it involve the evaluation of expert performance with or without AI assistance. Instead, it was a clinical and non-clinical study to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria / Predicate Device Performance (NewVues® (vifilcon A)) | Reported Device Performance (VISTAKON (lenefilcon A)) |
|---|---|---|
| Material Properties: | ||
| Water Content, % | 55 (labeled) / 56 (measured) | 55 (labeled) / 55 (measured) |
| Refractive Index @ 20°C | 1.415 (labeled) / #1.41 (calculated) | 1.41 (labeled) / 1.41 (measured) |
| Dk, edge corrected | 16 (labeled) / 18 (measured) | 16 (labeled) / 17 (measured) |
| Dk, non-edge corrected | 16 (labeled) / 22 (measured) | 21 (labeled) / 22 (measured) |
| Color (if tinted) | Blue | Blue |
| Physical Dimensions: | ||
| Base Curve, mm | 8.5 (labeled) / 8.5 (measured) | 8.84 (labeled) / 8.86 (measured) |
| Diameter, mm | 14.0 (labeled) / 14.3 (measured) | 14.05 (labeled) / 14.10 (measured) |
| Power, D | -1.00 (labeled) / -1.02 (measured) | -0.74 (labeled) / -0.79 (measured) |
| Toxicology: | No evidence of toxicity/irritation and meeting ISO requirements | Passed Cytotoxicity, Ocular Irritation (Rabbit), Acute Systemic Toxicity (Mouse) |
| Microbiology: | Minimum SAL of 10-6 for sterilization; demonstrated disinfection efficacy with care products | Sterilization process validated to minimum SAL of 10-6; shelf-life stability data support sterility |
| Clinical Equivalence: | Substantial clinical equivalence to predicate device | Found to be at least substantially clinically equivalent to the predicate device |
| UV Blocker Transmittance: | N/A (implicit that it blocks UV) | Less than 1% in UVB (280-315nm), less than 10% in UVA (316-380nm) |
Notes on Acceptance Criteria:
- The acceptance criteria for the material properties and physical dimensions are implied by demonstrating substantial equivalence to the predicate device. The performance data for the VISTAKON lens is compared directly to the predicate device's data.
- For non-clinical studies (toxicology, chemistry, microbiology), the acceptance criteria are based on established standards and previous demonstrations of compatibility (e.g., ISO studies, validated sterilization processes).
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: At least 50 patients participated in the clinical trial. The ratio of subject device to predicate device was 2:1.
- Data Provenance: Not explicitly stated, but clinical trials for US FDA submissions are typically conducted in the US. The study evaluated "Daily Wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994)," which implies US-centric regulatory guidelines. The study was prospective as it involved a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The submission does not specify the number or qualifications of experts (e.g., ophthalmologists, optometrists) involved in establishing the ground truth or evaluating patient outcomes in the clinical trial. However, clinical trials for contact lenses typically involve qualified eye care professionals for examinations and assessments.
4. Adjudication Method for the Test Set
The submission does not explicitly describe an adjudication method for the clinical study's evaluations (e.g., 2+1, 3+1). Clinical trials generally involve standardized protocols for examinations and reporting adverse events, which implicitly serve as a form of "ground truth" establishment by the clinical investigators.
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 such study was performed or is applicable to this device. This submission is for a medical device (contact lens), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
For the clinical study:
- The "ground truth" was established through direct clinical observation and measurement of various parameters in patients wearing the contact lenses. These parameters included:
- Adverse reactions
- Symptoms
- Problems and complaints reported by patients
- Slit lamp evaluations (objective assessment of ocular health)
- Visual acuity (objective measurement of vision correction)
- Lens wear time
- Fit assessment
- Discontinuations from the study
- For non-clinical studies (chemistry, toxicology, microbiology), the ground truth was based on established scientific protocols, validated methods, and regulatory standards (e.g., ISO studies, validated sterilization processes).
8. The Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI model requiring a training set. The "training" for the device would be its manufacturing process and design, refined through R&D.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. The development of the VISTAKON contact lens material and design would have involved extensive R&D, material characterization, and design optimization based on scientific principles and previous knowledge of contact lens technology.
§ 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.