(29 days)
Precision1 (verofilcon A) Spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
The lenses are to be prescribed for single use, as recommended by the eye care professional. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric lens design.
Precision1 (verofilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Precision1 for Astigmatism (verofilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism.
Precision 1 (verofilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foilblister packs, which are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The foil-blister pack system consists of a polypropylene (PP) blister shell sealed with a coated aluminum foil lidding. The blister packaged into carton boxes available in different pack sizes.
This document describes the 510(k) premarket notification for the Precision1 and Precision1 for Astigmatism soft contact lenses. The submission is for a modification to an already legally marketed predicate device (Precision1 for Astigmatism, K182902). The modification involves adding foil from an alternate supplier for primary packaging and extending the product expiration dating from 72 to 84 months.
The document states that the scope of the device modification did not require clinical testing to establish safety and effectiveness. Therefore, the information typically associated with studies proving device performance against acceptance criteria (such as sample sizes, ground truth establishment, expert adjudication, or MRMC studies) is not present in this document. The device stability and process validation were completed to verify equivalence to the predicate device.
Here's the information that could be extracted from the document regarding acceptance criteria and the study, as much as applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: Successful stability testing (to ensure product integrity over extended shelf life) | All acceptance criteria being met. |
| Equivalence to Predicate Device: Process validation (to ensure manufacturing consistency and sterilization efficacy) | All acceptance criteria being met. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as part of a clinical study. The document refers to "stability testing" and "process validation," which are typically laboratory-based tests.
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 applicable as the document states that clinical testing was not required for this submission. The "ground truth" for the non-clinical tests would be defined by pre-established scientific and engineering standards for stability and process validation, not by human expert consensus or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical test set requiring expert adjudication.
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
There was no MRMC comparative effectiveness study done. This submission is for a material and shelf-life extension change to an existing contact lens, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this device is a contact lens, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical "stability testing" and "process validation," the ground truth would be established by scientific and engineering specifications and standards for contact lens materials, sterility, and performance over time. This is not medical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable as there was no training set for an algorithm or AI.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for an algorithm or AI.
§ 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.