(98 days)
The VISTAKON® (narafilcon B) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (narafilcon B) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 4.00D of ADD power or less and 0.75D of astigmatism or less.
The VISTAKON® (narafilcon B) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon B) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eves who may have 4.00D of ADD power or less and 10.00D of astigmatism or less.
VISTAKON® (narafilcon B) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfection is required.
The VISTAKON® (narafilcon B) Contact Lens Visibility Tinted with UV Blocker is available as a spherical lens, multifocal lens, toric lens, and toric-multifocal lens. The lenses are made of a silicone hydrogel material containing an internal wetting agent. The VISTAKON® (narafilcon B) Contact Lens 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 280-315nm and less than 10% in the UVA range of 316-380nm. The VISTAKON® (narafilcon B) Contact Lens is a hemispherical or hemitoric shell. The lens is supplied in a sterile state, packaged in a buffered saline solution with methyl ether cellulose. The composition of the lens is 52% narafilcon B and 48% water by weight when hydrated and stored in the buffered saline solution.
Here's a summary of the acceptance criteria and study details for the VISTAKON® (narafilcon B) Contact Lens, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly list distinct "acceptance criteria" with specific thresholds for the clinical study. Instead, it describes "primary endpoints" and indicates that the device demonstrated "similar overall performance" to the control lens. The comparison focuses on non-inferiority to a predicate device, rather than meeting predefined numerical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy comparable to predicate device | Non-clinical testing (in-vitro and in-vivo toxicology, biocompatibility) demonstrated: |
- Lens material and/or extracts are non-toxic, non-irritating, and non-sensitizing.
- Lens physical and material properties are consistent with currently marketed lenses. |
|
Clinical evaluation demonstrated similar overall performance in clinically relevant areas of vision and health compared to concurrent controls (1∙DAY ACUVUE® Brand Contact Lenses) under daily wear single-use conditions. |
| Primary Endpoints for Clinical Study: | |
| Slit lamp findings | Demonstrated similar performance to control lens. |
| Symptoms Problems and complaints | Demonstrated similar performance to control lens. |
| Visual acuity | Demonstrated similar performance to control lens. |
| Average wear time | Demonstrated similar performance to control lens. |
| Additional Parameters Measured: | |
| Adverse reactions | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Keratometry changes | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Reasons for discontinuation | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Number and reasons for unscheduled lens replacements | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Biocompatibility/Toxicology | The lens material and/or extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions. |
| Physical and Material Properties | The lens physical and material properties are consistent with currently marketed lenses. (Specifically compared to VISTAKON® (narafilcon A) Contact Lens for water content, refractive index, Dk, base curve, diameter, and power – see Technological Characteristics table for values, though no acceptance criteria are given for these, only comparative values). |
Study Details
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Sample size used for the test set and the data provenance:
- Clinical Study (Test Set): 48 subjects, with a 1:1 ratio between the test lens (VISTAKON® (narafilcon B) Contact Lens) and the control lens (1∙DAY ACUVUE® Brand Contact Lenses).
- Data Provenance: The document does not specify the country of origin. The study was a "one-month clinical study" performed to evaluate safety and efficacy, implying it was prospective. Non-clinical studies were "in-vitro and in-vivo preclinical toxicology and biocompatibility tests."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study's endpoints (e.g., slit lamp findings, visual acuity). These are typically assessed by trained clinical investigators (e.g., optometrists, ophthalmologists) following standard clinical protocols.
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Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study. Clinical studies typically rely on predefined assessments by trained personnel.
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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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a contact lens, not an AI-based diagnostic tool. The clinical study directly compared the performance of the new contact lens to an existing control lens in human subjects.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a contact lens, not an algorithm. The non-clinical testing included standalone in-vitro tests of the lens material and in-vivo preclinical toxicology/biocompatibility, but not algorithm-only performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study: The "ground truth" for the clinical study outcomes was based on direct clinical observation and measurement of various physiological parameters and patient-reported outcomes (e.g., slit lamp findings, visual acuity, symptoms, wear time). This falls under a combination of "expert assessment" and "outcomes data" as measured in a controlled clinical environment.
- Non-clinical Testing: Ground truth for these tests would be established by standard analytical and experimental methodologies for toxicology, biocompatibility, and material properties, against predefined benchmarks or comparisons (e.g., ISO standards, predicate device characteristics).
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The sample size for the training set:
- Not applicable as this is a physical medical device (contact lens), not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.