(194 days)
The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and notaphakic persons with non-diseased eyes.
The HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens is available as a spherical or astigmatic (toric) lens. The lens material, methafilcon B, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. When placed on the cornea in its hydrated state the HYDRASOFT (East) Contact Lens act as a refracting medium to focus light rays on the retina.
The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it relates to a medical device's diagnostic performance. Instead, the document is a 510(k) summary for a contact lens, focusing on its substantial equivalence to a legally marketed predicate device based on manufacturing processes and material properties.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, expert involvement, or statistical analyses for diagnostic performance.
The document mainly discusses:
- Device Name: HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens
- Intended Use: Daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and notaphakic persons with non-diseased eyes.
- Technological Characteristics: Stated to be the same as the predicate device, Hydrasoft® and Hydrasoft® Toric.
- Non-Clinical Tests: Physical and chemical properties testing (water content, light transmittance, refractive index, mechanical properties) and toxicity tests (Systemic Injection Test and Cytotoxicity Test). These tests were performed to establish equivalence to the predicate device due to an alternate manufacturing method and polymerization process, not to evaluate diagnostic performance.
- Conclusion: Substantial equivalence is based on the results of non-clinical testing demonstrating that lenses manufactured with the alternate method are equivalent to currently marketed Hydrasoft® and Hydrasoft® Toric contact lenses, having the same design, indication, and directions for use.
In summary, the provided text does not offer the type of information requested about diagnostic device acceptance criteria and performance studies.
§ 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.