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Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuitv.

Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear or frequent replacement wear. Eye care practitioners may prescribe the lens for daily disposable wear, or for frequent replacement wear.

For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).

Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:

• The lens designs include spherical, toric and multifocal lenses.
• UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
• Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
• The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not provided.

Understanding the Device:
The device in question is a Soft (Hydrophilic) Contact Lens (Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal) made of Senofilcon A, which is visibility tinted. It's classified as a Class II medical device.

Key Point: This document is a 510(k) premarket notification decision letter, which means the manufacturer is asserting substantial equivalence to already legally marketed predicate devices, rather than proving efficacy from scratch through entirely novel clinical trials. The focus here is on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical performance data and material comparisons. Therefore, many of the typical "AI/ML validation" questions (like number of experts, adjudication, MRMC studies, training set details) will likely not apply directly to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting various ISO standards and FDA guidance documents for contact lenses. The comparison table provides specific performance data points of the subject device against its predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a separate, clinical performance study. The data provided refers to non-clinical testing of the device itself (e.g., physical, chemical, mechanical properties, biocompatibility, sterilization validation). These tests are typically performed on representative batches of the manufactured device according to established protocols and standards, but the specific number of lenses or samples tested for each property is not detailed in this summary.
• Data Provenance: The manufacturer is St. Shine Optical Co., Ltd. from New Taipei City, Taiwan. The non-clinical testing appears to have been conducted by the manufacturer or their designated labs. The information provided does not specify if any data for this device was from other countries, though the predicate device K051095's ownership was transferred to St. Shine Optical. The studies are non-clinical (laboratory/in-vitro) as opposed to retrospective or prospective patient studies.

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

• Not applicable / Not provided. This information is typically relevant for studies involving human interpretation (e.g., AI in radiology). For a contact lens 510(k) submission, "ground truth" and expert consensus would refer to established scientific and engineering principles, and validated test methods (e.g., ISO standards) for measuring physical, chemical, and biological properties, not human interpretative tasks. The "experts" involved are the individuals performing and overseeing the technical and scientific tests (e.g., chemists, material scientists, microbiologists), and the regulatory bodies (FDA) that review the compliance with standards.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Adjudication is relevant when multiple human readers/reviewers provide subjective opinions that need to be reconciled, particularly in imaging or clinical diagnostic studies. The non-clinical testing described here relies on objective measurements and standardized test methods, where results are compared against predetermined specifications and ISO standards, not subject to human adjudication in the same way.

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 device is a contact lens, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to its regulatory pathway.

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

• Not applicable. This device does not involve an algorithm or AI. It is a physical medical device (contact lens).

7. The Type of Ground Truth Used

• The "ground truth" for this submission are the established physical, chemical, and biological performance specifications and safety profiles for contact lenses, as defined by:
  • Relevant ISO standards (e.g., ISO 11981, ISO 18369 series, ISO 17665-1, ISO 10993 series for biocompatibility).
  • FDA guidance documents (e.g., 1994 FDA Guidance Document for Daily Wear Contact Lenses, FDA Guidance for Color Additives).
  • Performance characteristics of the predicate devices (K042275 and K051095), which the subject device aims to be substantially equivalent to.
  • GLP regulations (21 CFR Part 58) for biocompatibility tests.

8. The Sample Size for the Training Set

• Not applicable / Not provided. There is no "training set" in the context of AI/machine learning for this device. The manufacturing process and quality control would involve internal development and validation data, but this is not a "training set" like in AI.

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

• Not applicable / Not provided. Since there is no "training set," this question does not apply. The "ground truth" for demonstrating safety and effectiveness relies on standard testing methodologies and comparison to known safe and effective predicate devices and regulatory standards, as described in point 7.

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