(146 days)
The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.
The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.
The provided document is a 510(k) Pre-market Notification for a contact lens, the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens. It details the device's properties and its substantial equivalence to a predicate device. This type of regulatory submission does not typically include information about studies to prove device performance against acceptance criteria in the same way a software or AI/ML device would.
Instead, for contact lenses, "acceptance criteria" are usually based on demonstrating that the new device has equivalent or better physical, optical, and chemical properties, as well as safety (toxicology, leachable compounds), compared to a previously cleared predicate device. The "study" proving this involves direct comparison of these properties through laboratory testing, rather than clinical trials with human readers or AI performance metrics.
Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size) are not applicable to this type of device and submission.
Here's an attempt to answer the questions based on the provided text, recognizing the different nature of this device type:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to the predicate device, FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear. This is achieved by showing comparable physical, optical, and chemical properties, and acceptable safety profiles.
| Parameter | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (FREQUENCY 55 UV) | Predicate Device Performance (FREQUENCY 55) |
|---|---|---|---|
| Material | methafilcon A | methafilcon A | methafilcon A |
| Indication for use | myopia, hyperopia, astigmatism | myopia, hyperopia, and astigmatism | myopia, hyperopia, and astigmatism |
| Water Content | 55% | 55% | 55% |
| % Transmittance @ 590nm | Comparable to Predicate (>90% specified in description) | 93.58% | 95.47% |
| % Transmittance @ 280-315 nm | Block UV (significantly lower than predicate, |
§ 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.