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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 or aphakic persons with nondiseased eyes and 6.00 diopters (D) or less of astigmatism.

Precision1 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.

Dailies Total1 (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Dailies Total1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia. with or without refractive ametropia (myopia and hyperopia) 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 approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

Dailies Total1 for Astigmatism (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.

Dailies Total 1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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.

Dailies Total1 lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Precision1 (P1) (verofilcon A lens material) and Dailies Total1 (DT1) (delefilcon A) are soft contact lenses, intended for on-eye use in persons with healthy eyes that need vision correction as determined and fitted by an eye care professional. The lensed for single use, daily disposable wear (less than 24 hours while awake) only.

Precision1 (verofilcon A) and Dailies Total1 (delefilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foil-blister 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 packs are packaged into carton boxes available in different pack sizes.

Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric (for astigmatism) lens design.

Dailies Total 1 (delefilcon A) soft contact lenses are available in spherical, toric (for astigmatism) and multifocal toric lens designs.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for Alcon's contact lenses (Precision1 and Dailies Total1 families). It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• The general controls and regulations applicable to the devices.
• The indications for use for the various contact lens products.
• A summary of the device description and intended use.
• A statement that the submission is for a manufacturing change (modification of extraction and coating processes) and that no clinical testing was required to establish safety and effectiveness for this specific change. Instead, non-clinical bench testing demonstrated that the lenses meet established finished product specifications and are substantially equivalent to the predicate devices.

Therefore, I cannot fulfill your request as there is no information in the provided text regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

These elements are typically found in documents describing clinical trials, performance studies for AI/ML-driven devices, or detailed design verification and validation reports, none of which are present in this FDA 510(k) clearance letter.

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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 eves 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 nondiseased eyes and 6.00 diopters (D) or less of astigmatism.

Precision1 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.

TOTAL30 (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

TOTAL30 for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction ofrefractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes with up to 6.00 diopters (D) of astigmatism.

TOTAL30 Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) 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 approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

TOTAL30 lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.

Precision1 (verofilcon A) soft contact lenses are currently available in a spherical and a toric lens design.

Precision1 (verofilcon A) soft contact lenses are supplied sterile, immersed in buffered saline solution and packaged in individual foilblister packs, which are terminally sterlized 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.

Lehfilcon A soft contact lenses are available in a spherical design (for correction of vision in persons with myopia or hyperopia), toric design (for correction of myopia, with astigmatism) and multifocal design (for correction of presbyopia, with or without myopia or hyperopia) in a range of powers and parameters.

Lehfilcon A lenses immersed in package saline and provided sterile in sealed blister packages are fully functioning (i.e., ready to use) out of pack (no need for accessories). Lenses in sealed blister packs (primary packaging) are provided in an outer carton (secondary packaging). For daily wear/reuse, products such as commercially available soft contact lens care cleaning and disinfecting solutions, rewetting drops, saline solutions and contact lens cases may be used. Accessories are sold and provided separately from the device.

The provided FDA 510(k) clearance letter and summary for Alcon's contact lenses (Precision1, TOTAL30, etc.) do not contain any information about an AI/ML-driven medical device, a study involving AI assistance, or acceptance criteria related to a device's performance based on AI algorithms.

The document discusses soft contact lenses and their indications for use, and the 510(k) submission relates to:

• The "Trade/Device Name" and "Regulation Number/Name" for contact lenses.
• The legal basis for marketing these contact lenses based on substantial equivalence to predicate devices.
• Quality System (QS) regulations for manufacturing medical devices.
• Indications for Use for various contact lens types.
• A 510(k) summary indicating "no proposed device modifications related to this change only affects quality control measures." This means the submission is likely for a minor manufacturing or quality control change to existing contact lens products, not a new or modified AI device.

Therefore, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving an AI device's performance, as this information is not present in the provided text. The prompt's questions pertain to AI/ML device validation, which is unrelated to the content of this FDA document for contact lenses.

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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

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.

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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:

Here's the detailed information about the study:

2. 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.

3. 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."

4. 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.

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:

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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