(172 days)
Bausch + Lomb nesofilcon A contact lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D.
The nesofilcon A contact lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The Bausch + Lomb contact lens is made from nesofilcon A material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 78% water by weight when immersed in a sterile borate buffered saline with 0.5% poloxamine solution. This packaging solution is currently used with other Bausch + Lomb contact lenses. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106.
The Bausch + Lomb nesofilcon A contact lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
Refractive index: 1.374
Light transmission: 99%
Water Content: 78%
Specific Gravity: 1.039
Oxygen Permeability: 42 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method)
The lenses will be manufactured with the following properties:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
The lenses are packaged in disposable blister packages containing borate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters measurement. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.
The provided text describes the 510(k) premarket notification for the Bausch + Lomb nesofilcon A contact lens. It details the device's characteristics, intended use, and a comparison to a predicate device. However, it does not contain the specific information required to complete a table of acceptance criteria with reported device performance for a medical device that uses AI/ML based on the prompt's structured request for such studies.
Specifically, the document pertains to a physical medical device (contact lens) and not an AI/ML-based diagnostic or treatment system. Therefore, details like multi-reader multi-case (MRMC) studies, sample sizes for test sets in an AI context, expert ground truth establishment, adjudication methods, or standalone algorithm performance are not applicable and thus not present in the provided text.
The information provided does offer a "Summary of Non-Clinical Testing" and "Summary of Clinical Performance Data" but these are for the contact lens itself and do not align with the structure of acceptance criteria and study details for an AI-based device as requested. The non-clinical testing involved biocompatibility, chemistry, and physical/chemical properties, while the clinical study compared the new contact lens to a predicate device for safety and efficacy.
Therefore, I cannot fulfill your request for the specific AI/ML-related acceptance criteria and study details.
§ 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.