(70 days)
The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity.
The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less.
OSPREY™ Spherical or Toric (hioxifilcon B) Multifocal Soft Daily Wear Contact Lenses (Clear and Blue Visibility Tint, Lathe-cut from Lens Blanks) are made from clear and a blue visibility tint BENZ-G 3X (hioxifilcon B) lens blanks intended for daily wear for correction of visual acuity of aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses are manufactured by lathe-cutting of lens blanks in dry (i.e. non-hydrated) state into hemispherical shell which can be polished when desired. The toric contact lens have a Toric Base Curve.
Osprey™ Multifocal Soft Contact Lens is a center-distance, simultaneous-focus, progressive-addition lens. Focal power within the central power zone is generated on the front surface, beginning at the central distance power, and increasing radially outward. Labeled Add Power is that Add Power which is occurring at the pupillary zone diameter of 3.5 mm. The back surface may be either spherical or toric for correcting astigmatism. The toric lens is held on axis by the superior and inferior front surface flanges, formed by slab-off. The lenses are available in clear and with a blue visibility tint as supplied by the manufacturer of lens blanks.
This document is a 510(k) Premarket Notification for a medical device – contact lenses. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/algorithm-based medical device.
The provided text describes:
- Device: OSPREY™ Spherical and Toric (hioxifilcon B) Multifocal Soft Daily Wear Contact Lenses.
- Purpose of document: To demonstrate substantial equivalence to previously cleared devices, not to present a clinical study with detailed performance metrics against acceptance criteria for a new, AI-driven diagnostic or treatment device.
- Information provided relates to:
- Applicant, manufacturer, and contact details.
- Device classification and names.
- Comparison to predicate devices (UltraVue/P and UltraVue/C) based on material, manufacturing, and general intended use, rather than a performance study measuring specific clinical outcomes with acceptance criteria.
- Physicochemical properties of the lens material (Table 4) are presented, but these are material properties, not performance metrics derived from a clinical study with human subjects.
- Intended use and a description of the device's optical design.
- A letter from the FDA confirming substantial equivalence based on the submitted notification.
Therefore, I cannot provide the requested information because the document does not describe such a study.
To answer your prompt, I would need a different type of document, such as a clinical study report or a 510(k) summary for an AI/algorithm-based diagnostic device that includes a detailed validation study.
§ 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.