(78 days)
Device Name: Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear(clear and tinted)
The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfaction systems.
Device Name: Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted)
The Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems,
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eve including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of alding in lens centration and comfort.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document describes a 510(k) premarket notification for contact lenses, which primarily relies on substantial equivalence to predicate devices rather than independent clinical performance studies with specific acceptance criteria that would typically be seen for AI/ML devices or novel therapies. Therefore, much of the requested information regarding detailed performance metrics, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance is not applicable or present in this type of submission.
The "acceptance criteria" here relate more to the equivalence of the physical, chemical, and optical properties of the new device to the predicate device, as well as meeting regulatory classifications for materials. The "study" mentioned isn't a performance study in the AI/ML sense but rather the validation that the new device's manufacturing and properties match those of the predicate.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for contact lenses based on substantial equivalence, the "acceptance criteria" are implied by the comparison to the predicate device. The performance is not reported as quantitative metrics but as equivalence.
| Criterion Type | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Material Equivalence | The new device's formulation and material (methafilcon A) must be identical to the predicate device, classified as a Group 4 ionic, high water content polymer. | "The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Wear (clear and tinted) and Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted) are substantially equivalent to... The LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted) and the LifeStyle 55 (methafilcon A) Single Vision Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted)... This lens is in Group 4 ionic, high water content polymers as established by the FDA..." The submitter received all manufacturing information, including formulation, from the predicate device manufacturer. |
| Manufacturing Process Equivalence | Manufacturing processes (polymerization, tinting, sterilization, packaging) must be identical or substantially similar to the predicate device. | "Specialty UltraVision, Inc. has received from the manufacturer of the predicate device all manufacturing information including; but not limited to, formulation, manufacturing processes (including polymerization conditions, tinting process, lens parameter tolerances, sterilization and packaging, quality control/quality assurance, established shelf life data, shelf life protocol), and labeling; necessary to manufacture the devices... In addition, Specialty UltraVision, Inc. will manufacture these devices at the same manufacturing location as the predicate devices." |
| Physical/Optical/Chemical Properties Equivalence | The physical, optical, and chemical properties (e.g., center thickness, diameter, base curve, corrective power range) must match those of the predicate device. | "The physical, optical, and chemical properties of the Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Wear (clear and tinted) and the Specialty Choice (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear(clear and tinted) are equivalent to those of the LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft Contact Lens for Daily Wear(clear and tinted) and the Lifestyle 55 (methafilcon a) Single Vision Soft Contact Lens for Daily Wear(clear and tinted)." |
Specific parameter ranges are listed for each product, indicating they align with the predicate's offerings. |
| Intended Use Equivalence | Indications for use (e.g., daily wear, correction of refractive ametropia, presbyopia, astigmatism limits, disinfection systems) must be identical to the predicate device. | "The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses... are substantially equivalent to the indication for use of the LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft Contact Lens... and the LifeStyle 55 (methafilcon A) Single Vision Soft Contact Lens." The indications for use described for both Specialty Progressive and Specialty Choice explicitly mirror the common indications for such contact lenses, consistent with predicate devices. |
Specific Study Information (Not Applicable for this Submission Type)
The provided text describes a 510(k) submission based on substantial equivalence, not a clinical performance study with defined performance endpoints, ground truth, or expert review for a diagnostic or AI/ML device. Therefore, the following points are not directly addressed or applicable in this document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the sense of a clinical performance dataset, as performance is established by equivalence of manufacturing, materials, and established parameters.
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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): Not applicable. "Ground truth" in this context would implicitly refer to the established and accepted safe and effective parameters and performance of the predicate device, which have already undergone regulatory scrutiny.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for demonstrating substantial equivalence lies in the established regulatory acceptance of the predicate device's materials, manufacturing, and performance.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, this 510(k) submission establishes the safety and effectiveness of the new contact lenses by demonstrating their substantial equivalence to legally marketed predicate devices. The "study" here is the comparison and documentation of identical materials, manufacturing processes, physical/optical/chemical properties, and indications for use, rather than a de novo clinical performance trial.
§ 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.