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The LenSx Laser system is indicated for use:

• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.

The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.

The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.

The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

N/A

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The LenSx Laser system is indicated for use:

• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.

The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.

The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.

The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

Based on the provided FDA 510(k) Clearance Letter for the LenSx Laser System, this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new AI or novel diagnostic device.

The clearance is for a modified version of an existing device (LenSx Laser System) with software updates and an expanded indication for Implantable Collamer Lens (ICL) surgery. The general approach taken is to show that these modifications do not raise new questions of safety or efficacy and that the device remains substantially equivalent to its predicate. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/diagnostic device) is not explicitly detailed in this 510(k) summary.

However, I can extract the relevant information presented, acknowledging that it's framed within the context of demonstrating substantial equivalence for a modified device, rather than a de novo clearance for a completely new technology with novel performance claims.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable or not detailed in this type of submission:

Acceptance Criteria and Device Performance Study (as inferred from the 510(k) Summary)

The 510(k) summary indicates that the modifications to the LenSx Laser System are minor and do not introduce new safety or efficacy concerns. The "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating that the device continues to meet its intended design specifications and functional requirements, performing as intended and being equivalent to the predicate. There are no specific numerical performance metrics provided in the summary that would typically be seen for a new diagnostic or AI device (e.g., sensitivity, specificity, accuracy against a gold standard).

Table of Acceptance Criteria and Reported Device Performance

Since this is a modification to an existing device, the "acceptance criteria" are generally about maintaining the performance and safety profiles of the predicate. The "reported device performance" refers to the successful completion of the tests.

Study Details (as applicable)

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in terms of clinical cases or patient data, as no animal or clinical testing was deemed necessary for this submission. The "test set" primarily refers to bench testing, software verification/validation, and regulatory compliance checks.
   • Data Provenance: Not applicable as no clinical or animal data was collected for this submission. The data provenance for compliance testing is internal Alcon laboratories.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this 510(k) submission does not rely on expert-adjudicated ground truth from a clinical test set. The ground truth for engineering and software tests is based on design specifications, recognized standards, and regulatory guidance. For clinical ground truth, the submission relies on the established safety and efficacy of the predicate device and the assessment that the modifications do not alter this.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There was no clinical test set requiring expert adjudication.

4. 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 MRMC study was performed or required. The device is a surgical laser, not an AI-assisted diagnostic tool that would typically involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable in the context of an AI algorithm. However, the device itself, including its software, undergoes standalone functional and safety testing as part of the "Non-Clinical Testing" detailed in Section 7.1, such as "Software verification and validation testing" and "Performance Testing." These tests ensure the device (algorithm and hardware) performs its functions correctly according to specifications, independent of operator interaction after initial surgical planning.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the non-clinical and software testing, the "ground truth" is defined by:
     • Engineering Specifications: The pre-defined technical and functional requirements for the laser system.
     • International and National Standards: Compliance with standards like IEC 60601 series, ANSI Z80.36-2021 for safety and performance.
     • FDA Guidance Documents: Compliance with FDA recommendations for software documentation and cybersecurity.
     • Predicate Device Performance: The established safety and effectiveness of the existing LenSx Laser System serves as the clinical benchmark.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the typical sense for a new diagnostic algorithm. The software modifications are deterministic or rule-based enhancements (e.g., embedded calculator, new cut patterns).

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above. If there were internal development/optimization processes for the new features (e.g., nomogram calculations), their accuracy and "ground truth" would be established through mathematical validation, simulation, and bench testing against known physical principles or desired outcomes, rather than a data-driven training set.

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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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The Centurion™ Vision System (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection.

The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal.

The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof ™ lenses SN60WF. SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof ™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Alcon's CENTURION™ Vision System is an ophthalmic surgical instrument designed to provide cataract extraction using the CENTURION™ OZil™handpiece, the CENTURION™ Active Sentry™ handpiece, and the INFINITI™ OZil™ handpiece.

The CENTURION™ Vision System is intended for use in small incision cataract extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the eye, while replacing aspirated fluid and lens material with balanced salt solution (BSS™). This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration vacuum, and the flow of BSS™ irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

I'm sorry, but the provided text from the FDA 510(k) summary for the Centurion™ Vision System (Active Sentry™) (K233902) does not contain the detailed information required to answer your request.

