(224 days)
The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.
The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibilityhandling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name,
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a coloriess, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:
Refractive Index at 21ºC: 1.4011(wet)
Light Transmission: > 95%
Surface Character: Hydrophilic
Water Content at 21ºC: 59.77 %
Specific Gravity at 21ºC: 1.086(wet)
Oxygen Permeability at 34-36°C: 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).
The provided text describes a 510(k) summary for a soft contact lens and does not contain information about a study that tests the device against acceptance criteria in the context of AI/medical imaging performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a device performance study.
The document is a regulatory submission for a contact lens, which is a physical medical device, not an AI or imaging diagnostic tool. The "acceptance criteria" discussed in such a submission would typically relate to manufacturing specifications, material properties, and clinical safety/performance in human trials (bio-compatibility, visual acuity achieved, adverse event rates), rather than statistical metrics like sensitivity, specificity, or F1-scores derived from an AI model's output compared to ground truth.
Specifically, the document states:
- "The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate devices: Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp. and Clear All Day (hioxifilcon A), K052290, Manufactured by Clearlab SG Pte Ltd."
- The comparison is made on "Technological Characteristics" such as intended use, functionality, indications, production method, FDA group #, USAN name, water uptake (%), oxygen permeability (Dk), and specific gravity (wet).
These are not acceptance criteria or performance metrics related to an AI device's diagnostic accuracy.
§ 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.