(244 days)
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.
| Property | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | iLens@ (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens (Predicate) | BIOMEDICS UV Colors (Ocufilcon D) Soft (hydrophilic) Contact Lens (Predicate) | ACUVUE 2 COLOURS Brand (etafilcon A) Contact Lens with UV blocker (Predicate) | Acceptance Criteria (Implied) |
|---|---|---|---|---|---|
| Material (USAN name) | Ocufilcon D | Ocufilcon D | Ocufilcon D | Etafilcon A | Comparable (i.e., same or similar material, demonstrating equivalence) |
| Indication for use | correction of refractive ametropia | correction of refractive ametropia | correction of refractive ametropia | correction of refractive ametropia | Comparable (similar intended use) |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded | Cast Molded | Comparable (same manufacturing process) |
| Water Content | 55% | 55% | 55% | 58% | Comparable (within similar range) |
| Light Transmittance | >97% | >95% | >97 % | > 70% | Comparable (meets or exceeds predicates) |
| Dk ($35^\circ C$) | $23 \times 10^{-11}$ | $20 \times 10^{-11}$ | $19.6 \times 10^{-11}$ | $21.4 \times 10^{-11}$ | Comparable (within similar range, slight improvement acceptable) |
| Refractive Index | 1.41 | 1.405 | 1.41 | 1.40 | Comparable (within similar range) |
| Toxicity | Non-Toxic | Non-Toxic | Non-Toxic | Non-Toxic | Non-toxic (must match predicates) |
| Color Additives | Iron oxides (red), C.I. Pigment green 7 | Reactive blue dye #19 | Iron oxides, Titanium Dioxide, Carbazole Violet, Copper Phthalocyanine Blue, Copper Phthalocyanine Green | iron oxides, titanium dioxide, Reactive blue dye 4, Vat orange 1, Phthalocyanine Green, Phthalocyaninato(2-) | Comparable in type and safety profile. Demonstrated not to raise new safety concerns. |
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.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.