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The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the comea and into the eye.

Device Description

The GentleTouch UV (netrafilcon A) soft (hydrophilic) contact lenses are available as handling tinted hemispherical lenses with base curves of 8,2 mm and 8,5 mm and a diameter of 14.5 mm. The lens may be worn by persons that require a spherical lens in the power range from -20,00 to +20,00 Diopters (D) for daily wear. The lens material, netrafilcon A, is a hydrophilic copolymer of N.N-dimethyl acrylamide, methyl methacrylate, with a UV absorbing monomer (UVAM) and Inmonomer tint. It consists of 65% water and 35% netrafileon A. The lenses are manufactured by injecting a small amount of netrafilcon A monomer into a polypropylene mold and then thermally cured.

AI/ML Overview

The provided document describes the safety and effectiveness of the GentleTouch™ UV (netrafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, submitted as a 510(k) premarket notification (K991000). The core of the submission is to demonstrate substantial equivalence to previously marketed devices.

Here's an analysis of the acceptance criteria and the study as presented:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for all listed properties. Instead, it presents physical and mechanical properties of the GentleTouch UV lens and often compares them to existing lenses or established standards (like USP requirements). The primary acceptance criterion for the submission appears to be demonstrating substantial equivalence to a predicate device (GentleTouch lenses approved under PMA P890012) and similarity to other UV-blocking and tinted lenses (Precision UV, K961299 etc.).

Given this, the table below reflects what can be inferred as performance benchmarks or direct measurements.

Acceptance Criteria (Inferred/Compared To)	Reported Device Performance (GentleTouch UV)
Physical Properties
Refractive Index (21 °C)	1.394
Light Transmittance	95% minimum
Water Content	65%
Oxygen Permeability (Dk x 10⁻¹¹ (ccO2mm)/(cm² sec mmHg))	31
Mechanical Properties
Tensile Properties (compared to lathed GentleTouch)	Equivalent to lathed lenses
Toxicology
Cytotoxicity	No evidence of cell lysis or toxicity; met USP requirements
Systemic Injection	No mortality or systemic toxicity; met USP requirements
Ocular Irritation	Not considered irritants to ocular tissue
Residual Analysis
Detectable extractables in saline	No extractables detected
Lens Compatibility with Recommended Care (after 30 cycles)
Changes in parameters	Within manufacturing tolerances
Adverse effects on measured lens parameters	No adverse effects relative to uncycled controls
Tint color after 30 cycles	Still evident and effective
Light Transmittance (before and after cycling)
Significant difference	No significant difference

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

Sample Size: The document does not specify exact sample sizes for each test (e.g., how many lenses were tested for refractive index, number of animals for toxicology, or how many lenses were cycled for compatibility). The phrasing "Samples of lenses were extracted" and "The ultraviolet spectra of cycled lenses was individually measured" indicates a sample was used, but the quantity is not provided.
Data Provenance: The data is presented as a summary of preclinical studies and tests conducted by the applicant, Wesley Jessen Corporation. The country of origin is implicitly the USA, where the company is located and the application was filed. The studies are retrospective in the sense that the data has already been collected and presented as part of the submission.

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

This section is not applicable (N/A). The document describes device testing for physical, chemical, and biological properties, not a study involving human interpretation where "ground truth" would be established by experts (e.g., image reading). The "ground truth" here is the established scientific and regulatory standards for biocompatibility, material properties, and performance.

4. Adjudication Method for the Test Set:

N/A. As this is not a study involving human assessment or interpretation for a diagnostic or screening device, there is no adjudication method in the traditional sense. The tests are laboratory-based measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret cases with and without AI assistance. The submitted information focuses on the physical, chemical, and biological characteristics of a contact lens.

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

N/A. This is not an algorithm or AI-based device. The "performance" described is the inherent properties of the contact lens material and design.

7. The Type of Ground Truth Used:

The "ground truth" for the various tests relies on established scientific methodologies and regulatory standards:

Physical Properties: Measured values against material specifications and industry standards.
Mechanical Properties: Comparison against an existing, approved device (lathed GentleTouch lenses), implying the accepted performance of the predicate device is the "ground truth."
Toxicology: Compliance with USP (United States Pharmacopeia) requirements for cytotoxicity, systemic injection, and ocular irritation.
Residual Analysis: Absence of detectable extractables, as determined by High Performance Liquid Chromatography (HPLC) and spectrophotometric methods.
Lens Compatibility: Maintenance of parameters within manufacturing tolerances and no adverse effects compared to uncycled control lenses, using recognized disinfection systems.
Light Transmittance: Comparison of pre- and post-cycled measurements, with "no significant difference" being the benchmark.

8. The Sample Size for the Training Set:

N/A. The concept of a "training set" applies to machine learning algorithms, which is not relevant to this contact lens submission. The material properties were developed and optimized, but this is a manufacturing and materials science process, not an AI training process.

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

N/A. As there is no training set in the AI sense, this question is not applicable. The development of the lens material and manufacturing process would have involved iterative testing and refinement against desired specifications and performance targets, but this is distinct from establishing "ground truth" for an AI training set.

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