(53 days)
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is made from nesofilcon A material, a hydrophilic copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone. The lens is 78% water by weight when immersed in a sterile borate buffered saline with poloxamine solution. A UVabsorbing 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. The lenses are tinted blue for visibility with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106.
The 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 lens will be manufactured in the following parameter ranges:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Powers: -0.75D to -5.00D
Cylinder Axis: 0° to 180°
The lens is packaged in disposable blister packages containing borate buffered saline solution with poloxamine and provided sterile. Blister packages are labeled with the lot number, expiration date and applicable lens parameters.
The provided document describes the Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device.
However, interpreting the request to extract information about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this contact lens submission, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" in the way one might expect for an AI/ML device (e.g., target accuracy metrics). Instead, it lists physical properties and functional characteristics that the device is designed to meet, which serve as its "performance." The comparison is made against the predicate device.
| Property/Characteristic | Acceptance Criteria (Implied from Predicate/New Device Specifications) | Reported Device Performance (New Device) |
|---|---|---|
| Material Group | Group II (high water, no ionic polymers) | Same as predicate (Group II) |
| USAN Name | nesofilcon A | Same as predicate (nesofilcon A) |
| Water Content | 78% | 78% |
| UV Blocker | Present | Present (transmittance |
§ 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.