(54 days)
The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The Desio (hioxifileon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for 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 disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from hioxifilcon D, which is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA), and cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, C.I. Reactive black 5.
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the pad-printing manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >67% in the UVA range (316nm - 380nm).
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses will be manufactured in the sphere and toric design configurations.
Here's a breakdown of the acceptance criteria and the study information for the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Tolerance*) | Reported Device Performance |
|---|---|---|
| Chord Diameter | ±0.20 mm | Not explicitly reported as a single value, but range 12.80 mm to 15.00 mm |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10% | |
| When > 0.10 mm → ±0.015 mm + 5% | Not explicitly reported as a single value, but range 0.05 mm to 0.210 mm | |
| Base Curve | ±0.20 mm | Not explicitly reported as a single value, but range 7.85 mm to 10.0 mm |
| Back Vertex Power (F'v) | When 0.00 1.50 D → ±5° | Not explicitly reported as a single value, but range 10° to 180° |
| Surface Appearance | Lenses should be clear with no surface defect | Not explicitly reported, but implied by compliance with acceptance criteria. |
| Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | ±20% (relative to a specific value) | 21.50 |
| Light Transmission - Clear (@ 380-780nm) | ±5% (relative to a specific value) | >98% |
| Light Transmission - Tinted (@ 380-780nm) | ±5% (relative to a specific value) | >96% (at pupil); Opaque or 0-10% (at iris) |
| Ultraviolet Radiation Transmittance | TUVB (280 to 315 nm) 95% UVB and >67% UVA) | |
| Water Content | ±2% | 54% |
| Refractive Index (hydrated) | ±0.005 | 1.400 |
*Note: The "Tolerance" column is directly from the provided text and represents the acceptance criteria for each parameter. The "Reported Device Performance" column directly states the device's measured or designed values for these parameters. The document implies that the device performance meets these tolerances without explicitly stating "passed" for each one.
Study Details
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Sample size used for the test set and the data provenance:
- The document describes non-clinical testing including toxicology, shelf-life, and physicochemical & mechanical properties. However, it does not specify explicit sample sizes for these tests beyond general statements like "A series of preclinical testing was performed."
- Data Provenance: The toxicology tests were conducted "in accordance with the GLP regulation." The overall testing was conducted in laboratories, with the data determined to be scientifically valid under 21 CFR 860.7. No specific country of origin for the test data is mentioned, but the submitter is Qualimed SRL in Italy. The tests are considered retrospective as they are performed on the manufactured product to demonstrate its properties.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided regarding experts establishing ground truth for the non-clinical tests. These tests typically rely on standardized laboratory procedures and measurements rather than expert human interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as the reported tests are objective measurements for physical and chemical properties and toxicology, not requiring adjudication of human interpretations.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This device is a contact lens.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a contact lens, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is based on objective measurements and standardized test protocols. For example:
- Cytotoxicity: Measured by ISO 10993-5.
- Systemic Toxicity: Measured by ISO 10993-11.
- Acute Ocular Irritation: Measured by ISO 10993-10.
- Physicochemical & Mechanical Properties: Measured to assess refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals against established material standards (implied, as they support substantial equivalence).
- For the non-clinical tests, the "ground truth" is based on objective measurements and standardized test protocols. For example:
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The sample size for the training set:
- Not applicable. This document describes the testing for a physical medical device (contact lenses) and does not involve AI or machine learning algorithms that require training sets.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used.
§ 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.