(125 days)
The Chic View (polymacon) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
The ChicView soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The ChicView soft contact lenses are fabricated from polymacon, which has been adopted by the United States Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material. (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution.
ChicView lenses are available clear, tinted for visibility/handling, and tinted to enhance or alter the apparent color of the eye. Tinted or color lens designs may be distributed under unique or "private label" trade names. ChicView lenses are available in gray, green, violet, brown, blue or blackwhich are tinted with one or a combination of one or more of the following "listed" color additives:
| Name of Colorant | Listing |
|---|---|
| D&C Yellow 10 | 21 CFR § 74.3710 |
| Titanium Dioxide | 21 CFR § 73.3126 |
| Iron Oxide (Red) | 21 CFR § 73.3125 |
| D&C Green No. 6 | 21 CFR § 74.3206 |
| Reactive Blue 19 | 21 CFR § 73.3127 |
| C.I. Reactive black 5 | 21 CFR § 73.3127 |
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted or color lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by entrapment of the listed color additives in the center of the contact lens (surrounded by layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The color lens tinting pattern has a minimum Clear Pupil diameter of 6.0 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution.
The physical properties of the lens are:
| Refractive Index | 1.435 |
|---|---|
| Light Transmission (clear) | greater than 98% |
| Light Transmission (tinted/color) | greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter); |
| Opaque or 0-10% (at tinted region corresponding to iris) | |
| Surface Character | hydrophilic |
| Water Content | 38±2% |
| Specific Gravity | 1.17 (hydrated) |
| Oxygen Permeability | 11.15 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method) |
The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the spherical configuration with the following features and properties:
| Chord Diameter: | 12.00 mm to 15.50 mm |
|---|---|
| Center Thickness: | 0.07 mm to 0.13 mm |
| Base Curve: | 7.0 mm to 9.0 mm |
| Power Range | -20.00D to +20.00D in 0.25D steps |
ChicView lenses are supplied sterile in saline solution containing blister packages with a base made from polypropylene and a laminated foil seal on top. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
The provided document describes the submission for a 510(k) premarket notification for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical superiority or a specific performance metric like an AI/ML algorithm might. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of comparing the device to predicates based on established physical properties and non-clinical as well as previously established clinical performance, rather than the kind of AI/ML or diagnostic study that would typically involve acceptance criteria for metrics like sensitivity, specificity, or AUC.
However, I can extract the relevant information from the document to address the spirit of your request with respect to the contact lenses' properties and testing.
Here's an interpretation based on the provided text:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)
The "acceptance criteria" for a 510(k) submission are not expressed as specific performance thresholds for "metrics" like accuracy, sensitivity, or specificity, but rather as demonstrating that the new device is as safe and effective as a predicate device and shares similar technological characteristics. The performance is assessed against the established properties of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Property | Acceptance Criteria (Predicate "Comfort 38" / "Neo Cosmo") | Reported Device Performance ("ChicView") |
|---|---|---|
| Indications for Use | Correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia; astigmatism up to 0.75D-4.00D. Available clear or colored. | Correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia; astigmatism up to 0.75D. Available clear or colored. (Slightly narrower astigmatism range than one predicate, but still considered substantially equivalent) |
| Functionality | Acts as a refractive medium to focus light on the retina. | Same as predicate device. |
| Classification | Daily Wear, Soft (hydrophilic) Contact Lens (Class II). | Daily Wear, Soft (hydrophilic) Contact Lens (Class II). |
| Production Method | Fully-molded. | Fully-molded. |
| USAN Name | polymacon. | polymacon. |
| Water Content (%) | 38±2%. | 38±2%. |
| Oxygen Permeability | 9.89 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C) (Comfort 38); 9.77 x 10⁻¹¹ (Neo Cosmo). | 11.15 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C). (Higher than predicates, implying better oxygen flow) |
| Specific Gravity | 1.18 (hydrated) for Comfort 38. | 1.17 (hydrated). (Similar to Comfort 38) |
| Refractive Index | Not explicitly stated for predicates, but implied similar. | 1.435. |
| Light Transmission (clear) | Not explicitly stated for predicates, but implied similar. | greater than 98%. |
| Light Transmission (tinted/color) | Not explicitly stated for predicates, but implied similar. | greater than 98% (clear region); Opaque or 0-10% (tinted region). |
| Surface Character | Not explicitly stated for predicates, but implied similar. | hydrophilic. |
| Minimum Clear Pupil Diameter | Not explicitly stated for predicates, but implied similar. | 6.0 mm. |
| Sterility | Implicitly sterile for predicate devices. | Sterile for the indicated shelflife. |
| Packaging Material & Extracts Toxicity/Irritation | Implicitly non-toxic/non-irritating for predicate devices. | Not toxic and not irritating. |
| Lens Physical & Material Properties | Consistent with currently marketed lenses (predicates). | Consistent with currently marketed lenses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of an algorithm's performance. Instead, it refers to non-clinical testing (in vitro and in vivo toxicology and biocompatibility) and notes that clinical performance of the polymacon lens material has been previously established, therefore, was not required for this 510(k). This implies that the "data" for establishing substantial equivalence primarily relies on previously conducted studies on polymacon lenses and specific tests on the ChicView product for its physical/material properties and sterility. No specific patient sample size for a "test set" is provided for this type of medical device submission.
- Data Provenance: The new device manufacturer is Joowon Innovation Co., Ltd. from South Korea. The non-clinical toxicology tests were conducted in accordance with GLP (Good Laboratory Practice) regulations, and other testing according to valid scientific protocols. The document does not specify if these were retrospective or prospective studies, but implies data collected specifically for the submission. The "previously established" clinical performance likely refers to prior clinical trials or post-market data on polymacon lenses in general, not specific to this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This is not applicable to a 510(k) submission for contact lenses, which relies on objective physical measurements, chemical analysis, sterility testing, and comparison to existing, widely accepted predicate devices. There is no "ground truth" to be established by multiple human experts in the way there would be for an AI diagnostic algorithm interpreting images.
4. Adjudication Method for the Test Set
- Not applicable for this type of device submission. Ground truth for properties like water content, oxygen permeability, sterility, and material composition are determined by laboratory testing and validated methods, not by human adjudication of ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists reading images with or without AI assistance). This submission concerns contact lenses, which are therapeutic/corrective devices, not diagnostic ones that involve human interpretation of complex data with varying expert opinions. The "clinical performance" here refers to the physiological compatibility and visual correction properties of the lens material and design, not an improvement in human reading accuracy with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. There is no algorithm for diagnostic or interpretative purposes in this contact lens submission. The performance assessment is focused on the physical, chemical, and biological properties of the lens itself.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is based on:
- Laboratory Measurements: Quantifiable physical properties (e.g., water content, oxygen permeability, refractive index, dimensions), and chemical composition analysis.
- Standardized Biological/Toxicological Tests: In vitro and in vivo biocompatibility and toxicology tests.
- Sterility Testing: Validation of the sterilization process and maintenance of sterility over shelflife.
- Established Clinical Performance of the Material: Relying on the known safety and effectiveness profile of polymacon, which has been widely used in contact lenses.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
§ 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.