Search Results

Spherical: ProSoft™ Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.00 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

Toric: ProSoft™ Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The Spherical and Toric lenses may be prescribed for daily wear in not-aphakic or aphakic persons. The eye care practitioner may prescribe the lens with routine cleaning, rinsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

ProSoft Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are hemispherical shells of the lens material (phemfilcon A), which is a hydrophilic copolymer of 2hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate.

Once cured the rods are cut to buttons and then lathed to the proper spherical or toric configuration. The ProSoft contact lenses are made by adding Vat Green #1 dye to the finished lens using the CTL (custom tinting) process.

Prosoft lenses enhance perception of colored objects relative to other background colors. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye, on the tennis court, golf course or other background.

This document does not describe an AI medical device or a study involving an AI algorithm. Instead, it is a 510(k) premarket notification for a traditional medical device: "ProSoft Spherical and Toric (phemfilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear."

The document details the device's indications for use, its physical and mechanical properties, toxicology, and compares it to predicate devices to establish substantial equivalence. It does not mention any artificial intelligence, machine learning, or automated diagnostic capabilities.

Therefore, I cannot extract the information required for an AI-specific study report, as the provided text relates to a conventional contact lens and its regulatory clearance process.

To directly answer your numbered points based on the provided text, if we were to interpret "device performance" in a general sense for a medical device rather than an AI device:

1. A table of acceptance criteria and the reported device performance:
   The document establishes "substantial equivalence" as the primary acceptance criterion, comparing the ProSoft lenses to predicate devices. Specific quantitative acceptance criteria or detailed performance metrics are mentioned in the context of physical, mechanical, and safety properties but not in a consolidated table format with explicit acceptance criteria vs. results.

   Performance Aspect	"Acceptance Criteria" (Implied by equivalence)	Reported Device Performance
   Physical/Mechanical Properties	Equivalent to current lathed DuraSoft 3 UV lenses.	Measured properties show that the lathed lenses are equivalent to predicate lenses.
   Cytotoxicity	Meet USP requirements (no cell lysis/toxicity).	No evidence of causing cell lysis or toxicity. Test article met USP requirements.
   Systemic Injection	Meet USP requirements (no mortality/systemic toxicity).	No mortality or evidence of systemic toxicity from extracts. Each test article extract met USP requirements.
   Ocular Irritation	Not irritant to ocular tissue (rabbit model).	SC (sodium chloride) and CSO (cottonseed oil) test article extracts would not be considered irritants.
   Residual Analysis	No dye extractables detected.	No dye extractables detected.
   Lens Compatibility (Care Regimen)	Parameters within manufacturing tolerances; tint color evident after 30 cycles.	Any changes in parameters through 30 cycles were within manufacturing tolerances. Tint color still evident.
   Light Transmittance	No significant difference before and after cycling.	All variances within experimental tolerance. No significant difference before and after cycling.
   Microbiology	Sterilization identical to predicate device (DuraSoft 3 UV).	Manufacturing, packaging, and sterilization are identical to predicate device.
   Overall Conclusion	Substantially equivalent to DuraSoft® 3UV lenses and CustomEyes (bufilcon A) tinting.	ProSoft lenses are substantially equivalent to DuraSoft® 3UV lenses (K965052) and CustomEyes tinting (P850057).

2. Sample sizes used for the test set and the data provenance:
   The document does not explicitly state numerical sample sizes for each test listed (e.g., cytotoxicity, systemic injection). It mentions "samples of lenses were extracted" for residual analysis. The data provenance is internal to Wesley Jessen Corporation's testing for regulatory submission to the FDA (USA). The studies are preclinical and aim for substantial equivalence rather than clinical efficacy trials with patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The "ground truth" here is based on laboratory-derived measurements and established safety standards (e.g., USP requirements) and comparisons to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:
   Not applicable. The tests are laboratory measurements against established criteria, not expert adjudication of a test set.

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:
   Not applicable, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is not an AI device.

7. The type of ground truth used:
   The ground truth for performance claims is based on laboratory measurements and established safety/material standards (e.g., USP standards for cytotoxicity, systemic injection, ocular irritation) and comparison to the physical/mechanical and safety profiles of legally marketed predicate devices.

