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The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.

The provided document is a 510(k) Pre-market Notification for a contact lens, the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens. It details the device's properties and its substantial equivalence to a predicate device. This type of regulatory submission does not typically include information about studies to prove device performance against acceptance criteria in the same way a software or AI/ML device would.

Instead, for contact lenses, "acceptance criteria" are usually based on demonstrating that the new device has equivalent or better physical, optical, and chemical properties, as well as safety (toxicology, leachable compounds), compared to a previously cleared predicate device. The "study" proving this involves direct comparison of these properties through laboratory testing, rather than clinical trials with human readers or AI performance metrics.

Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size) are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the provided text, recognizing the different nature of this device type:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to the predicate device, FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear. This is achieved by showing comparable physical, optical, and chemical properties, and acceptable safety profiles.

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The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and aqua visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism 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.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (etafilcon A ) is a hydrophilic polymer of 2hydroxyethyl methacrylate (HEMA) and methacrylic acid which is cross-linked with 1,1,1trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate. When hydrated, the lens consists of 42.0% HEMA and 58.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.

The provided document is a 510(k) summary for the FREQUENCY UV™ (etafilcon A) Hydrophilic Contact Lens for Daily Wear. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving a new device meets predefined acceptance criteria through a traditional clinical study with statistical significance targets. Instead, the "study" is a comparison to the predicate device to show it performs similarly and is thus safe and effective.

Here's an analysis of the provided information in the context of acceptance criteria and the "study" that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally that the new device's properties are either identical or "substantially equivalent" to the predicate device, and any differences do not raise new questions of safety or effectiveness. The document effectively presents a comparison of the new device's properties against the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in the way a clinical trial would. For material property comparisons, it implies laboratory testing of samples from the device production.
• Data Provenance: The data for the FREQUENCY UV™ comes from direct testing of the device itself ("Preclinical Testing" and "COMPARISON OF PHYSICAL/OPTICAL PROPERTIES" sections). The predicate device data (Acuvue) is presented as established characteristics for a previously cleared product. The data is likely from the United Kingdom (Aspect Vision Care, Ltd.'s location) for the new device, and presumably from the US for the predicate's marketing clearance. This is retrospective for the predicate and prospective for the tests performed on the FREQUENCY UV™ to demonstrate substantial equivalence.

3. Number of Experts for Ground Truth and Qualifications

• This type of submission (510(k) for contact lenses) does not typically involve expert consensus for "ground truth" in the diagnostic sense, as it focuses on material properties and performance equivalence.
• The "experts" involved would be the engineers, chemists, and statisticians who designed and conducted the physical, chemical, and biological compatibility tests, along with the regulatory review team at the FDA (Division of Ophthalmic Devices). Their qualifications are implicit in their professional roles and adherence to regulatory standards for device testing.

4. Adjudication Method

• Not applicable in the conventional sense of a clinical trial where image interpretations or clinical outcomes are adjudicated. The "adjudication" here is the FDA's review process, where their experts assess whether the presented data for the new device demonstrates substantial equivalence to the predicate, and whether any differences raise new safety or effectiveness concerns.

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

• No, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an imaging algorithm or diagnostic tool that requires human interpretation of outputs.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical device (contact lens), not an algorithm or AI.

7. Type of Ground Truth Used

• The "ground truth" for this submission are the established physical, chemical, and biological properties of the contact lens material and design, as measured by standard laboratory tests (e.g., water content, Dk, transmittance, tensile strength, cytotoxicity). For the predicate device, its 'truth' is its FDA clearance (K962804) based on similar prior testing. The overall "ground truth" is that the device is safe and effective when its properties are substantially equivalent to a legally marketed predicate.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant here.

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

• Not applicable, as there is no training set for a contact lens.

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The FREQUENCY 55™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) 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.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection svstems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA. which vield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power. which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for aiding in lens centration and comfort.

The provided text is a 510(k) summary for a contact lens. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The document is a regulatory submission, not a scientific study report.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from the provided text. The requested information is absent.

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The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted) 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 Dlopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and conter over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 8mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

This document is a 510(k) premarket notification for a contact lens, establishing substantial equivalence to a previously marketed device. It does not contain an acceptance criteria table or a study proving that the device meets specific acceptance criteria in the manner typically found in a clinical study report for an AI/medical device. The approval is based on equivalence to another contact lens already on the market.

