(102 days)
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.
The provided document is a 510(k) premarket notification for a contact lens, the "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies typical for novel medical devices or AI algorithms. As such, the information you're requesting regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training sets is not applicable to this document.
The "study that proves the device meets the acceptance criteria" in this context refers to a series of preclinical (non-clinical) tests and a comparison to a predicate device, rather than human clinical trials or AI performance evaluations.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this contact lens submission, the "acceptance criteria" are not framed as specific performance thresholds for an AI algorithm's metrics (like sensitivity, specificity, or AUC). Instead, they are demonstrated through equivalence to a legally marketed predicate device and through non-clinical testing that proves the device meets established standards for contact lens safety and function.
The table below summarizes the key comparative data provided for the subject device and its predicate, which implicitly defines the "acceptance criteria" through equivalence.
| Item | Predicate Device (K020927) BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (Reported Performance) | Acceptance Criteria (Implicitly, Equivalence to Predicate) |
|---|---|---|---|
| Regulatory Number | 886.5925 | 886.5925 | Same as predicate |
| Classification | II | II | Same as predicate |
| Intended Use | Daily wear for correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less. | Daily wear for correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less. | Similar to predicate, with some indication differences that do not raise new safety/effectiveness concerns. |
| Prescription Use | Yes | Yes | Yes |
| Material | polymacon | polymacon | polymacon |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 38% | 38% | 38% |
| Powers | $\pm 20.00D$ | $-0.50D \sim -12.00 D$ | Demonstrated range is acceptable and supported by material properties. |
| Light Transmittance | $\ge 96%$ | $95% \pm 5%$ | Comparable to predicate. |
| UV-A | - (Not specified in table) |
§ 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.