8. The sample size for the training set:
   Not applicable, as this is not an AI device. There is no concept of a "training set" in the context of this device's development as described.

9. How the ground truth for the training set was established:
   Not applicable, as this is not an AI device.

Ask a specific question about this device

Ask a specific question about this device

Spherical: DuraSoft® 3 Spherical (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. The lens range in power from -20.00 to +20.00 diopters for daily wear.

OptiFit Toric: DuraSoft® 3 OptiFit Toric (phemfilcon A) Clear, Colored, Complements ColorBlends and Handling Tint Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. The lens range in power from -20.00 to +20.00 diopters for daily wear.

Prosthetic: DuraSoft® 3 Prosthetic (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for Daily Wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.

The lenses are indicated for Daily Wear in not-aphakic and/or aphakic persons. The eve care practitioner may prescribe the lens for daily use with routine cleaning, ninsing and disinfection. The lens may be disinfected using a chemical (not heat) disinfection system only.

DuraSoft 3 Contact Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the comea and into the eye.

The dimensions of DuraSoft® 3 and DuraSoft® 3 UV (phemfilcon A) Spherical and OptiFit Toric hydrophilic contact lenses in Clear, Colors, Complements, ColorBlends and Handling Tint are the same as approved in PMA 830037/S41 and K982344.

The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate. The DuraSoft® 3 UV (phemfilcon A) contact lenses are made by adding the UV absorber to the monomer mixture. The physical properties of the lenses are listed below. The light transmittance table has been added as approved for the Supplement No. 42 PMA P830037 and 510(k) K991550 (FreshLook Bifocal UV-absorbing (phemfilcon A) contact lenses). The data to support this table is available in Section X, Exhibit -3.

Physical properties of the lenses:
Specific Gravity: 1.178
Refractive Index: 1.411
Light Transmittance:
Handling Tint: 95% minimum
Color: 95% minimum
Surface Characteristics: Lathed and polished
Water Content: 55%
Optical Zone:
Handling Tint: 5 mm to 9 mm (varies with power)
Colors: 5 mm
Oxygen Transmissibility (Dk/L): 32.2 x 10 to the power of -9 ml O2 cm at 35° C sec ml mm Hg

Light Transmittance
a) Visible (600 nm)≥95%
b) UV (250-400 nm) †
DuraSoft® 3UV with Handling Tint
UVA (315-380 nm) +2.00 0.6, -4.00 4.0, -3.00* 2.3
UVB (280-315 nm) +2.00 3.1, -4.00 10.7, -3.00* 7.3
DuraSoft® 3UV with Carbazole violet in-monomer tint
UVA (315-380 nm) +2.00 0.7, -4.00 2.7, -3.00* 2.9
UVB (280-315 nm) +2.00 1.7, -4.00 5.2, -3.00* 5.6

† The referenced data was determined from "Methods for Determining Ultraviolet Transmission of UV-blocking Contact Lenses," by Dr. H. Faubl, International Contact Lens Clinic, Vol. 25, no.5, 1998.
Representative of the thinnest lens design.

The provided text is a 510(k) Pre-market Notification for contact lenses. It serves to establish substantial equivalence to a predicate device and does not contain information on device performance studies or acceptance criteria in the manner typically found for AI/ML-based diagnostic devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This document is a regulatory submission for a medical device (contact lenses), not a report on a clinical study or performance evaluation with statistical metrics for an AI/ML system.

Ask a specific question about this device

The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the comea and into the eye.

The GentleTouch UV (netrafilcon A) soft (hydrophilic) contact lenses are available as handling tinted hemispherical lenses with base curves of 8,2 mm and 8,5 mm and a diameter of 14.5 mm. The lens may be worn by persons that require a spherical lens in the power range from -20,00 to +20,00 Diopters (D) for daily wear. The lens material, netrafilcon A, is a hydrophilic copolymer of N.N-dimethyl acrylamide, methyl methacrylate, with a UV absorbing monomer (UVAM) and Inmonomer tint. It consists of 65% water and 35% netrafileon A. The lenses are manufactured by injecting a small amount of netrafilcon A monomer into a polypropylene mold and then thermally cured.

