(73 days)
The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) 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.
Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.
The VISTAKON (genfilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a spherical multifocal lens and an astigmatic (toric) lens. The lens material (genfilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and ethylene glycol dimethacrylate. The VISTAKON Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. The VISTAKON Contact Lens is a hemispherical shell.
This document describes the Vistakon (genfilcon A) Contact Lens. The provided text, however, focuses on showing substantial equivalence to a predicate device and does not define explicit acceptance criteria or provide a detailed study report with performance metrics against those criteria. Instead, it outlines the non-clinical and clinical studies conducted to demonstrate safety and effectiveness.
Here's an analysis of the provided information based on the request, with the understanding that specific numerical "acceptance criteria" against which a device's performance is measured are not explicitly stated in this 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative "acceptance criteria" are not provided in the typical sense (e.g., "sensitivity must be >X%"). Instead, the studies aim to demonstrate that the device is safe and effective for its intended use and substantially clinically equivalent to the predicate device. The performance is implicitly assessed by showing that it does not pose new or greater risks, and offers comparable benefits to the predicate.
| Criteria/Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material Properties (Chemistry) | Properties consistent with FDA Group I lenses; compatible with approved lens care products; acceptable shelf-life stability; no significant difference in leachable materials compared to predicate. | Material property data reflected properties of Group I lenses. Lens care product manufacturers previously showed compatibility with Group I lenses. Shelf-life stability based on approved protocols (initial claim after 6 months real-time data). No significant differences in leachable materials found between subject and predicate device. |
| Toxicology | Extracts not considered ocular irritants; extracts not considered systemically toxic; lens not cytotoxic. | Ocular Irritation study indicated extracts would not be considered ocular irritants. USP Systemic Toxicity study indicated extracts would not be considered systemically toxic. Cytotoxicity study indicated the lens is not cytotoxic. |
| Microbiology/Sterilization | Sterilization process validated to deliver a minimum SAL of 10^-6; compatible with approved disinfection efficacy of lens care products; sterility maintained throughout shelf-life. | Moist heat sterilization validated to deliver a minimum SAL of 10^-6. Lens care product manufacturers established disinfection efficacy in lens groups. Shelf-life stability data supports lens sterility. |
| Clinical Safety & Effectiveness (Daily Wear) | Safe and effective for intended use; substantially clinically equivalent to the predicate device (Optima FW). No new or increased adverse reactions, symptoms, problems, or complaints; comparable slit lamp evaluations, visual acuity, lens wear time, and fit assessment; comparable discontinuation rates. | The VISTAKON (genfilcon A) trial contact lens was found to be safe and effective for its intended use and at least substantially clinically equivalent to the predicate device. Parameters measured included adverse reactions, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time, fit assessment, and discontinuations. (Specific comparative metrics not provided in this summary, but the conclusion states equivalence). |
| Overall Legal Standing (510(k) Purpose) | Safety and effectiveness supported; substantially equivalent to the predicate device. | "The data presented in this Premarket Notification support the safety and effectiveness of the subject device... The subject device has been shown to be substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "at least 50 patients with a 2:1 ratio of subject device to predicate device".
- This means
33patients for the subject device (VISTAKON) and17patients for the predicate device (Optima FW), totaling 50 patients.
- This means
- Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical trial for 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 it was conducted to meet US regulatory requirements. It was a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not describe the establishment of a "ground truth" in the way it would for an AI-powered diagnostic device (e.g., expert consensus on image labels). Instead, patient outcomes and clinical assessments were the primary endpoints.
- The clinical trial involved "eye care practitioners" who evaluated parameters such as slit lamp evaluations, visual acuity, and fit assessment. Their specific qualifications (e.g., "ophthalmologist with X years of experience") are not detailed in this summary.
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method (such as 2+1 or 3+1 consensus) for the clinical trial data. Clinical trials typically rely on standardized protocols and trained clinical investigators to collect and assess data, not necessarily an "adjudication" panel for ground truth in the AI sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study, as typically described for AI systems, was not performed. This product is a contact lens, not an AI diagnostic system. The clinical study compares the subject device directly to a predicate device in human patients, assessing endpoints related to safety and performance. There is no concept of "human readers improving with AI vs without AI assistance" in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable as the submission is for a physical medical device (contact lens), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth"
- For non-clinical studies: Laboratory measurements, chemical analyses, toxicology tests, and microbiological validation following established scientific protocols and GLP regulations.
- For clinical studies: Patient-reported outcomes (symptoms, complaints), objective clinical measurements (slit lamp evaluations, visual acuity), and assessments by qualified eye care practitioners (fit assessment, adverse reactions). The overall "ground truth" for the clinical trial was the observed safety and effectiveness in patients compared to the predicate device.
8. The Sample Size for the Training Set
- This is not applicable, as this is a contact lens submission and does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This is not applicable, as there is no training set for an AI model.
§ 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.