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The OxySoft (olifilcon C) Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The OxySoft (olifileon C) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The OxySoft (olifilcon C) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with nondiseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The OxySoft (olifilcon C) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 46% olifilcon C and 54 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.9% (< 5%) in the UVB range of 280-315nm and 14.7% (< 50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

The provided document is a 510(k) premarket notification for a soft contact lens called OxySoft (olifilcon C). It does not describe an AI medical device. Therefore, a response matching the format of an AI device's acceptance criteria and study cannot be generated. However, I can summarize the information provided regarding the clinical study conducted for the contact lens.

Here's a summary of the clinical study for the OxySoft (olifilcon C) silicone hydrogel soft contact lens:

Clinical Study for OxySoft (olifilcon C) Silicone Hydrogel Soft Contact Lens

1. Acceptance Criteria and Reported Device Performance (as inferred from the summary):

The document does not explicitly state quantitative acceptance criteria for device performance in the same way an AI device would have specific metrics (e.g., sensitivity, specificity). Instead, the study aimed to demonstrate safety and effectiveness by comparison to a predicate device, focusing on:

2. Sample Size and Data Provenance:

• Test Set Sample Size: 36 subjects were enrolled.
  • Trial group (OxySoft): 24 subjects
  • Control group (Si-Hy predicate): 12 subjects
• Data Provenance: The document states, "All of them are Asia people." This suggests the data was collected in an Asian population, likely Taiwan, given the manufacturer's location. The study was prospective.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not provided in the document. For contact lens studies, "ground truth" usually refers to clinical measurements (visual acuity, slit lamp evaluations by optometrists/ophthalmologists) rather than expert consensus on images. The clinical evaluations were likely performed by the study investigators or their staff.

4. Adjudication Method for the Test Set:

• This information is not provided in the document. Clinical trials typically have protocols for handling discrepancies in measurements or adverse events, but a specific "adjudication method" in the context of expert review for ground truth (as relevant to AI) is not applicable here.

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

• No, an MRMC study was not done. This type of study model is generally used for diagnostic devices that involve human interpretation of images, often with AI assistance. This document describes a clinical study for a physical medical device (contact lens).

6. Standalone (Algorithm Only) Performance:

• No, this is not applicable. The device is a physical contact lens, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this study was established through a combination of clinical measurements and observations by healthcare professionals. This included:
  • Visual acuities
  • Slit lamp findings (e.g., for corneal health, lens fit)
  • Subjective symptoms, problems, and complaints (patient-reported outcomes)
  • Adverse reactions

8. Sample Size for the Training Set:

• This is not applicable. The study describes a clinical trial for a physical medical device, not an AI model that requires a "training set."

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

• This is not applicable as there is no AI training set.

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The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (< 5%) in the UVB range of 280-315nm and 8.7% ( < 50%) in the UVA range of 316-380nm. All colored additives used including ultraviolet absorbing additive (benzophenone based) are listed in 21CFR 73 subpart Dand 74 sbupart D.

The provided text describes a 510(k) premarket notification for a medical device, specifically a soft contact lens. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a new clinical trial with specific acceptance criteria.

Therefore, the information requested in your prompt (acceptance criteria, study design for proving acceptance, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training set details) is not applicable in this context as this submission is for a contact lens which does not utilize AI. The FDA letter and the 510(k) summary explicitly state that clinical data is not required because the new device uses the same lens material as a previously cleared device and the same color additives as another previously cleared device.

The review primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, similar technological characteristics, and is as safe and effective as a legally marketed predicate device.
• Nonclinical Testing: Performance of physicochemical studies (e.g., according to ISO 18369) and toxicology studies to ensure the material and lens properties meet established specifications and are biocompatible.

Here's how to interpret the provided information in the context of your request, highlighting why many aspects are not present:

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

• Acceptance Criteria: Not overtly stated as distinct "acceptance criteria" in the sense of a clinical trial endpoint. Instead, the "acceptance" is suitability for substantial equivalence, based on demonstrating similar properties and performance to the predicate devices.
  • Physicochemical Properties: The reported performance is that the "physical, optical and chemical properties of the lens are within established specifications for the lenses" (Section 1.9.1).
  • Toxicology: "toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment" (Section 1.9.2).
• Device Performance: The comparison table (Section 1.8) shows various characteristics of the new device and the predicate devices. The "performance" is implicitly demonstrated by these characteristics being similar or equivalent to the predicates. For example:
  • Water Content: 47% (new device) vs. 47% (predicate K160344) and 42% (predicate K162317)
  • Oxygen Permeability (DK, 35°C): 120 (new device) vs. 120 (predicate K160344) and 10.89 (predicate K162317)
  • Light Transmittance: 94% (new device) vs. 94% (predicate K160344) and 97% (predicate K162317)

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

• Not Applicable. No human clinical test set was used given the nature of the submission. The "test sets" would be the batches of lenses manufactured for physicochemical and toxicology testing. No information on the number of lenses tested is provided.

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

• Not Applicable. No human-interpreted "ground truth" was established. The "ground truth" for the non-clinical tests is based on objective measurements and established scientific methods (e.g., ISO standards, toxicology protocols).

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

• Not Applicable. No human adjudication was involved.

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 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 not an algorithm.

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

• For the non-clinical tests (physicochemical, toxicology), the "ground truth" is derived from objective laboratory measurements and adherence to established international standards (e.g., ISO 18369) and biocompatibility testing protocols.

8. The sample size for the training set:

• Not Applicable. There is no training set for an AI/ML model for this device.

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

• Not Applicable. There is no training set for an AI/ML model for this device.

In summary, the provided document is a regulatory submission for a contact lens, not an AI/ML-powered medical device. Therefore, the detailed criteria for AI/ML model validation are not present and not relevant to this specific product's clearance. The "proof" of meeting "acceptance criteria" here is the demonstration of substantial equivalence to predicate devices through shared material, similar intended use, and satisfactory non-clinical laboratory testing.

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The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The VISCO Soft Contact Lens is a spherical lens with UV blocker. The VISCO Soft Contact Lens is available in hemispherical shell. The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (1.1%) in the UVB range of 280-315nm and less than 50% (9.4%) in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.

The provided document describes the Visco Soft Contact Lens and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it focuses on the physicochemical and mechanical properties of the contact lens.

Therefore, many of the requested details regarding AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this document.

Here's an analysis based on the information available:

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

The document does not specify formal "acceptance criteria" in the context of an AI/ML device performance study with specific metrics like sensitivity, specificity, or AUC. Instead, it presents a comparison of the physical and mechanical properties of the Visco Soft Contact Lens to a predicate device. The performance is assessed by showing that these properties are comparable.

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

The document mentions "Clinical Studies" were performed but does not provide details on sample size, data provenance, or study type (retrospective/prospective). It only states: "The clinical performance result proves that the safety and effectiveness of the VISCO soft contact lens is non-inferior to the BIOFINITY (comfilcon A) Soft Contact Lens currently marketed by Cooper Vision Inc."

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 is a contact lens, not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

Not applicable.

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-assisted diagnostic tool.

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

Not applicable.

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

For the physicochemical and mechanical properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., ISO 18369-Ophthalmic optics - Contact lenses) as mentioned in section 5.11.1. For the clinical performance, the ground truth would typically come from clinical endpoints and outcomes observed in human subjects, although details are not provided here.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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