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The Saview 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Saview 58 UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. Saview 58 UV Toric lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses are available as a spherical lens for single vision. astigmatic (toric) lens and aspherical multifocal lens respectively. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate, initiated by Azobisisobutyronitrile. A UV absorbing compound 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl]ethyl methacrylate is incorporated into the lens polymer. The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses with visible tint are tinted blue using Pigment Blue 15 to make the lens more visible for handling.

This 510(k) summary describes a series of pre-clinical tests performed to demonstrate the safety and effectiveness of the Saview 58 UV contact lenses and to establish substantial equivalence to predicate devices. It does not contain information about a study based on human subjects or clinical data in the traditional sense of a device performance study.

Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable or cannot be extracted from this document, as they relate to clinical performance evaluation, which was not the primary method of demonstrating substantial equivalence here.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for safety and effectiveness were primarily demonstrated through physicochemical equivalency and pre-clinical safety tests. The specific "acceptance criteria" are implied by the comparison to predicate device parameters and the successful completion of safety tests.

Study Proving Device Meets Acceptance Criteria:

A series of "pre-clinical tests" were performed. These tests focused on:

• Biocompatibility and Safety: Acute Systemic Injection, Ocular Irritation, and In Vitro Cytotoxicity Tests.
• Material Characterization: Physicochemical testing to compare properties like water content, UV transmittance, Dk, refractive index, etc., to the predicate devices.
• Residue Analysis: Evaluation for the presence of residue.
• Shelf Life Testing: To ensure sterility and property stability over time.

The conclusion states that the information submitted establishes that the Saview 58 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. This comparison to legally marketed predicate devices forms the basis of the "substantial equivalence" determination, not a standalone clinical performance study on the device's ability to correct vision.

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

• Sample Size for Test Set: Not specified. The document mentions "a series of pre-clinical tests" and "physicochemical testing" but does not detail the number of lenses or test articles used for each test.
• Data Provenance: The device manufacturer is St. Shine Optical Co., Ltd. in Taiwan. The pre-clinical tests and physicochemical evaluations would have been conducted by or for them, likely in a laboratory setting. The data is thus from laboratory testing, not a human clinical study with specific country of origin or retrospective/prospective designations.

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

• Not applicable. This document describes pre-clinical and physicochemical testing, not a clinical trial requiring human expert ground truth for diagnostic accuracy, for example.

4. Adjudication Method:

• Not applicable for the type of pre-clinical and physicochemical testing described.

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, nor is an MRMC study mentioned.

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. The device's "standalone" performance is assessed via its physical and chemical properties and biocompatibility as described in the pre-clinical tests.

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

• The "ground truth" for these tests is based on established scientific methods and industry standards for material characterization, biocompatibility testing, and comparison against the known properties of the predicate devices. For example, specific analytical techniques provide data on water content, UV transmittance, Dk, etc., which are then compared to the predicate's values. Biocompatibility tests have their own endpoints (e.g., cell viability in cytotoxicity, absence of irritation in ocular irritation).

8. The sample size for the training set:

• Not applicable. There is no machine learning or AI component requiring a training set described in this document.

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

• Not applicable. No training set is involved.

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