Specifically, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details about retrospective/prospective studies.
3. Information on the number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Details about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This 510(k) summary states that the current submission (K233902) is for a modification to add a new Warning statement in the labeling for the TurboSonics™ ultrasonic tips. It explicitly states that "Non-clinical testing was previously performed in the predicate device and can be referenced in K161794." Therefore, this document focuses on demonstrating substantial equivalence based on the minor labeling change, rather than presenting new performance data from a comprehensive clinical or non-clinical study.

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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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DAILIES TOTAL 1® (delefilcon A) 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® Toric (delefilcon A) 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 6.00 diopters (D) of astigmatism.

DAILIES TOTAL 1® 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 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.

The 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.

DAILIES TOTAL 1® (delefilcon A) soft contact lenses may be made available in sphere, toric, multifocal, and multifocal toric lens designs.
The lens material, delefilcon A, is a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment.
When hydrated and placed on the cornea, DALIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.
It is considered a Group 5C material according to ISO 18369-1:2017. The lenses have a light blue tint that makes to see when handling.
The modified lenses are tinted using Reactive Blue 247.
The lenses are cast-molded and have a water gradient surface treatment. Lenses may be made available in the following parameter range:

• Diameter: 13.0 to 15.0 mm
• Base Curve: 8.0 to 9.2 mm
• Power Range: +20.0 D to -20.0 D
• Center Thickness: 0.070 mm to 0.340 mm (varies with power)
• Cylinder Power: Up to 5.00 D
• Cylinder Axis: 1° to 180°
• ADD power: Up to 5.00 D
  Moist heat sterilization is used to terminally sterilize the lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution with polymeric wetting agents that form the water gradient surface.

This document is a 510(k) Premarket Notification from the FDA regarding Alcon Laboratories' DAILIES TOTAL1® contact lenses. It addresses the substantial equivalence of modifications to the existing device.

Here's an analysis to extract the requested information regarding acceptance criteria and the study proving the device meets them:

Important Note: This FDA document approves modifications to an existing contact lens. Therefore, the "acceptance criteria" and "study" described here are primarily focused on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than proving a new device's initial safety and effectiveness from scratch. This distinction is crucial for interpreting the provided information.

1. A table of acceptance criteria and the reported device performance

Based on the document, the acceptance criteria are not presented in a formal table with specific numerical targets. Instead, the document states that the performance testing aimed to demonstrate "substantial equivalence" to the predicate device. The reported device performance is described qualitatively as "demonstrated to be substantially equivalent" and "all with passing results."

Here's a breakdown of the areas tested and the general "performance":

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state numerical sample sizes for any of the non-clinical tests (e.g., number of lenses tested for material properties, number of animals in biocompatibility studies). It only mentions that testing was conducted "using GxP conditions," referring to good x practice (e.g., Good Manufacturing Practices, Good Laboratory Practices).

The data provenance (country of origin, retrospective/prospective) is also not specified. Given the regulatory nature and the mention of GLP for biocompatibility, these studies would have been prospective and conducted according to relevant international standards.

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 or not provided in this document.

• No expert ground truth for classification/diagnosis: The testing described is primarily physical, chemical, and biological (biocompatibility) in nature for a medical device (contact lens). There is no "ground truth" in the sense of expert human interpretation of medical images or patient conditions, as would be the case for an AI diagnostic device.
• Standards-based evaluation: The "ground truth" for these tests comes from established industry standards (e.g., ISO for contact lenses, ISO 10993 for biocompatibility) and regulatory guidelines (e.g., FDA 510(k) Guidance for Class II Contact Lenses). The "experts" involved would be the testing laboratories' personnel with expertise in these specific tests and their interpretation according to the standards. Their specific qualifications and numbers are not detailed here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or human-in-the-loop performance evaluations for diagnostic devices where human experts disagree on interpretations. Here, the testing is non-clinical/laboratory-based against pre-defined physical, chemical, and biological criteria and established standards.

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. This document is for a contact lens, not an AI diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This document is for a contact lens; there is no algorithm or AI involved. The "device performance" refers to the physical, chemical, and biological properties of the contact lens itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing of this contact lens is based on:

• Established industry standards: Primarily ISO 18369-2, -3, -4 for contact lenses and ISO 10993 series for biocompatibility.
• FDA guidance documents: Specifically the May 1994 FDA guideline titled "Premarket Notification 510(k) Guidance Document for Class II Contact Lens testing."
• Prior device specifications: The modified device is compared to the predicate device to demonstrate substantial equivalence across various properties.
• GLP (Good Laboratory Practices) requirements: For biocompatibility testing (21 CFR Part 58).

