(51 days)
The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the 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 SAUFLON 55UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lenses for Daily Wear is available as a single vision lens in an aquamarine visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the Inns consists of 45.0% HEMA and 55.0% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with: Reactive Blue No. 4 and Reactive Yellow Dye # 86. A benzophenone UV absorbing monomer is used to block UV radiation.
The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380mm.
The SAUFLON 55 UV Contact Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.
The provided text describes specific information about a contact lens and its comparative testing. However, it does not include the details requested in your prompt regarding acceptance criteria for a device performance study, the study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information.
Instead, the document focuses on:
- Device Description: SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear.
- Substantial Equivalence Claim: To FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lenses, based on physical and optical properties.
- Preclinical Testing: Toxicology, residual monomer, and color leachability to demonstrate non-toxicity and non-irritation.
- Physical/Optical Property Comparison Table: Between the SAUFLON 55 UV and the predicate device, FREQUENCY 55. This table presents performance metrics but these are not explicitly framed as "acceptance criteria" for a study in the context of the prompt's request.
- Indications for Use: Correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes; daily wear in a Frequent Replacement Program; disinfection compatibility.
- Transmittance Curves: Showing UV blocking characteristics compared to human cornea and crystalline lens.
Therefore, I cannot populate the table or provide the detailed study information as requested because the document does not contain that specific type of performance study data or acceptance criteria. It primarily relies on demonstrating substantial equivalence through material properties and basic preclinical safety tests.
§ 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.