Search Results

The ADORE (polymacon) Spherical Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. 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. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:
Eyecare 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.

Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

The ADORE soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The ADORE soft contact lenses are fabricated from polymacon, which has been adopted by the United States Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution.

ADORE lenses are available clear, tinted for visibility/handling, and tinted to enhance or alter the apparent color of the eye. Tinted or color lens designs may be distributed under unique or "private label" trade names. ADORE lenses are available in gray, green, yellow, hazel, blue, white or black which are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), D&C Green No. 6, 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 or color lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by entrapment of the listed color additives in the center of the contact lens (surrounded by 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 color lens tinting pattern has a minimum Clear Pupil diameter of 6.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are: Refractive Index 1.435, Light Transmission (clear) greater than 98%, Light Transmission (tinted/color) greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter); Opaque or 0-10% (at tinted region corresponding to iris), Surface Character hydrophilic, Water Content 38±2%, Specific Gravity 1.17 (hydrated), Oxygen Permeability 11.15x10-11 (cm²/sec)(ml O₂)(ml x mm Hg @ 35°C) (revised Fatt method).

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. ADORE (polymacon) Spherical Soft Contact lenses are available in the spherical configuration with the following features and properties: Chord Diameter 14.00 mm, Center Thickness 0.08 mm (to – 3.00D), Base Curve 8.6 mm, Power Range From D. 0.00 to D. -16.00 (from D. -5.00 a D. -16.00 with 0.50 steps) From D. +0.25 to D. +10.00 (from D. +5.00 to D. +10.00 with 0.50 steps), Colors available Grey, Hazel, Yellow, Blue, White, Green.

ADORE lenses are supplied sterile in saline solution containing blister packages with a base made from polypropylene and a laminated foil seal on top. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

The provided text describes the ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses and its substantial equivalence to a predicate device, ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses. The submission focuses on non-clinical testing and refers to the previously established clinical performance of the lens material.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the device performance. Instead, it compares the physical and material properties of the new device (ADORE) to its predicate device (ChicView) to demonstrate substantial equivalence. The "reported device performance" refers to the measured properties of the ADORE lenses.

The acceptance rationale for these properties appears to be that the ADORE device properties are identical to those of the legally marketed predicate device, ChicView, thus demonstrating substantial equivalence. The document states, "The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the ADORE contact lens material is equivalent to the predicate devices identified previously."

2. Sample size used for the test set and the data provenance

The document states: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses." However, it does not specify the sample size for these tests.

Regarding data provenance: "All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols." The document does not explicitly state the country of origin of the data, nor does it specify if the non-clinical tests were retrospective or prospective. Given the nature of pre-clinical in vitro and in vivo tests for a new device, they are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes non-clinical testing (toxicology, biocompatibility, physical properties) which usually involves laboratory measurements and standardized protocols rather than expert ground truth establishment in the same way clinical studies would. For the comparison to the predicate device, it is based on documented properties of the predicate device rather than expert review of the new device against a ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where subjective assessments might be involved, or for establishing ground truth in diagnostic studies. The testing performed for this device appears to be primarily objective non-clinical measurements.

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, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an AI-assisted diagnostic 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, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" would be established by the results of standardized laboratory tests and measurements, following valid scientific protocols and GLP regulations. For example, sterility tests, material property measurements (water content, oxygen permeability), and toxicology assays provide objective data.

For the clinical aspect, the document states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." This implies that the clinical "ground truth" for the material's safety and effectiveness was based on prior clinical studies and outcomes data for the polymacon material, likely involving patient wear experience and clinical evaluations.

8. The sample size for the training set

Not applicable. This device is a contact lens; it does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. As stated above, there is no training set for this type of device.

Ask a specific question about this device