(53 days)
The ALDEN CLASSIC TINTED (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in 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 TINTED (polymacon) Toric 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 and/or possesses refractive astigmatism not exceeding 10 Diopters.
The ALDEN CLASSIC TINTED (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. A Blue tint (transparent/enhancing), 7,16-Dichloro-6, 15-dihydro-5, and 9,14,18anthrazinetetrone is added to the lens.
In the hydrated state, the lens conforms to the curvature of 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 eye. If the lens dries out, it will become hard 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 provided text is a 510(k) summary for a medical device (soft contact lenses) and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the way envisioned by the prompt.
Therefore, many of the requested elements for describing an acceptance criteria study (like sample size, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document.
Here's an attempt to structure the information based on the prompt's request, noting where information is absent:
Acceptance Criteria and Device Performance Study Summary
This submission for the ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted relies on demonstrating substantial equivalence to predicate devices rather than a de novo performance study against specific acceptance criteria. The "acceptance criteria" in this context are interpreted as the critical physical and material properties that allow the device to be considered substantially equivalent to already approved devices.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" are implied by the characteristics of the predicate device, which the new device must match to demonstrate substantial equivalence.
| Characteristic | Implied Acceptance Criterion (from Predicate Device) | Reported Device Performance (ALDEN CLASSIC TINTED) |
|---|---|---|
| Production Method | Lathe-Cut | Lathe-Cut |
| Lens Function | Refractive medium focusing light rays, compensating for refractive error (including astigmatism) | Refractive medium focusing light rays, 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 x 10⁻¹¹ Fatt Units (at 35°C) | 9 x 10⁻¹¹ Fatt Units (at 35°C) |
| Refractive Index | 1.43 (hydrated) | 1.43 (hydrated) |
| Specific Gravity | 1.180 (hydrated) | 1.180 (hydrated) |
| Light Transmission | Greater than 70% T | Greater than 70% T |
| Dye Color | Blue visibility tint (specifically phthalocyanato (2) (copper) for Benz-38) | Blue (7,16-Dichloro-6,15-dihydro-5,9,14,18anthrazinetetrone / 21CDR 73,3119 / CI # 69825) |
Note on Dye Color: The device differs in the specific dye color used compared to the predicate, but this is acknowledged and presumably deemed non-critical for substantial equivalence in safety and effectiveness regarding the overall functionality of a tinted contact lens.
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. The submission relies on comparing material properties and manufacturing processes, not a clinical test set with patient data for performance evaluation.
- Data Provenance: Not applicable.
3. Number of Experts for Ground Truth and Qualifications
- Not applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established for this type of submission. The 'ground truth' for comparison is the established properties of the predicate devices.
4. Adjudication Method for Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not a diagnostic imaging device involving interpretation by multiple readers.
6. Standalone Performance Study
- Not applicable in the typical sense of algorithm-only performance. The "performance" is demonstrated through the equivalence of physical and chemical properties to already approved devices.
7. Type of Ground Truth Used
- The "ground truth" for this substantial equivalence argument is derived from the known and approved specifications and performance characteristics of the predicate devices (Metro Tint and BENZ-38) and established scientific measurements of material properties.
8. Sample Size for Training Set
- Not applicable. There is no AI/machine learning component requiring a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable.
§ 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.