Search Results

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% (

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.

Ask a specific question about this device