Search Results

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and 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.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated 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 (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Iron oxides, Solvent Yellow 18, Titanium dioxide, Carbazole violet, Pigment Blue 36, Phthalocyanine green.

The proposed lenses contain only the amount of color additives to accomplish the intended coloring effect. The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon). As part of the manufacturing process, the color lenses are thoroughly washed to remove the unbound reactive color additives. Because of the 'sandwich' structure, the color additives will not be removed by lens handling and cleaning/disinfecting procedures. The cosmetic tinting pattern has a minimum clear pupil diameter of 6.0 mm.

In the hydrated state, BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina. 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 compatible with the eye.

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Total diameter: 13.50 mm to 14.50 mm, step:0.10 mm; Base curve: 8.00 mm to 9.00 mm, step: 0.10 mm; Center thickness: 0.050 mm to 0.120 mm; Back vertex power: -10.00D to 0.00D, step: 0.25D.

The physical properties of the proposed lens are: Refractive index: 1.435; Light Transmission: ≥95% (at clear region corresponding to pupil, minimum 6.0 mm diameter); Surface character: Hydrophilic; Water content: 38%; Oxygen permeability: 9.01×10-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C (revised Fatt method).

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing standard saline solution.

The provided text describes the submission of a 510(k) premarket notification for a soft contact lens, implying a comparison to a predicate device rather than a study proving the device meets acceptance criteria in the sense of a diagnostic or AI device study.

Therefore, the requested information elements related to AI/diagnostic device studies (such as sample size for test sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type for training sets, or training set sample size) are not applicable or extractable from this document.

However, I can extract the non-clinical performance tests conducted and state what they aim to show. These could be considered "acceptance criteria" in a broad sense for the physical and chemical properties of the contact lens.

Here's the information based on your request, adapted to the context of a contact lens submission:

Acceptance Criteria and Device Performance for BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

This submission is for a medical device (contact lens), and the described "tests" are performance tests for physical, optical, physicochemical, mechanical, and biocompatibility properties to demonstrate substantial equivalence to a predicate device, rather than a clinical study with diagnostic acceptance criteria as might be seen for an AI/diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with "reported device performance." Instead, it lists the types of performance tests conducted and states that "the test results showed that the proposed device meets the requirements." It also provides some specific physical properties of the proposed device as part of the device description. Below is a compilation of the properties and what the testing aimed to achieve, aligning with what would be required for such a device.

The following questions are not applicable to this document as it pertains to a contact lens 510(k) submission which explicitly states "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." The submission focuses on non-clinical performance and biocompatibility to demonstrate equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance: Not applicable. Non-clinical tests were performed on the device itself or its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device