(10 days)
FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.
The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively. The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.
The provided text is a 510(k) Summary for the FreshLook® Bifocal UV-absorbing Contact Lenses. It details the device's characteristics and its equivalence to a predicate device but does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
The document states, "Reference PMA Supplement P830037/S042 Exhibit IV-1, Exhibit IV-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table of the FreshLook Bifocal UV-absorbing Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lonses submitted to the agency for Real Time Review," and refers to this PMA Supplement for "technological device characteriatios" and "manufacturing." This suggests that the detailed study data regarding acceptance criteria and performance might be located in the referenced PMA Supplement, which is not part of the provided text.
Therefore, for the FreshLook® Bifocal UV-absorbing Contact Lenses, based only on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The document lists physical properties but not against specific acceptance criteria in a performance study context.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not available in the provided document. As this is a physical contact lens, expert adjudication in the manner of diagnostic AI is not directly applicable. However, clinical trial data would involve ophthalmologists or optometrists, but details are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable as the device is a contact lens and not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a contact lens and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided document. For contact lenses, "ground truth" would typically refer to established clinical endpoints and measurements (e.g., visual acuity, comfort, fit, physiological response of the eye), but no details of such studies are included here.
8. The sample size for the training set:
This information is not applicable as the device is a physical contact lens, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical contact lens, not an AI model.
Summary of available information from the document:
The 510(k) summary focuses on the device's description, its intended use, and its substantial equivalence to a predicate device (FreshLook® UV). It details the physical properties and range of parameters for the contact lenses. The approval letter confirms that the device is "substantially equivalent" to legally marketed devices, allowing it to proceed to market. The basis for this equivalence and any specific performance studies with acceptance criteria appear to be contained in the referenced PMA Supplement P830037/S042, which is not provided in this text.
§ 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.