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SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.

The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available visibility tinted and cosmetic tinted. The visibility tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone, with iron oxides (red) or C.I. Pigment green 7. The cosmetically tinted lens is available in GREEN and RED. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.

This document describes the 510(k) submission for the Smart Performer 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens, which seeks to demonstrate substantial equivalence to previously cleared predicate devices. The study conducted for this device is primarily non-clinical, focusing on chemical, physical, and biocompatibility properties, rather than a clinical study involving human patients or a comparative effectiveness study with AI.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for clinical performance. Instead, it relies on demonstrating comparable physicochemical properties and safety profiles to predicate devices to establish substantial equivalence.

The "Substantial Equivalence Comparison" table in Section {6} effectively serves as the reported device performance against the predicate devices for key material and physical properties. The acceptance criterion is implied as being "comparable" to the predicates, meaning within similar ranges or showing no significant differences that would raise new questions of safety or effectiveness.

The acceptance criteria for safety (biocompatibility) were that the device showed "non-toxic" results, and no ocular irritation, delayed type hypersensitization, or acute systemic injection, which is comparable to the established safety of the predicate devices.

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

The document does not detail specific sample sizes for "test sets" in the context of clinical trials as it primarily relies on non-clinical studies and comparison to predicate devices, rather than a de novo clinical study with a distinct test set.

• Non-Clinical Studies (Product Characterization & Biocompatibility): These studies would have involved samples of the Smart Performer 55 lenses. However, the specific number of lenses or test subjects (e.g., for biocompatibility animal models or in-vitro tests) is not provided.
• Data Provenance: The studies were conducted by Smart Performer Corp. Ltd. (Taiwan, R.O.C.) as part of their 510(k) submission. Therefore, the data originates from Taiwan. The studies were likely prospective in nature for the Smart Performer 55 device (i.e., new tests performed on the device), but the overall submission relies heavily on retrospective comparison to the established safety and effectiveness data of the predicate devices.

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

This information is not applicable to this submission as it is not a clinical study involving experts establishing ground truth for performance. The "ground truth" for proving safety and effectiveness largely relies on:

• The known and accepted safety profile of the Ocufilcon D material.
• Regulatory clearances of predicate devices (iLens and BIOMEDICS UV Colors, both Ocufilcon D; and ACUVUE 2 COLOURS, Etafilcon A).
• Results from standard non-clinical tests (biocompatibility, physicochemical properties, stability).

4. Adjudication Method for the Test Set

This is not applicable as there was no test set requiring expert adjudication in the context of clinical performance evaluation (e.g., reading medical images or diagnosing conditions). The assessment involves laboratory testing and comparison to predicate device specifications.

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

This is not applicable. The device is a contact lens, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or required.

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

This is not applicable. The device is a contact lens and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Smart Performer 55 submission is established through:

• Expert Consensus (regulatory): The general acceptance of Ocufilcon D material and its known safety profile by regulatory bodies and the scientific community.
• Performance Standards/Benchmarking: Comparison to physicochemical properties (water content, Dk, refractive index, light transmittance), and biocompatibility (cytotoxicity, irritation, hypersensitization, systemic injection) against established predicate devices that have already received FDA clearance.
• Laboratory Data: Results from in-vitro and potentially in-vivo (animal) biocompatibility tests.

There is no "pathology" or "outcomes data" specifically collected for this device during a de novo clinical trial, as the submission relies on substantial equivalence to existing successful devices.

8. The Sample Size for the Training Set

This is not applicable. This is not an AI/ML device requiring a training set.

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

This is not applicable as there is no training set for an AI/ML algorithm.

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SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00 D of astigmatism or less. The lenses are available with a visibility-handling tunt or with a decorative tint intended to enhance or alter the apparent color of the eve.

Eyecare practitioners may prescribe the contact lens for frequent wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.

The SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 38% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization.

The SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens is tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone. The lens is colored with one or more of the following "list" color additives: iron oxides (red), titanium dioxide, C.I. Pigment green 7, C.I. Reactive blue 19, D&C Yellow 10 and Phthalocyaninato(2-) copper. The lens is available in the following colors: BLACK, BLUE, GRAY, GREEN, BROWN, PINK, and VIOLET. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.

The provided text describes the 510(k) premarket notification for the "SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a standalone study with specific performance metrics.

Therefore, many of the requested categories for AI/algorithm-based device studies are not applicable to this submission, as it concerns a physical medical device (contact lenses) and relies on established standards for material and design equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in the format of specific sensitivity/specificity, accuracy, or other performance metrics usually associated with AI/algorithm devices. Instead, it relies on demonstrating comparable physicochemical properties, biocompatibility, and intended use as legally marketed predicate devices.

The table below summarizes the comparison to predicate devices, which serves as the "performance" data in this context for demonstrating substantial equivalence:

Acceptance Criteria Implied by Substantial Equivalence: The acceptance criteria for this device are implicitly tied to demonstrating that its material properties, manufacturing process, intended use, and safety profile are substantially equivalent to the identified predicate devices, as supported by physicochemical and biocompatibility testing. There are no explicit quantitative acceptance criteria for performance in the way one would see for a diagnostic algorithm.

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

This is not applicable as there is no "test set" in the context of an algorithm or AI model development. The evaluation is based on non-clinical laboratory testing of the contact lens material and design, rather than a dataset of patient information. The provenance of the test data is from internal laboratory testing of the "SMART PERFORMER" lens.

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

Not applicable. Ground truth, in the sense of expert annotation of data, is not established for this type of device submission. The "truth" is based on established testing methodologies for contact lens materials and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process for a "test set" is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic or image interpretation device, so a MRMC study is not relevant.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is derived from:

• Physicochemical Testing: Measured properties like water content, Dk, refractive index, and light transmittance, compared against the properties of predicate devices.
• Biocompatibility Testing: Results from cytotoxicity, ocular irritation, skin sensitization, and acute systemic toxicity tests, demonstrating non-toxicity and safety, as compared to predicate devices and established standards.
• Clinical History of Polymacon Lenses: The document explicitly states, "Polymacon lenses have been used widely. Their safety and effectiveness have been well documented." This historical data from the "USAN name and process" being the "same as the above mentioned predicate devices" forms a significant part of the safety and effectiveness argument.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm for this device.

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

Not applicable. No training set or associated ground truth establishment process is described.

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