So, the ground truth is standards-based and regulatory-guidance driven, ensuring the device meets pre-defined safety and performance thresholds for physical, chemical, and biological attributes, and remains equivalent to a previously cleared device.

8. The sample size for the training set

This information is not applicable. This is a physical medical device (contact lens), not a machine learning/AI model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of device.

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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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AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses with refractive power are indicated for daily wear for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

AIR OPTIX® COLORS (lotrafilcon B) toric soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

AIR OPTIX® COLORS (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear for the optical correction of presbyopia with or without refractive ametropia) in phakic or aphakic 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 of astigmatism.

AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.

The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

The lens material of AIR OPTIX® COLORS is 33% water and 67% lotrafilcon B, a fluorosilicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group 5 (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2017. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: carbazole violet, iron oxides, [phthalocyaninato (2-)] copper, phthalocyanine green and titanium dioxide.

Cleared lens designs for AIR OPTIX® COLORS (lotrafilcon B) include spherical, toric, and multifocal lenses in the following parameter range:
• 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 (0.08 mm for -3.00 D spherical)

Lenses have the following properties:
• Refractive index: 1.42 (hydrated)
• Luminous transmittance: 95 ± 5%
• Water content: 33% by weight in normal saline
• Oxygen permeability: 110 x 10-11 (cm²/sec)(ml O₂ /ml x mm Hg), measured at 35 °C (intrinsic Dk – Coulometric method)

Lenses are supplied sterile in sealed blister packs containing phosphate buffered saline solution (PBS) with 1% Copolymer 845 (labeled as buffered saline containing 0.2% VP/DMAEMA Copolymer). The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lens color, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to further extend the labeled expiration date.

The provided text describes a 510(k) premarket notification for a medical device, specifically AIR OPTIX® COLORS (lotrafilcon B) Soft Contact Lenses, and a modification to its primary packaging. It details the device, its intended use, and a comparison to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets performance criteria in the way typically expected for an AI/ML medical device.

The context of the document is a regulatory submission for a contact lens and a packaging change, not a software or AI device. Therefore, the specific information requested in the prompt related to AI/ML device evaluation (e.g., test set sample size, ground truth establishment, MRMC study, effect size, training set) is not applicable or present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device for a physical medical product and a packaging modification. The "Performance Data" section primarily addresses non-clinical testing to verify equivalence for the packaging change, rather than performance of the contact lens itself (which was previously established for the predicate).

Here's a breakdown of the relevant information provided, adapted to the context of the document:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a formal table of acceptance criteria and performance for the device itself (the contact lens) because the 510(k) is primarily for a packaging modification. Instead, it states that "Testing resulted in all acceptance criteria being met" for the packaging modification.

Acceptance Criteria and Reported Device Performance (Related to Packaging Modification)

Study Proving Device (Packaging Modification) Meets Acceptance Criteria

The study described is a non-clinical evaluation to demonstrate that the modified packaging (alternate foil lidding material from "Constantia-Pirk") does not negatively impact the safety and performance of the AIR OPTIX® COLORS contact lenses.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not explicitly stated. The document mentions "representative lotrafilcon B soft contact lenses" were used for stability, biocompatibility, and process validation testing, but does not provide specific numbers.
• Data Provenance: Not explicitly stated, but it would be from internal Alcon Laboratories, Inc. testing facilities or contracted laboratories for the specific non-clinical tests conducted. The testing is reported as "successful," implying it was conducted as part of the regulatory submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the submission is for a physical medical device (contact lens) and a packaging change, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The evaluation relied on scientific and engineering testing for stability, biocompatibility, and process validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a contact lens packaging modification. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts, which is not the nature of this submission. The "adjudication" here would be the scientific review and approval of the test results by qualified personnel within Alcon and subsequently by the FDA.

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 is not applicable as the device is a contact lens, not an AI-assisted diagnostic tool. No human readers or AI assistance are involved in the performance evaluation described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to AI/ML devices is not applicable here. For this submission, the "truth" is established by adherence to validated scientific and engineering testing methods for characteristics like material stability, sterility, and biocompatibility, as outlined in relevant standards and guidelines (e.g., FDA guidance for contact lenses, ISO standards).

8. The sample size for the training set

This is not applicable as the device is a contact lens and not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a contact lens and not an AI/ML model.

