(119 days)
The iSight, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The iSight, toric (efrofilcon A) Silicone Hydrogel Soft 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 12 diopters.
The iSight, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, irregular cornea (efrofilcon A) Silicone Hvdrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) 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/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The iSight Silicone Hydrogel Soft Contact Lenses 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 D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% 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 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided document describes a contact lens (iSight, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)) seeking 510(k) clearance, asserting substantial equivalence to existing predicate devices. The information focuses on non-clinical testing and leveraging prior clinical data from an equivalent device rather than conducting a new clinical study.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests (Implicit) | Reported Device Performance |
|---|---|---|
| Material Properties | Refractive Index | 1.38 |
| Light Transmission | > 97% | |
| Surface Character | Hydrophilic | |
| Water Content | 74 % | |
| Specific Gravity | 1.048 (hydrated) | |
| Oxygen Permeability | 59.8 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method). Note: Page 5 table lists 60 x 10⁻¹¹ | |
| Physical Dimensions | Chord Diameter | 12.0 mm to 16.00 mm |
| Center Thickness | 0.01 mm to 0.50 mm | |
| Base Curve | 8.0 mm to 9.5 mm | |
| Power Range | -20.00D to +20.00D in 0.25 step | |
| Cylinder Power (Toric) | -0.25D to -12.00D | |
| Cylinder Power (Multifocal Toric) | -0.25D to -4.00D | |
| Add Power (Multifocal) | +0.50D to +4.00D | |
| Biocompatibility/Safety | Sterility | Lenses supplied in glass vials are sterile for the indicated shelf-life. |
| Non-toxicity/Non-irritation | Packaging material and extracts are not toxic and not irritating. | |
| Equivalence to Predicate | Identical manufacturing process | Identical manufacturing process (lathe-cut versus lathe-cut) as predicate K100221. |
| Clinical performance | Previously established (not required for this 510(k)). | |
| Material characteristics | "identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" in the context of an AI/ML clinical study. Instead, it relies on a combination of non-clinical (in vitro and in vivo toxicology/biocompatibility) testing and a claim of substantial equivalence to a previously cleared device.
- Non-clinical testing: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed." No specific sample sizes for these tests are mentioned.
- Clinical data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that new clinical data specific to this device was not generated or tested. Data provenance for prior clinical studies is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a test set requiring expert ground truthing in the context of an AI/ML device. The "ground truth" for the non-clinical tests would be established by laboratory standards and validated methods for physical properties and toxicity.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set with human assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a contact lens, not an AI/ML diagnostic or assistive device for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a contact lens, not an algorithm, so standalone performance is not relevant in the AI/ML sense. The "standalone" performance here relates to the physical and chemical properties of the lens itself, which were evaluated through non-clinical testing.
7. The Type of Ground Truth Used
- Non-clinical testing: The ground truth for physical properties (e.g., refractive index, water content, oxygen permeability) would be established through standardized laboratory measurement protocols. For biocompatibility and toxicology, the ground truth would be established against accepted safety standards and protocols (e.g., GLP regulations, ISO standards for medical devices).
- Clinical data: For the previously established clinical performance of the material, the ground truth would have been patient outcomes data from those prior studies, observed by clinical investigators.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (contact lens) and its non-clinical evaluation, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device, so there is no training set or associated ground truth establishment.
§ 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.