The provided document describes the safety and effectiveness of the GentleTouch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, submitted as a 510(k) premarket notification (K991000). The core of the submission is to demonstrate substantial equivalence to previously marketed devices.

Here's an analysis of the acceptance criteria and the study as presented:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for all listed properties. Instead, it presents physical and mechanical properties of the GentleTouch UV lens and often compares them to existing lenses or established standards (like USP requirements). The primary acceptance criterion for the submission appears to be demonstrating substantial equivalence to a predicate device (GentleTouch lenses approved under PMA P890012) and similarity to other UV-blocking and tinted lenses (Precision UV, K961299 etc.).

Given this, the table below reflects what can be inferred as performance benchmarks or direct measurements.

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., how many lenses were tested for refractive index, number of animals for toxicology, or how many lenses were cycled for compatibility). The phrasing "Samples of lenses were extracted" and "The ultraviolet spectra of cycled lenses was individually measured" indicates a sample was used, but the quantity is not provided.
• Data Provenance: The data is presented as a summary of preclinical studies and tests conducted by the applicant, Wesley Jessen Corporation. The country of origin is implicitly the USA, where the company is located and the application was filed. The studies are retrospective in the sense that the data has already been collected and presented as part of the submission.

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

This section is not applicable (N/A). The document describes device testing for physical, chemical, and biological properties, not a study involving human interpretation where "ground truth" would be established by experts (e.g., image reading). The "ground truth" here is the established scientific and regulatory standards for biocompatibility, material properties, and performance.

4. Adjudication Method for the Test Set:

N/A. As this is not a study involving human assessment or interpretation for a diagnostic or screening device, there is no adjudication method in the traditional sense. The tests are laboratory-based measurements and observations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret cases with and without AI assistance. The submitted information focuses on the physical, chemical, and biological characteristics of a contact lens.

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

N/A. This is not an algorithm or AI-based device. The "performance" described is the inherent properties of the contact lens material and design.

7. The Type of Ground Truth Used:

The "ground truth" for the various tests relies on established scientific methodologies and regulatory standards:

• Physical Properties: Measured values against material specifications and industry standards.
• Mechanical Properties: Comparison against an existing, approved device (lathed GentleTouch lenses), implying the accepted performance of the predicate device is the "ground truth."
• Toxicology: Compliance with USP (United States Pharmacopeia) requirements for cytotoxicity, systemic injection, and ocular irritation.
• Residual Analysis: Absence of detectable extractables, as determined by High Performance Liquid Chromatography (HPLC) and spectrophotometric methods.
• Lens Compatibility: Maintenance of parameters within manufacturing tolerances and no adverse effects compared to uncycled control lenses, using recognized disinfection systems.
• Light Transmittance: Comparison of pre- and post-cycled measurements, with "no significant difference" being the benchmark.

8. The Sample Size for the Training Set:

N/A. The concept of a "training set" applies to machine learning algorithms, which is not relevant to this contact lens submission. The material properties were developed and optimized, but this is a manufacturing and materials science process, not an AI training process.

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

N/A. As there is no training set in the AI sense, this question is not applicable. The development of the lens material and manufacturing process would have involved iterative testing and refinement against desired specifications and performance targets, but this is distinct from establishing "ground truth" for an AI training set.

Ask a specific question about this device

FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.

The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively. The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.

The provided text is a 510(k) Summary for the FreshLook® Bifocal UV-absorbing Contact Lenses. It details the device's characteristics and its equivalence to a predicate device but does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document states, "Reference PMA Supplement P830037/S042 Exhibit IV-1, Exhibit IV-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table of the FreshLook Bifocal UV-absorbing Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lonses submitted to the agency for Real Time Review," and refers to this PMA Supplement for "technological device characteriatios" and "manufacturing." This suggests that the detailed study data regarding acceptance criteria and performance might be located in the referenced PMA Supplement, which is not part of the provided text.

Therefore, for the FreshLook® Bifocal UV-absorbing Contact Lenses, based only on the provided text:

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

This information is not available in the provided document. The document lists physical properties but not against specific acceptance criteria in a performance study context.

