(30 days)
The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. 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 Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes and or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethy]) phenylamino]-9, 10-Anthraquinone) as an integrated handling tint. The lenses are made by lathe-cut for individual patients. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
This document is a 510(k) Pre-market Notification for a contact lens, specifically the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria.
Based on the provided text, a conventional acceptance criteria table and performance study of an AI/algorithm-driven device meeting those criteria cannot be constructed because:
- The device is a physical product (contact lens), not an AI/algorithm system.
- The document describes a "Special 510(k) Summary," which typically relies on demonstrating equivalence to legally marketed predicate devices rather than proving performance against novel clinical acceptance criteria through new clinical trials.
- The document explicitly states "Clinical testing was not necessary for this application."
However, I can extract the bench test performance data and compare it to reported values of the predicate devices, which serves as a form of "acceptance criteria" for demonstrating substantial equivalence for a physical product by showing similar physical and chemical properties.
Here's the information structured to best fit your request, interpreting "acceptance criteria" as the properties of the predicate devices that the new device aims to match or be comparable to:
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device like a contact lens, "acceptance criteria" in this context refer to physicochemical properties that demonstrate the new device is comparable to legally marketed predicate devices. The "reported device performance" refers to the measurements taken on the Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).
| Parameter | Acceptance Criteria (Predicate Device K100443) | Acceptance Criteria (Predicate Device K230824) | Reported Device Performance (Flexlens Silicone Hydrogel) |
|---|---|---|---|
| Refractive Index (wet) | 1.38 | 1.3770 | 1.3770 |
| Visible light transmission (%) @ 380-780nm | >97% | 94.4% | 94.4% |
| Specific Gravity (wet) | 1.048 | 1.049 | 1.049 |
| Water Content | 74±2% | 74±2% | 74±2% |
| Oxygen Permeability (Dk) ISO/FATT Method | 59.8 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) | 56.0 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) | 56.0 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
Note: The document states that the Flexlens Silicone Hydrogel device is "substantially equivalent" to both predicate devices. The table above shows that its properties align perfectly with one (K230824) and are very close to the other (K100443). The small differences (e.g., Dk value relative to K100443, Visible light transmission relative to K100443) were deemed non-relevant for substantial equivalence by the manufacturer.
2. Sample size used for the test set and the data provenance
- Test Set Description: Non-clinical (bench) testing was conducted.
- Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of lenses tested for Dk, water content, etc.). It refers to "Bench Testing-manufacturing verification testing" to demonstrate ability to manufacture lenses "on a repeatable basis" to established specifications, and "Performance Testing" for various physicochemical properties.
- Data Provenance: The data is from non-clinical (bench) tests performed by the manufacturer (X-CEL SPECIALTY CONTACTS) or a lens material manufacturer for testing of efrofilcon A contact lens blanks. The location is implied to be within the United States, given the FDA submission context. The data is retrospective in the sense that it represents lab measurements, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for a physical device's characteristics (like refractive index, water content, Dk) is established through standardized laboratory measurement methods (e.g., ISO standards), not by expert consensus or interpretation of images.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or for interpreting subjective data (like image readings), which was not conducted or required for this device's submission. The "adjudication" for bench tests would be the adherence to validated testing methodologies and equipment calibration.
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 question is not applicable. This is not an AI/algorithm device, and no MRMC study was performed as clinical testing was not necessary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/algorithm device.
7. The type of ground truth used
The "ground truth" for the non-clinical tests (physicochemical properties like Dk, water content, refractive index, etc.) are the measurements obtained using standardized laboratory testing methods (e.g., ISO standards for Dk, preservative uptake/release). For biocompatibility, the ground truth is established by adherence to GLP regulations and ISO 10993 standards, with results like "not cytotoxic," "no evidence of systemic toxicity," "no ocular irritation," and "did not produce skin sensitization."
8. The sample size for the training set
This question is not applicable. This is not an AI/algorithm device that requires a training set. The device manufacturing processes are based on established engineering principles and material science.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" for this physical device.
§ 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.