(52 days)
The BOSTON® EQUALENS® II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes.
The lens may be disinfected using a chemical disinfection system only.
The BOSTON® EQUALENS® II (oprifocon A) is a Rigid Gas Permeable Contact Lens material composed of methyl methacrylate fluoroitaconate siloxanyl copolymer with an ultraviolet absorber.
The color additives conform to 21 CFR Part 74. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
Property: Specific Gravity, BOSTON EQUALENS II: 1.24
Property: Refractive Index, BOSTON EQUALENS II: 1.423
Property: Light Absorbance (Absorbance Units/Inch), BOSTON EQUALENS II: 9.4 Blue, 4.8 Green
Property: Water Content, BOSTON EQUALENS II:
The provided text describes a 510(k) summary for the BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance evaluation.
Instead, this document is a regulatory submission for a medical device (contact lenses) based on substantial equivalence to a predicate device. This means the manufacturer is asserting that their new contact lens is as safe and effective as a previously approved contact lens, based on its physical/optical properties and intended use.
Therefore, I cannot fulfill your request for information related to acceptance criteria, device performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text, which pertains to a traditional medical device approval process, not an AI/ML device evaluation.
The text does give information on:
- Device Description: Physical/optical properties of the lens material.
- Indications for Use: What the contact lens is intended to correct.
- Predicate Device: The existing device to which the new device is compared for substantial equivalence.
- Regulatory Status: The FDA's determination of substantial equivalence.
Without details on an AI/ML device and its associated performance study, I cannot generate the requested table or paragraphs.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.