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

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not available in the provided document. As this is a physical contact lens, expert adjudication in the manner of diagnostic AI is not directly applicable. However, clinical trial data would involve ophthalmologists or optometrists, but details are not provided.

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

This information is not available in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is a contact lens and not an AI-powered diagnostic tool involving human readers.

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

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

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

This information is not available in the provided document. For contact lenses, "ground truth" would typically refer to established clinical endpoints and measurements (e.g., visual acuity, comfort, fit, physiological response of the eye), but no details of such studies are included here.

8. The sample size for the training set:

This information is not applicable as the device is a physical contact lens, not an AI model requiring a training set.

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

This information is not applicable as the device is a physical contact lens, not an AI model.

Summary of available information from the document:

The 510(k) summary focuses on the device's description, its intended use, and its substantial equivalence to a predicate device (FreshLook® UV). It details the physical properties and range of parameters for the contact lenses. The approval letter confirms that the device is "substantially equivalent" to legally marketed devices, allowing it to proceed to market. The basis for this equivalence and any specific performance studies with acceptance criteria appear to be contained in the referenced PMA Supplement P830037/S042, which is not provided in this text.

Ask a specific question about this device

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may have 2.00 diopters(D) or less of comeal astigmatism that does not interfere with visual acuity. The contact lenses may be prescribed for daily wear. The eye care practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfecting and scheduled replacement. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical, heat or hydrogen peroxide disinfecting system. Precision UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.

Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are available as clear and locator tinted spherical lenses in the power range from -16.00 to + 10.00 diopters, center thickness from 0.09 - 0.17 mm (minus lenses) and 0.22 - 0.41 mm (plus lenses) with base curves of 8.4 and 8.7mm and a diameter of 14.4mm. The lens material. vasurfilcon A. is a hydrophilic random copolymer of N-vinyl-pyrrolidone (NVP), Methl methacrylate (MMA), Allyl methacrylate (AMA), Ultraviolet absorbing monomer (UVAM) and AIBN (Azo-Iso-butyronitrile) as an initiator. It consists of 74% water and 26% vasurfilicon A.

This document discusses the K982988 submission for the Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses. The submission is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence, rather than providing extensive de novo clinical trial data.

Therefore, the typical structure for a detailed acceptance criteria breakdown, including specific performance metrics, sample sizes, expert qualifications, and ground truth methodologies associated with new clinical studies for device performance, does not directly apply in the same manner as it would for a PMA (Premarket Approval) or de novo submission requiring extensive new clinical efficacy and safety data.

Instead, the core of this submission revolves around demonstrating that the "Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses are identical to previously marketed Precision UV™ (vasurfilcon A) Hydrophilic Contact Lenses of the same material" (as stated in Section D). The key point of the K982988 submission is the modification of labeling and indications for use, not a fundamental change in the device itself or its core performance characteristics.

Here's an analysis based on the provided text, addressing your questions where possible within the context of a 510(k) for labeling changes:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for labeling modifications of an already marketed and substantially equivalent device, the acceptance criteria are not explicitly defined in terms of new performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and justifying the updated labeling.

However, the previous approvals (PMA P940013 and 510(k) K961299) would have established performance criteria for the device's physical, optical, chemical, biocompatible, and microbiological properties, as well as clinical safety and effectiveness for its original indications. The current submission relies on these prior approvals.

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

The document explicitly states: "There were no changes to the lens material or design; however, the associated labeling and indications were changed." This implies that no new clinical test set was used to prove the device's fundamental performance for this specific 510(k) submission. Instead, the submission relies on the existing data and approvals for the predicate device.

The basis for the new labeling claims (specifically UV protection) is described as "referenced literature (epidemiological studies, non-clinical research reports, studies on the nature of UV energy, etc.) submitted under 510(k) premarket notification, K982988, and PMA Supplement, P940013/S6". This indicates that the support for the UV claim comes from existing scientific literature and non-clinical data, rather than a new primary clinical trial. Therefore, specific sample sizes and provenance for a "test set" demonstrating the device's primary clinical performance for this submission are not provided because the device itself hasn't changed.

