(213 days)
The SportSight GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight GP (paflufocon C) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. SportSight GP bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight TM GP (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The SportSight GP (paflufocon C) intensely tinted, rigid gas permeable contact lenses are available in SportSight Gray. The Gray tinted lens contains D&C Red # 17, D & C Green No. 6, and Perox Yellow No. 9. The lenses have the following dimensions: Refractive Index 1.466(Nd at 25°C), Luminous Transmittance (driving allowed) 8% - 26%, Luminous Transmittance (driving prohibited) 1% - 8%, Wetting Angle (Receding Angle) 12.81 1.14, Specific Gravity, Hardness (Shore D) 84,
The provided text describes the technical specifications and testing of "SportSight™ GP (paflufocon C)" rigid gas permeable contact lenses, but it does not contain information about a device that uses artificial intelligence (AI) or a study that evaluates its performance against acceptance criteria in the context of AI/ML.
Instead, the document is a 510(k) submission for a traditional medical device (contact lenses) and focuses on demonstrating substantial equivalence to a predicate device and compliance with physical and safety standards. The "acceptance criteria" discussed are product specifications (e.g., light transmittance, UV blocking, material properties) and the "study" is primarily physical testing and biocompatibility assessments, not performance evaluations of an AI algorithm.
Therefore, I cannot provide the requested information about AI acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text.
The information that is available about the device's properties and testing is presented below, aligning with the format requested where applicable for such a device:
Acceptance Criteria and Device Performance (SportSight™ GP Contact Lenses)
The acceptance criteria for the SportSight™ GP contact lenses are primarily based on optical properties and material characteristics, benchmarked against standards like ANSI Z80.3-1996 for Nonprescription Sunglasses and Fashion Eyewear. The study demonstrates that the device meets these criteria through laboratory measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The following table summarizes key performance characteristics based on various lens powers and associated center thicknesses ("Lower", "Recom" - recommended, "Upper", and "Special*"). The acceptance criteria are implicit in the reported values meeting the specified ranges and standards.
| Characteristic | Acceptance Criteria (e.g., ANSI Z80.3-1996) | Reported Device Performance (Range across power/thickness variations) |
|---|---|---|
| Luminous Transmittance (%) | Driving Allowed: 8% - 26% (based on specific thickness, lower transmittance for thicker lenses) | For driving allowed lenses: 8% - 26% |
| Driving Prohibited: 1% - 8% (for special prescription lenses with thickness beyond safe driving limit) | For driving prohibited lenses: 1% | |
| UV Mean Transmittance UVB (290-315 nm) | Minimum 99% reduction of UVA and UVB entering the eye (implies |
§ 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.