Therefore, many of the requested elements for an AI device submission are not applicable to this document.

However, I can extract information related to the device and its intended use, and explain why other sections are not present:

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

This document does not contain explicit acceptance criteria and corresponding reported device performance in the format of a clinical study or AI performance evaluation. The "acceptance" is based on demonstrating substantial equivalence to a predicate device.

The closest equivalent to "performance" stated is that the physical, optical, and chemical properties of the FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle 4 Vue (polymacon) Soft Contact Lens for Daily Wear (clear and tinted).

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

Not applicable. This is a 510(k) for a contact lens, not a study evaluating an AI algorithm on a test set. Substantial equivalence is primarily based on manufacturing information and previous approvals of predicate devices, not on a new clinical trial with a defined test set in the context of AI.

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)

Not applicable. Ground truth establishment with experts for a test set is not relevant for this type of device submission.

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

Not applicable. This document does not describe a clinical study with adjudication for 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. This is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance would be present.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. Ground truth for an AI algorithm is not relevant here. The ground truth for the safety and effectiveness of the contact lens is implicitly tied to its equivalence to previously approved, legally marketed predicate devices which have established safety and effectiveness through their own approval processes and market experience.

8. The sample size for the training set

Not applicable. This is not an AI algorithm, so there is no training set.

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

Not applicable. As there is no training set for an AI algorithm, ground truth establishment is not relevant.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical structure of an AI device submission, here's what can be extracted regarding the device itself:

• Device Name: FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
• Common Name: contact lens
• Predicate Device: The LifeStyle 4 Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
• Basis for Substantial Equivalence: Aspect Vision Care, Ltd. received all manufacturing information (formulation, processes, QC/QA, shelf life) from the predicate device manufacturer and has the right to reference its premarket notifications (K950283 and K963001). They will also manufacture the devices at the same location as the predicate devices.
• Device Description: Soft contact lenses made of HEMA crosslinked with EGDMA, designed to fit over the corneal surface for corrective refraction.
• Indications for Use: For daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Can be prescribed for daily wear in a Frequent Replacement Program and disinfected using heat, chemical, or hydrogen peroxide disinfection systems.
• Parameters Available:
  • Powers: +20.00 to -20.00D
  • Center Thickness: 0.07 mm
  • Diameter: 14.0 mm
  • Base Curve: 8.6 mm
• Regulatory Class: II
• Product Code: 86 LPL

This document is a regulatory submission demonstrating substantial equivalence for a medical device (contact lens), not a clinical study report for an AI-powered diagnostic or therapeutic device. Therefore, the requested information pertaining to acceptance criteria and study design for AI evaluation is not present.

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The FREQUENCY 55™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) 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.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which vield the appearance of lenses which are designed to fit over the comeal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 8mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

The provided 510(k) summary (K971164) describes a contact lens and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance data. Therefore, many of the requested fields cannot be directly extracted from this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a format suitable for such a table. It primarily asserts that the physical, optical, and chemical properties of the FREQUENCY 55™ lens are equivalent to its predicate device, The LifeStyle FREQUENCY™ Progressive (methafilcon A) Soft Contact Lens for Daily Wear.

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

The document does not mention a specific "test set" in the context of a clinical performance study. The submission relies on demonstrating equivalence through manufacturing information and the inherent properties of the material and design, presumed to be identical to the predicate device. Therefore, no sample size or data provenance for a test set is provided.

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

Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No test set involving human review or adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. This is a 510(k) submission for a contact lens, which typically focuses on material safety, manufacturing equivalence, and performance characteristics rather than reader studies of diagnostic accuracy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical contact lens, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety profile of the predicate device (The LifeStyle FREQUENCY™ Progressive (methafilcon A) Hydrophilic Multifocal Contact Lens for Daily Wear). The submission aims to establish that the new device is sufficiently similar to the predicate that its safety and effectiveness can be inferred. This "ground truth" is based on the previously cleared device's regulatory approval and presumed successful market history.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. As there's no training set, there's no establishment of ground truth for it.

In summary:

This 510(k) submission is for a contact lens and follows a "substantial equivalence" pathway. Its primary focus is on demonstrating that the new device is functionally and materially the same as a legally marketed predicate device, leveraging the predicate's established safety and effectiveness. It does not contain information about clinical studies with specific acceptance criteria, test sets, or expert review panels typically found in submissions for AI-powered diagnostic devices.

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