For the original PMA P940013 and 510(k) K961299, clinical trials would have been conducted with specific sample sizes, and the provenance would likely be multi-center clinical studies, typically prospective. However, these details are not provided in this excerpt.

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

Not applicable for this 510(k) submission as no new clinical test set requiring expert adjudication for ground truth was conducted for the device's core performance. The "experts" involved are likely the regulatory reviewers at the FDA and potentially the internal scientific/medical team at Wesley Jessen, who evaluated the referenced literature for the UV claims.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set requiring adjudication was conducted for this 510(k).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and an AI system is evaluated for its assistance. A contact lens is a therapeutic/corrective device, not an interpretative one in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. There is no "algorithm" or AI component to this contact lens.

7. Type of Ground Truth Used:

For the original device approvals (PMA P940013 and 510(k) K961299), the ground truth for clinical safety and effectiveness would have been based on:

• Clinical outcomes data: Measured visual acuity, comfort, adverse event rates, biomicroscopic findings, etc., observed in human subjects.
• Physical/Chemical/Optical standards: Compliance with established laboratory tests for lens properties.

For the new UV claim in this 510(k) K982988, the "ground truth" for the claim's validity is derived from:

• Referenced literature: Epidemiological studies, non-clinical research reports, studies on the nature of UV energy. This implies a scientific consensus on the effects of UV radiation and the ability of certain materials to block it, rather than new primary data from this specific device.

8. Sample Size for the Training Set:

Not applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical product, not an AI.

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

Not applicable.

Ask a specific question about this device

The DuraSoft® 3 UV Optifit Toric (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of vision acuity in aphakic and for not-aphakic person with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The DuraSoft® 3 UV Spherical (phemfilcon A) Clear, Colored, Complements and Handling Tint Soft (Hydrophilic) contact lenses are indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopter (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters for daily wear.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. Additional information is available in the Wearing Schedule Section of the package insert, patient instruction and fitting quide. The lenses may be disinfected using a chemical disinfection system.

The DuraSoft® 3 UV (pherical and Optifit Toric hydrophilic contact lenses in Clear, Colors, Complements and Handling Tint are hemispherical shells of the lens material (phemfilcon A). A hydrophilic copolymer of 2-hydroxyethy) methacrylate and 2-ethoxyethyl methacrylate.

The DuraSoft® 3 UV Optifit Toric Contact lenses and DuraSoft® 3 UV (phemfilcon A) Spherical Contact Lenses are made by adding the UV absorber and carbazole violet in-monomer tint to the monomer mixture. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configuration.

The provided document is a 510(k) summary for contact lenses and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the way typically expected for medical devices involving algorithmic performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

However, based on the content available, here's a breakdown interpreting the request in the context of this document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with quantitative targets for performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" are implied to be that the new device's physical, optical, and chemical properties, as well as final lens specifications, are identical or equivalent to those of the previously approved predicate device.

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

The document refers to "pre-clinical toxicology and compatibility studies." It does not specify the sample size for these studies, nor does it provide information about data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The studies were pre-clinical toxicology and compatibility studies, which typically involve laboratory testing and not human expert-driven ground truth establishment in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the "test set" in this context refers to pre-clinical testing, not human-read diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/not provided. The device is a contact lens, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided. The device is a contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the pre-clinical studies would be established through scientific measurement and analysis of the physical, optical, and chemical properties of the contact lens material and the finished lenses, compared to established benchmarks or the predicate device. This is a scientific and laboratory-based ground truth, not expert consensus or pathology in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of contact lens material and design testing.

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

This information is not applicable/not provided as there is no training set for this device.

Study Proving the Device Meets the Acceptance Criteria:

The document states: "A thorough series of pre-clinical toxicology and compatibility studies demonstrates that all physical, optical and chemical properties for the handling tint are identical to the original opaque tint process and the final lens specifications are equivalent to the lenses approved for the opaque tinting process."

This statement is the summary of the study proving substantial equivalence. The details of these "pre-clinical toxicology and compatibility studies" (e.g., specific tests, methodologies, results, sample sizes) are not included in this 510(k) summary, but are referred to as the evidence for meeting the implicit acceptance criteria of identity/equivalence. The outcome is that the FDA determined the device to be "substantially equivalent" to predicate devices.

