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Horizon 59 Oasis (hioxifilcon A) Spherical, Horizon 59 Oasis (hioxifilcon A) Toric, Horizon 59 Oasis (hioxifilcon A) Bi-con, Horizon 59 Oasis (hioxifilcon A) Bi-con Toric, Horizon 59 Oasis (hioxifilcon A) Progressive, Horizon 59 Oasis (hioxifilcon A) Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes.

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eve color.

The lenses may be disinfected using chemical systems only.

The soft contact lenses that are manufactured from Hioxifilcon A lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes.

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, generally of a diameter greater than 6 mm. The primary and secondary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

Adding color enhancement to the surface of the lens modifies the clear version of the Horizon 59 Oasis (hioxifilcon A) contact lens. The tinting process alters or changes the lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the irris. The color additives are used in the amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The practitioner may also choose tint intensity and custom mix colors.

The Horizon 59 Oasis (hioxifilcon A) lenses are available in shades of the following: blue, green, brown and aqua.

Combining one or more reactive colors additives with distilled water forms the color enhancement. The reactive color additives that may be used either alone or in combination are: Reactive Blue 19, Reactive Black 5, Reactive Red 11, Reactive Orange 78, Reactive Yellow 15, Reactive Red 180.

This document is a 510(k) premarket notification for a contact lens, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence of the "Horizon 59 Oasis (hioxifilcon A)" contact lens to a previously approved device. The "studies" mentioned are related to the physical, optical, and biological safety of the contact lens material and design, not the performance of an AI/ML algorithm.

Here's a breakdown of why each requested point is not applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. This device is a contact lens, not an AI/ML device with performance metrics like sensitivity, specificity, etc. The document assesses physical characteristics (light transmittance, expansion) and safety (leachability, toxicity).
2. Sample size used for the test set and the data provenance: Not applicable. No test set for an algorithm is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm. The safety and equivalence are determined through laboratory testing and comparison to a predicate device.
4. Adjudication method: Not applicable. No expert adjudication is described in the context of an AI/ML device.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a contact lens, not an algorithm.
7. The type of ground truth used: Not applicable. "Ground truth" in the AI/ML sense is not relevant here. The 'truth' for a contact lens involves meeting material specifications, biological safety standards, and functional requirements.
8. The sample size for the training set: Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for an algorithm is discussed.

Instead, the document describes the following for the contact lens:

• Acceptance Criteria/Performance Parameters (Implied):

  • Leachability: No identifiable evidence of tint pigment leaching.
  • Toxicology: No evidence of cellular or systemic toxicity, or ocular irritation (cytotoxicity, systemic toxicity, ocular irritation studies conducted).
  • Physical/Optical Characteristics: Equivalent to predicate device (K031774) in light transmittance, linear expansion, and radial expansion.
  • Microbiology: No changes to validated process in 510(k) K954524.
  • Compatibility: Spectra measurement after cleaning/disinfecting cycles remained the same as before.
  • Shelf Life: Study started and to be completed in 2005.

• Study That Proves the Device Meets the Criteria:

  • Leachability studies were conducted.
  • Cytotoxicity, systemic toxicity, and ocular irritation studies were conducted.
  • Light transmittance, linear expansion, and radial expansion studies were conducted, and data was compared to the predicate device K031774.
  • Compatibility studies were conducted (spectra measurement after cleaning/disinfecting cycles).
  • Shelf life study initiated.

The primary method to "prove" the device meets acceptance criteria in this 510(k) is by demonstrating substantial equivalence to an existing FDA-approved predicate device (Westcon's own K031774 for the clear lens, and K954524 for manufacturing process and packaging). The studies mentioned above support this claim of equivalence and safety.

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Horizon 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes.

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The lenses may be disinfected using chemical systems only.

The Horizon 38 (polymacon) (polymacon), Horizon 38 (polymacon) Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism) in aphakic or not-aphakic persons with nondiseased eyes.

The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The color-enhanced lenses can be chemically disinfected only. The clear lenses may be disinfected using a heat o chemical disinfecting system.

The soft contact lenses that are manufactured from W-55 and W-38 lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eves.

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, generally of a diameter greater than 6 mm. The primary and secondary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

Adding color enhancement to the surface of the lens modifies the clear version of the Horizon 55 (methafilcon A) Contact Lens and Horizon 38 (polymacon) contact lens. The tinting process alters or changes the lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additives are used in the amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The practitioner may also choose tint intensity and custom mix colors.

The Horizon Enhanced lenses are available in shades of the following: blue, green, brown and aqua.

Combining one or more reactive colors additives with distilled water forms the color enhancement. The reactive color additives that may be used either alone or in combination are: Reactive Blue 19, Reactive Black 5, Reactive Red 11, Reactive Orange 78, Reactive Yellow 15, Reactive Red 180.

