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510(k) Data Aggregation
(91 days)
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 to -20.00 diopters. The MAXSIGHT (polymacon) Sport-Tinted contact lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye.
Replacement schedules may vary from patient to patient, and should be decided by eye care professionals in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care professionals. The lens may be disinfected using a chemical disinfection system.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is a hemispherical flexible shell which may cover a portion of the cornea and a portion of the adjacent sclera. It consists of a polymer of Hydroxyethyl Methacrylate (HEMA) and Ethylene Glycol Dimethacrylate (EGDMA), and is 38% water by weight when immersed in a sterile saline solution. This lens is tinted in the monomer with Phthalocyanine Blue Dye 246 (1, 4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone), which conforms to 21 CFR Part 73.3106. Finished lenses are subsequently tinted to achieve different colors using color additives that conform to 21 CFR Part 73.3121.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is designed to aid visual performance in athletic settings. MAXSIGHT (polymacon) Sport-Tinted Contact lenses enhance contrast in a wide range of outdoor light conditions. This allows athletes to see created objects with greater clarity than with the naked eye.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is manufactured with the following dimensions:
Diameter: 13.5 to 15.5 mm
Center Thickness: 0.06 to 0.175mm
Base Curve: 8.4-9.0mm
Powers (Spherical): +20.00D to -20.00D
The physical / optical properties of the lens are:
Specific Gravity: 1.13
Refractive Index: 1.43
Light Transmittance: ≥30%
UV Absorption: >95%
UVA absorption: >95%
UVB absorption: >95%
Water Content: 38.6%
Oxygen Permeability (Dk): 8.4x10-11[cm³O2 (STP) x cm]/(sec x cm x cm² x mmHg)@35°C (Polargraphic Method)
Each MAXSIGHT (polymacon) Sport-Tinted Contact Lens is supplied in a plastic blister container with sterile saline solution. The lid of the container is marked with the lens power, diameter, manufacturing lot number, and expiration date.
The provided text describes a 510(k) premarket notification for the MAXSIGHT™ (polymacon) Sport-Tinted Contact Lens, which seeks substantial equivalence to a predicate device. This type of submission focuses on demonstrating safety and effectiveness through equivalence to an existing legally marketed device, rather than through a comprehensive clinical trial with specific performance acceptance criteria and a detailed study design as might be seen for a novel device.
The document does not contain explicit acceptance criteria for device performance in a clinical study or a study proving that such criteria were met. Instead, it focuses on non-clinical laboratory testing to demonstrate safety and physicochemical equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria, clinical study sample sizes, expert involvement, and ground truth are not applicable or not provided in this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated as "acceptance criteria" for a primary performance study. The document reports physicochemical properties and their equivalence to a predicate device and the untinted base lens, as well as toxicology and biocompatibility test results demonstrating safety.
| Property/Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Physicochemical Properties | Equivalent to Bausch & Lomb NaturalTint® (polymacon) Contact Lens | MAXSIGHT (polymacon) Sport-Tinted Contact Lens physicochemical properties are equivalent to the predicate device. |
| Equivalent to base lens prior to tinting | MAXSIGHT (polymacon) Sport-Tinted Contact Lens physicochemical properties are equivalent to the base lens prior to tinting. | |
| Specific Gravity | (Not explicitly stated as criterion, but a property) | 1.13 |
| Refractive Index | (Not explicitly stated as criterion, but a property) | 1.43 |
| Light Transmittance | (Not explicitly stated as criterion, but a property) | ≥30% |
| UV Absorption (UVA, UVB) | (Not explicitly stated as criterion, but a property) | >95% (for both UVA and UVB) |
| Water Content | (Not explicitly stated as criterion, but a property) | 38.6% |
| Oxygen Permeability (Dk) | (Not explicitly stated as criterion, but a property) | 8.4x10⁻¹¹ [cm³O₂(STP) x cm]/(sec x cm x cm² x mmHg)@35°C (Polargraphic Method) |
| Toxicology & Biocompatibility | No detectable monomer components, cross-linker, initiator, or diluent in extracts; dye extracts < 10 ppm; no cytotoxicity or irritation. | Extracts show no detectable quantities of monomer components, cross-linker, initiator, or diluent. Levels of dye extracts are less than 10 ppm. No toxicity or irritation demonstrated in cytotoxicity testing. |
| Material Classification | FDA Group I | Falls into FDA material classification Group I. |
| USAN Name | polymacon | USAN name is polymacon. |
| Manufacturing Process | Spin-cast/Lathe cut with in-monomer visibility tinting | Manufactured by the same visibility tinted lens manufacturing process. |
| Lens Color Tinting Process | Involves tinting a fully cured soft contact lens | Involves tinting a fully cured soft contact lens. |
| Compatibility with Disinfection Systems | Compatible with several different chemical disinfection systems | Compatible with several different chemical disinfection systems. |
2. Sample Size and Data Provenance for Test Set
Not applicable/Not provided. This submission primarily relies on laboratory testing and demonstrates substantial equivalence based on material properties and manufacturing processes, rather than a clinical human use "test set" with a specific sample size. The non-clinical laboratory tests "were performed to demonstrate the safety and effectiveness" but the details of sample size for these specific tests (e.g., number of lenses tested for Dk, number of samples for extractables, or animals for in vivo tests) are not provided in this summary.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable/Not provided. No explicit "ground truth" was established by experts for a clinical test set as part of this 510(k) submission. The safety and effectiveness are established through non-clinical laboratory tests and comparison to a predicate device.
4. Adjudication Method for Test Set
Not applicable/Not provided. No adjudication method is mentioned as there was no clinical test set requiring expert interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. The submission is for a medical device (contact lens) and focuses on safety and physicochemical equivalence, not on an algorithm's impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
For the non-clinical laboratory tests, the "ground truth" is based on standardized test methodologies and accepted scientific principles for assessing physicochemical properties, toxicology, and biocompatibility, as outlined in FDA guidance (e.g., "Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994"). The ultimate "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device.
8. Sample Size for Training Set
Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set. The manufacturing process of a contact lens does not involve a "training set" in the context of machine learning.
9. How Ground Truth for Training Set was Established
Not applicable/Not provided. As there is no training set mentioned in the context of an algorithm or AI, there is no ground truth establishment for such a set.
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