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The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Leases are available with in monomer tint (Vat Blue 9) and with ultraviolet absorbing additive (benzophenone based):

• in the power range of -20.00 to +10.00 diopters for sphere,
• +0.25 to +3.00 diopters for addition
• with center thickness from 0.025mm to.40mm .
• with base curves of 8.00mm to 9.20mm ●
• with diameter of 12.00mm to 15.00mm .

The lens material is the same as the one BIOMEDICS® UV (ocufilcon D) described in submission PMA890023/S4 and S7 ,K984046.

The Biomedics® UV Multifocal (ocufilton D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes that are presbyopic, with ar without associated ametropia, allowing for the correction of up to +3.00 diopters of add, with refractive astigmatism of no more than 0.75 diopters that does not interfere with visual acuity. The multifocal lens is a aspheric center near design.

The medical device in question is the BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lens.

Here's an analysis of the acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices. The submission indicates that clinical studies were not necessary because the subject device was proven equivalent in material, physicochemical characteristics, parameters, and design to already approved devices. Therefore, the "performance" is implicitly deemed acceptable if it matches the established performance of the predicate devices.

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

The submission explicitly states: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Biomedics® UV Multifocal lenses."

Therefore, there isn't a "test set" in the traditional sense involving human subjects for direct performance evaluation for the BIOMEDICS® UV Multifocal lens itself. Instead, the "test" was a comparison to existing, already approved devices based on their established characteristics and performance.

The data provenance for the predicate devices' characteristics would be from their original approvals (PMA890023/S4 and S7, K984046 for the spherical material; K003170 for the multifocal design). These would typically involve prospective clinical trials when those devices were initially approved.

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

Since no new clinical studies were conducted for the subject device to establish a "ground truth" performance directly, this section is not applicable. The implicit "ground truth" is the established safety and efficacy of the predicate devices, which would have been determined through their respective review processes by regulatory experts.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool or imaging system.

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

Not applicable. This device is a contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination was the established safety and efficacy of the predicate devices, which would have been based on a combination of:

• Physicochemical testing (as demonstrated in Table I).
• Non-clinical studies (chemistry, manufacturing, toxicology, residuals, shelf life, microbiology, sterilization, packaging) (Section 6).
• Clinical data from the original predicate device approvals (e.g., PMA890023/S4 and S7, K003170). This would have included outcomes data from patient wear, such as visual acuity, comfort, adverse events, etc., to demonstrate the safety and effectiveness of those lenses.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or a "training set" in that context. The "training" for the manufacturing process or material development would be proprietary and part of standard quality control and R&D for the company, but not a "training set" for an algorithm.

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

Not applicable for the same reasons as #8.

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