The provided document describes a 510(k) submission for various contact lenses. It does not contain a study comparing the device's performance against acceptance criteria in the manner expected for diagnostic or AI-driven medical devices. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared contact lenses and addresses the safety and effectiveness of adding color enhancement to the existing lens designs.

Therefore, many of the questions regarding acceptance criteria, study design, expert involvement, and statistical measures cannot be answered from the provided text, as these types of studies were not presented for this submission. The submission is primarily focused on safety and technological characteristics, especially for the new color-enhanced versions, and references prior 510(k) clearances for the core lens designs.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

No explicit table of acceptance criteria and device performance is provided in the document in the context of a comparative clinical study for efficacy. The "performance" described relates to the safety and physical characteristics of the lenses.

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

• Sample Size for Test Set: Not specified. The studies mentioned (leachability, toxicology, microbiology, compatibility) are laboratory tests, not clinical performance tests with a "test set" of patient data in the typical sense.
• Data Provenance: Not specified. These are laboratory studies.
• Retrospective or Prospective: These appear to be laboratory studies conducted specifically for this submission, implying they are prospective for the aspects tested.

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. This submission doesn't involve establishing ground truth from expert assessments of images or patient outcomes for a diagnostic device. The "ground truth" for the tests performed would be the results of the laboratory assays themselves and comparisons to established safety thresholds.

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

Not applicable. There is no adjudication method described as this is not a study involving expert readers or interpretation of results that would require 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

Not applicable. This is a contact lens submission, not an AI-driven diagnostic device. No MRMC study was conducted.

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

Not applicable. This is a contact lens submission, not an AI-driven diagnostic device.

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

The "ground truth" for the studies performed would be:

• Leachability: Chemical analysis results (absence of tint pigment in leachate).
• Toxicology: In vitro (cytotoxicity) and in vivo (systemic toxicity, ocular irritation) laboratory assay results compared to control or safety thresholds.
• Microbiology/Compatibility: Laboratory measurements comparing pre- and post-processing characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The submission demonstrates the safety and effectiveness of the color-enhanced versions of the contact lenses by showing they are substantially equivalent to their clear counterparts (K992010 and K963837) and do not raise new questions of safety or effectiveness. The core lenses themselves are already FDA-approved.

The studies performed for the color-enhanced lenses, as described in the "Summary of Safety and Effectiveness 6.0" and "7.0 Technical Summaries" sections, include:

• Leachability Studies: Showed "no identifiable evidence of tint pigment leaching." This addresses a critical safety concern for color additives in contact with the eye.
• Toxicology Studies: Included cytotoxicity, systemic toxicity, and ocular irritation studies. Results showed "no evidence of cellular or systemic toxicity, or ocular irritation." This confirms the biological safety of the materials, including the color additives.
• Physical/Optical Characteristics Review: Concluded that the "color-enhanced version remains the same as the clear version." This indicates no significant alteration to the lens's fundamental optical properties or fit due to the color.
• Microbiology Review: Stated that "There will be no changes to the validated process in 510(k) K954524," implying the sterilization and manufacturing processes for the color-enhanced lenses are consistent with previously validated methods, maintaining sterility.
• Compatibility Studies: Indicated that "The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement." This demonstrates that the color-enhanced lenses hold up to standard care routines without degradation.
• Shelf-life Study: Was started and would be completed later, based on relevant guidance documents. This is an ongoing study to confirm the stability of the lenses over time.

Conclusion: The submission relies on these laboratory and characteristic studies to support the claim that adding color enhancement does not negatively impact the safety and effectiveness established for the predicate clear lenses. The FDA's final decision letter (K031774) confirms that the device is "substantially equivalent" for the stated indications based on this presented data.

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The Horizon 38 (polymacon). Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.

The lens may be disinfected using either a heat or chemical system .

The soft contact lenses that are manufactured from W-38 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of ametropia (myopia, hyperopic and astigmatism). Each lens provides corrective power, which corresponds 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, generally of a diameter greater than 6 mm. The primary and secondary, as well as, beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

This document describes the premarket notification (510(k)) for Westcon Contact Lens Company's Horizon and Westhin contact lenses. It focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a study with specific acceptance criteria and performance data in a traditional sense. Therefore, many of the requested elements for an AI/device performance study are not applicable or directly available in this document.

However, I can extract the relevant information regarding their "acceptance criteria" (or more accurately, the tests performed to demonstrate substantial equivalence) and what the document reports.

Here's an attempt to structure the available information according to your request, with significant caveats for clarity:

Acceptance Criteria and Device Performance for Westcon Horizon and Westhin Contact Lenses (Based on 510(k) K023530)

Note: This 510(k) submission is for demonstrating substantial equivalence to existing predicate devices (K963837 and K954524) for contact lens material change (from Benz's polymacon to W-38 polymacon). It is not a clinical study to prove the performance of a novel device against specific clinical endpoints or acceptance criteria in the typical modern sense. The "acceptance criteria" here are implied by the tests performed to show that the new material is equivalent and does not raise different questions of safety and effectiveness.

