(56 days)
Precision1 (verofilcon A) Spherical and Precision1 Asphere (verofilcon A) 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 non-diseased eyes and 6.00 diopters (D) or less of astigmatism.
Precision1 Multifocal (verofilcon A) multifocal soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and have up to approximately 1.50 diopters of astigmatism.
Precision1 Multifocal Toric (verofilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myoeropia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.
The lenses are to be prescribed for single use, daily disposable wear, 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.
The subject device, Precision1™ (verofilcon A) soft contact lenses, are made from a silicone containing hydrogel lens material that is approximately 51% water and 49% verofilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue edge-to-edge color to make it easier to see when handling. In addition, lenses contain a benzotriazole UVabsorbing monomer to block UVA and UVB radiation.
Verofilcon A represents a Group V silicone hydrogel contact lens material ('enhanced oxygen permeable materials') according to ISO 18369-1:2006/Amd.1:2009 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications. The 2017 revision of the standard further classifies silicone hydrogels into subgroups. According to ISO 18369-1:2017 the verofilcon A silicone hydrogel material is in the soft contact lens material group classification as follows: Group Suffix 5B, Hydrogel Material High water subgroup, Description A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8.
Verofilcon A lens designs include spherical, asphere, toric, multifocal and multifocal toric lenses in the following parameter ranges: Diameter Range: 13.0 to 15.0 mm, Base Curve Range: 8.0 to 9.2 mm, Power Range: -20.00 D to +20.00 D, Center Thickness: varies with design and power (Example: 0.09 mm for -3.00 D spherical).
Lenses have the following properties: Refractive index: 1.4 (hydrated), Water content : 51% by weight in normal saline, Oxygen permeability: 90 x 10 -11 . [(cm2 /sec)(ml O2 /mlommHg)] measured at 35 °C (intrinsic Dk-Coulometric method), Light transmittance: > 90 %, UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 nm for the entire power range.
Verofilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with approximately 0.3% of polymeric wetting agents consisting of copolymers of polyamidoamine and poly (acrylamide-acrylic) acid.
The provided text describes the 510(k) premarket notification for the Precision1™ contact lenses (verofilcon A). It details the device, its comparison to a predicate device, and the testing conducted to demonstrate its substantial equivalence, including nonclinical and clinical performance testing. However, the document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., minimum accuracy percentages, sensitivity, specificity thresholds) that the device must meet. Instead, the study aims to demonstrate "similar clinical performance" and "substantial equivalence" of the Precision1™ lens compared to the predicate device (Alcon® DAILIES TOTAL1®).
Therefore, I cannot provide a table of acceptance criteria with specific numeric thresholds as they are not explicitly stated in the document. The document focuses on demonstrating comparable safety and performance.
Here's an analysis of the study information based on your request:
Acceptance Criteria and Study for Precision1™ (verofilcon A) Contact Lenses
As stated above, the document does not explicitly list quantitative acceptance criteria with specific performance thresholds. Instead, the primary goal of the clinical study was to demonstrate substantial equivalence and similar clinical performance between the subject device (Precision1™) and the predicate device (Alcon® DAILIES TOTAL1®) in terms of safety and efficacy.
The "acceptance criteria" can be inferred to be the demonstration of non-inferiority or comparable performance in the following areas:
| Acceptance Criteria (Inferred) | Reported Subject Device Performance |
|---|---|
| Safety: No adverse impact on ocular health compared to predicate device. | "A series of in vitro and in vivo biocompatibility evaluations...confirm that verofilcon A contact lenses are non-toxic and biocompatible." |
| "Product safety was assessed based on adverse events, device deficiencies and biomicroscopy findings." | |
| "The study results showed similar clinical performance between the test verofilcon A and control delefilcon A lenses in the clinically relevant areas of vision, comfort, fit, handling and health..." | |
| "The risks of the subject device are the same as those normally attributed to the wearing of silicone hydrogel contact lenses..." | |
| Performance (Vision): Comparable visual acuity to predicate device. | "The primary effectiveness endpoint was logMAR VA at distance." |
| "Additional endpoints include refraction, keratometry, lens fit, surface characteristics and subjective ratings of vision..." | |
| "The study results showed similar clinical performance between the test verofilcon A and control delefilcon A lenses in the clinically relevant areas of vision..." | |
| Performance (Comfort): Comparable comfort to predicate device. | "Additional endpoints include...subjective ratings of...comfort..." |
| "The study results showed similar clinical performance between the test verofilcon A and control delefilcon A lenses in the clinically relevant areas of...comfort..." | |
| Performance (Fit & Handling): Comparable fit and handling characteristics to predicate device. | "Additional endpoints include...lens fit, surface characteristics and subjective ratings of...handling." |
| "The study results showed similar clinical performance between the test verofilcon A and control delefilcon A lenses in the clinically relevant areas of...fit, handling..." | |
| Technological Characteristics: Similar material properties and design to predicate device, with differences not adversely affecting safety/effectiveness. | Nonclinical bench testing established physicochemical properties (e.g., refractive index, oxygen permeability, water content, mechanical properties, transmittance). |
| "Any differences which may exist between the subject device (verofilcon A soft contact lenses) and the predicate device or other daily disposable, silicone hydrogel soft contact lenses do not adversely affect the safety and effectiveness of the subject device." |
Here's the detailed information about the study:
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Sample size used for the test set and the data provenance:
- Sample Size: A total of 107 subjects (214 eyes) were enrolled. Of these, 105 subjects completed the study. There were 69 subjects in the verofilcon A (test) group and 36 subjects in the delefileon A (control) group (2:1 ratio).
- Data Provenance: The study was conducted at six (6) study sites in the US. It was a prospective, randomized, stratified, controlled, double-masked, parallel group study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a clinical study involving human subjects wearing contact lenses, not an AI or diagnostic device study requiring "expert" establishment of ground truth in the traditional sense. The "ground truth" for clinical endpoints like visual acuity, comfort, fit, and ocular health was established through direct measurement and assessment by eye care professionals (presumably optometrists or ophthalmologists at the study sites) and subjective feedback from the subjects themselves. The document does not specify the number or specific qualifications of these clinicians, beyond implying they are "eye care professionals."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document states it was a double-masked study. This means that neither the subjects nor the investigators/assessors knew which lens (test or control) each subject was wearing. This masking serves as a form of bias reduction during assessment, but it is not an adjudication method in the sense of multiple experts reviewing and reaching consensus on findings (like 2+1 or 3+1). The "adjudication" of outcomes would have been based on direct clinical measurements and standardized subjective questionnaires.
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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:
- No, this was not an MRMC study, nor does it involve AI assistance for human readers. This study evaluated the performance of a medical device (contact lenses) worn directly by subjects, not a diagnostic imaging device interpreted by human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this was not an AI algorithm standalone performance study. It was a clinical trial evaluating the performance of a physical medical device (contact lenses) in human subjects.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for efficacy was based on direct clinical measurements (e.g., logMAR VA, refraction, keratometry, biomicroscopy findings for ocular health, lens fit) and subjective reports from the patients (e.g., comfort, vision, handling). For safety, adverse events and device deficiencies were monitored. This is effectively a form of outcomes data directly collected from the subjects.
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The sample size for the training set:
- This was a clinical trial comparing a new device to a predicate, not an AI study involving a training set. Therefore, there is no "training set" in this context. The nonclinical testing serves a similar purpose of characterizing the device properties before clinical evaluation.
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How the ground truth for the training set was established:
- As there was no training set for an AI algorithm, this question is not applicable. The device's characteristics were established through nonclinical (biocompatibility, physical-chemical) testing and then validated in the clinical comparative 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.