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510(k) Data Aggregation
(52 days)
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS
The ALDEN CLASSIC (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
The ALDEN CLASSIC (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual aculty in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.
The ALDEN CLASSIC (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent 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 eve. 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight.
The Alden Optical Laboratories ALDEN CLASSIC (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted, Lathe-cut from Lens Blank) is a medical device for correcting visual acuity. This summary outlines its acceptance criteria and the study that demonstrates compliance.
1. Acceptance Criteria and Reported Device Performance:
The device's acceptance criteria are based on its substantial equivalence to predicate devices (Co Soft 38 Toric, Metrolite, and BENZ-38) regarding material properties, production method, and lens function. The table below presents these characteristics:
| Characteristic | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (ALDEN CLASSIC) |
|---|---|---|
| Production Method | Lathe-Cut | Lathe-Cut |
| Lens Function | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including astigmatism. | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including astigmatism. |
| Material | Hydrophilic Polymer | Hydrophilic Polymer |
| Water Content | 38% | 38% |
| Polymer Content | 62% | 62% |
| Polymer | polymacon | polymacon |
| DK Value (Oxygen Permeability) | 9 Fatt Units | 9 x 10^-11 Fatt Units (cm^2/sec)(ml O2/ml x mm Hg @ 35° C) (revised Fatt method) |
| Refractive Index (hydrated) | 1.43 | 1.43 |
| Specific Gravity (hydrated) | 1.180 | 1.18 |
| Light Transmission | Greater than 95% T | Greater than 95% T |
2. Sample Size for Test Set and Data Provenance:
The provided document does not describe a clinical study with a "test set" in the traditional sense of evaluating device performance on a new cohort. Instead, the "study" demonstrating the device meets acceptance criteria is a substantial equivalence comparison to existing, legally marketed predicate devices.
Therefore, there is no explicit sample size for a "test set" or data provenance from a prospective or retrospective study of human subjects with the ALDEN CLASSIC lens itself to be reported in this context. The core of the submission relies on the established safety and effectiveness profile of the predicate devices and the identical material and design specifications.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This 510(k) submission is based on demonstrating substantial equivalence through material and design comparison, not a diagnostic or performance test requiring expert review of specific cases or images to establish ground truth. The "ground truth" here is the established performance and safety of the predicate devices.
4. Adjudication Method for Test Set:
Not applicable, as there was no traditional "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This submission focuses on material and design equivalence, not on comparing human reader performance with or without AI assistance. The device is a contact lens, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study in the context of an algorithm's performance without human intervention was not done. The device is a soft contact lens, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" used for this submission is the established safety and effectiveness profile of predicate devices that have already been legally marketed and deemed safe and effective by the FDA. This is based on pre-clinical toxicology and manufacturing/chemistry data of the predicate devices (specifically BENZ-38) and the demonstration that the ALDEN CLASSIC maintains identical specifications.
8. Sample Size for the Training Set:
Not applicable. There is no training set for an algorithm as this is a contact lens submission based on substantial equivalence to existing lenses.
9. How Ground Truth for the Training Set was Established:
Not applicable, as there was no training set.
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