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The CLAREON MONARCH IV IOL Delivery System is for implantation of qualified Alcon foldable IOLs. No unqualified lenses should be used with the CLAREON MONARCH IV IOL Delivery System.

The CLAREON MONARCH IV IOL Delivery System consists of two parts. An autoclavable, reusable, titanium handpiece and a sterile, single-use cartridge are used for implanting foldable intraocular lenses into the eye following removal of the natural crystalline lens.

The system provides a controlled means to reliably place Alcon qualified intraocular lenses (IOLs) into the capsular bag when a qualified combination of handpiece, cartridge, Alcon foldable IOL, and ophthalmic viscosurgical device (OVD) is used.

The cartridge is loaded by inserting the IOL into the opening in the back of cartridge after OVD is applied to the inner lumen of the cartridge. The loaded cartridge is installed into the handpiece and the IOL is delivered through the cartridge nozzle.

The provided text describes a 510(k) summary for the CLAREON MONARCH IV IOL Delivery System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI/software device would.

The information given relates to a hardware medical device (an intraocular lens delivery system), not an AI-powered diagnostic or predictive tool. Therefore, many of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," or "ground truth for training set") are not applicable to this type of device and are not present in the provided text.

However, I can extract the relevant information regarding performance testing and acceptance criteria as described for this hardware device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards and characteristics tested to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these standards and demonstrating equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test mentioned (e.g., how many IOLs were delivered, how many sterilization cycles were performed for specific tests). It only lists the types of tests conducted. "Data provenance" as in country of origin or retrospective/prospective is not specified, as these are typically bench and lab tests for a physical device, not an imaging or diagnostic study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The testing described involves engineering, material, and biological compatibility assessments against established standards, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This is not applicable and not provided as it's not a study involving human interpretation of data for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is compared. The described device is a physical delivery system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This is a hardware device; thus, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established international standards (ISO, IEC) and FDA guidance documents for medical device performance, biocompatibility, reprocessing, and human factors. For example:

• IOL Delivery Performance: Compliance with ISO 11979-3-12.
• Biocompatibility: Conformance to ISO 10993-18-20 and ISO 10993-5-09.
• Reprocessing and Sterilization: Adherence to ISO 17664-17, ISO 17665-1-06, and ISO 14937-09.
• Human Factors: Conformance to IEC 62366-1-20 and FDA guidance.

8. The Sample Size for the Training Set

No training set is applicable or mentioned. This is a physical device, not a machine learning model.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.

The DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.

The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high and ultra-high molecular weight PVA and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.

DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).

The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.

The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.

This document describes the 510(k) submission for Alcon Laboratories, Inc.'s DAILIES AquaComfort Plus contact lenses, focusing on an extension of their expiration dating. As such, the study described is primarily related to shelf-life stability and not clinical performance or artificial intelligence (AI) device performance. Therefore, many of the requested categories are not applicable (N/A) or cannot be extracted from this document, as it does not describe a clinical performance study with human readers or an AI algorithm.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

This document does not specify a distinct "test set" in the context of an AI algorithm or traditional clinical trial. The testing performed was primarily non-clinical stability testing.

• Sample Size: Not explicitly stated for stability testing within this document. Stability studies involve testing multiple samples over time.
• Data Provenance: The document implies in-house testing by Alcon Laboratories, Inc., as part of the manufacturing and regulatory compliance process. The country of origin of the data is not specified beyond Alcon's location (Fort Worth, TX for the company, and the contact person in Germany). The data is retrospective in the sense that it's gathered over time as part of a stability study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

N/A. This submission focuses on shelf-life and biocompatibility, not clinical expert-based ground truth for device performance in diagnosis or image interpretation.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically employed in clinical studies or for ground truth establishment for AI where multiple experts might disagree. This is not relevant to the non-clinical stability testing described.

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

N/A. This device is a contact lens, and the submission is for an extended shelf-life. There is no AI component or human reader comparative effectiveness study involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This is not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Shelf-life: The "ground truth" is derived from established laboratory testing protocols and standards for contact lens stability (e.g., measuring physical and chemical properties over time).
• Biocompatibility: The "ground truth" is based on recognized in vitro cytotoxicity testing methods (Cell Growth Inhibition and Modified ISO/USP Elution methods) and their pre-defined acceptance criteria for biocompatibility, often benchmarked against predicate devices or regulatory standards.

8. The Sample Size for the Training Set

N/A. There is no AI model or training set described.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable as there is no AI model or training set.

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