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The iLens® (ocufileon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be wom by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. As prescribed for single use daily dispossble wear, patients are instructed to dispose of the lens at each removal. The iLens® Daily Wear Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is a . spherical lens with UV blocker. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is . available in hemispherical shell. The lenses are made of HEMA hydrogel. The composition is 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) 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% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary for K141280:

Acceptance Criteria and Device Performance

The provided document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a typical format of a clinical trial. Instead, it relies on demonstrating substantial equivalence to a predicate device (Biomedics® 55, K091339) through a comparison of technological characteristics, physicochemical properties, and safety/toxicology assessments.

The "acceptance criteria" can be inferred from the characteristics of the predicate device and the general requirements for soft contact lenses. The device performance is then shown by demonstrating that the iLens® either matches or is within acceptable limits compared to the predicate and established standards (like ISO 18369).

Inferred Acceptance Criteria and Reported Device Performance:

Note: The provided text primarily establishes substantial equivalence, meaning the device is "as safe, as effective and perform as well as the predicate device" (Conclusion, Section 13). It doesn't set specific quantitative acceptance thresholds for all characteristics in a pass/fail manner but rather shows comparability.

Study Details:

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

• Test Set Sample Size: The document explicitly states that no clinical data was required for this 510(k) submission because "The technical characteristics, formulation, manufacturing, and sterilization processes of the subject device are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision" (Section 12, Clinical Studies). Therefore, there is no test set of human subjects in the traditional sense of a clinical study.
• Data Provenance: The nonclinical data (physicochemical, toxicology, mechanical strength) would have been generated from laboratory testing of the iLens® product itself. The country of origin for this testing is not specified, but the manufacturer is Taiwanese. This data is prospective with respect to the device's own testing.

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

• Since no clinical studies were performed on human subjects for this submission, there was no "ground truth" derived from expert assessment of patient outcomes or imaging data in a clinical setting. The "ground truth" here is the established safety and performance profile of the predicate device and the accepted standards for contact lens characteristics (e.g., ISO 18369).

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

• Not applicable, as no human test set or clinical study requiring adjudication was conducted.

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 device, not an AI-based diagnostic tool. No MRMC study was performed.

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

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

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

• The "ground truth" in this context is the established performance and safety profile of the legally marketed predicate device (Biomedics® 55) and international standards for contact lenses (ISO 18369). The manufacturer demonstrated that the iLens® shares fundamental technological characteristics with the predicate and meets relevant standards for physicochemical, mechanical, and safety properties, thereby inferring equivalent safety and effectiveness without needing new clinical outcomes data.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable. No training set was used.

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