Ask a specific question about this device

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.

The DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses as indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.

The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.

The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:

DuraSoft 3 UV Optifit Toric
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.07 to 0.56 mm (varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters

DuraSoft 3 UV Spherical Lenses
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.05 to 0.56 mm (varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters

The lens material (phemfilcon A) is a hydrophilic copolymer of 2hydroxyethyl methylcrylate and 2-ethoxyethyl methacrylate. The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by adding the UV absorber to the polymerized rods. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configurations.

This document is a Summary of Safety and Effectiveness for contact lenses, specifically the DuraSoft 3 UV (phemfilcon A) hydrophilic contact lenses. It is a regulatory filing, not a study report describing an AI device or its performance criteria.

Therefore, items 1-9 of your request cannot be fulfilled by this document because they are specifically about the acceptance criteria and study proving performance for an AI device, which is not the subject of this text.

This document describes:

• The device: DuraSoft 3 UV contact lenses (spherical and toric).
• Indications for Use: Daily wear for correction of vision in aphakic/non-aphakic persons with non-diseased eyes (myopic/hyperopic), and for astigmatism (for the toric lens).
• Substantial Equivalence: The primary focus of this submission is to demonstrate substantial equivalence for the addition of a UV absorber to existing DuraSoft 3 lenses. The modification involves a change in the manufacturing process (adding the UV absorber to polymerized rods instead of an in-molding process).
• Device Description: Physical dimensions and material composition of the lenses.
• Physical Properties: Specific gravity, refractive index, light transmittance, surface characteristics, water content, optical zone, and oxygen transmissibility.

It is important to reiterate that this document does not discuss an AI device, acceptance criteria related to AI performance, or any studies proving such performance.

Ask a specific question about this device

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves that are revopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity.

The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eve care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.

The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:

Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.08 to 0.56 mm (Varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters

The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethy) methylcrylate and 2ethoxyethyl methacrylate. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by modifying the clear lens by affixing a colored pigment on that portion of the front surface of the lens which corresponds to the iris. The colored pigments consist of the following color additives listed in the Color Additive Provisions of the Code of Federal Requilations 21 CFR Section 706. All colored lenses contain iron oxides, titanium dioxide and [phthalocyaninato (2-1)] copper. In addition, the green lens contains chromium oxide and the violet lens contains carbazole violet. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are available in the following opaque colors: Blue, Green, Hazel and Violet. The DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses is tinted green with the color additive, phthalocyanine green for easy visibility for handling.

The physical properties of the lenses are:

Specific Gravity: 1.176
Refractive Index: 1.440
Light Transmittance:
FreshLook LiteTint: 95% minimum
FreshLook Colors: 97% minimum
Surface Characteristics: Hydrophilic
Water Content: 38%
Optical Zone (FreshLook Colors): 5 mm
(FreshLook LiteTint): 5 mm to 9 mm (Varies with power)
Oxygen Transmissibility: Dk/L = 12.9 x 10-9 ml O2 cm@ 35°C sec ml mm Hg

The provided text describes a medical device (contact lenses) and its properties but does not contain any information about acceptance criteria or a study designed to prove the device meets such criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.

The document is a "Summary of Safety & Effectiveness" for a contact lens submission (K962957), which is a regulatory document for medical devices. It focuses on:

• General Information: Device generic and trade names, manufacturer, contact person, common name.
• Indications for Use: What the contact lenses are for (correcting visual acuity for aphakic/non-aphakic persons with nearsightedness/farsightedness and minor astigmatism).
• Substantial Equivalence: How this device is similar to previously marketed devices, citing physical, optical, and chemical characteristics, and preclinical testing (cytotoxicity, systemic toxicity, ocular irritation).
• Device Description: Physical dimensions, material composition (phemfilcon A), color pigments, and physical properties (specific gravity, refractive index, light transmittance, water content, optical zone, oxygen transmissibility).
• General Use Instructions: Wearing schedules (disposable daily wear or frequent replacement wear).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML algorithm, as this document does not discuss such a device or study.

Ask a specific question about this device

Ask a specific question about this device