Information on the "Study" (Demonstration of Substantial Equivalence):

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

   • The document does not specify sample sizes for any of the studies (leachability, toxicity, physical/optical characteristics, compatibility).
   • Data Provenance: Not explicitly stated, but it would be laboratory testing conducted by or for Westcon Contact Lens Company. It is "prospective" in the sense that these tests were performed for this specific submission to characterize the W-38 polymacon material.

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

   • Not applicable/mentioned. The "ground truth" here is the outcome of standardized laboratory tests and comparisons to predicate device data, not expert consensus on medical images or clinical observations.

3. Adjudication method for the test set:

   • Not applicable. This was a series of laboratory tests, not a clinical trial with human observers and 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:

   • Not applicable. This is a 510(k) for contact lenses, not an AI-powered diagnostic device.

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

   • Not applicable. This is a 510(k) for contact lenses, not an AI algorithm.

6. The type of ground truth used:

   • The "ground truth" here refers to laboratory test results (e.g., cytotoxicity assays, spectrophotometer readings for leachability and compatibility, physical property measurements) and comparative data from the predicate device (K963837) for physical/optical characteristics.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm.

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

   • Not applicable. This is not a machine learning or AI algorithm.

Summary of the Submission's Conclusion:

Westcon Contact Lens Company concluded, and the FDA agreed, that the data submitted demonstrated that manufacturing with W-38 polymacon instead of Benz's polymacon material "does not raise different questions of safety and effectiveness." This established substantial equivalence to their previously approved devices (K963837 and K954524).

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The Horizon 55 Westint and Horizon 55 (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia.

W-55 (methafilcon A) clear or tinted lens blanks are a hydrophilic polymer of 2hydroxyethy methacrylate crossed linked with ethyleneglycol dimethacrylate. The lens consists of 45% methafilcon and 55% water by weight when immersed in buffered saline solution. When the lens blank is tinted blue, up to .8 % of the color additive Copper Phthalocyanine Blue Pigment will be added to the MA. The color additive conforms to 21 CFR Part 74.3045.

The soft contact lenses that are manufactured from W-55 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell which are designed to fit over the corneal 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 myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (multifocal). Each lens provides corrective power, which corresponds 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, generally of a diameter greater than 6 mm. The Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

This document describes a 510(k) submission for a modification to an approved device, specifically adding a visibility tint to contact lens blanks and the resulting contact lenses. It is not an AI/ML device, so it doesn't contain information typically found in studies for AI/ML devices, such as sample sizes for test/training sets, expert ground truth, or MRMC studies. The "study" here refers to the testing conducted to ensure the safety and effectiveness of the tinted lenses compared to the already approved clear lenses.

Here's an analysis based on the provided text, focusing on the established safety and effectiveness of the modified device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many tinted lenses were tested for each characteristic. It refers to "samples of tinted lenses" (e.g., in Toxicology and Physical/Optical Characteristics sections). For compatibility, it states "all lenses were within normal limits" after 30 cycles, implying a sample was used but no number is given.
• Data Provenance: The studies were conducted by Westcon Contact Lens Company, Inc. (the submitter). The country of origin is not explicitly stated but implies internal studies based in the US (Grand Junction, CO). The studies are retrospective in the sense that they are comparing the newly tinted lenses against previously established data for the clear lenses (predicate device K954524), and are prospective in that new testing was performed on the tinted lenses.

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 device is a medical device (contact lens) and not an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" here is objective physical and chemical measurements (e.g., light transmittance, toxicity tests).

4. Adjudication Method for the Test Set

• Not applicable as this is not an AI/ML device. The "adjudication" is based on laboratory test results meeting established scientific and regulatory 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

• Not applicable. This is a contact lens, not an AI/ML system that would assist human readers.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for demonstrating safety and effectiveness relies on objective scientific, chemical, and physical measurements and toxicological assessments. This includes:
  • Chemical analysis for pigment leaching.
  • Biological assays for cytotoxicity, systemic toxicity, and ocular irritation.
  • Physical measurements for light transmittance, refractive index, water content, linear expansion, radial expansion, and tensile strength.
  • Compatibility testing (e.g., durability cycles).

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. The "training" for this device would be the extensive research, development, and testing conducted on the original clear lens (K954524) to establish its safety and effectiveness.

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

• Not applicable. As above, this is a physical medical device. The "ground truth" for the original clear lens was established through:
  • "Non-clinical studies" for the clear lenses run in 1995 (referenced in 7.4 Compatibility).
  • Extensive toxicology, physical/optical characteristics, and microbiology studies conducted for the original 510(k) K954524.
  • These studies would have involved scientific methods, laboratory tests, and adherence to relevant standards and guidance documents (e.g., "Shelf Life of Medical Devices-April 1991 and Premarket Notification Guidance Document for Daily Wear Contact Lenses-May 1994" mentioned in 7.5 Shelf Life).

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