(231 days)
The IntelliWave3, 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 non-diseased 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 IntelliWave", toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated I he correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The IntelliWave", 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 non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave", 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 eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave', irregular cornea (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 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 IntelliWave3 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 group 2, 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. 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 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 birghilic 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 however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided text describes the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens and its substantial equivalence determination by the FDA. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/medical device.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document in the format of specific, quantifiable acceptance criteria. The document states that "Clinical evaluation demonstrated similar overall performance to the predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear." This is a general statement of comparative performance rather than a list of specific acceptance metrics with target values and the device's measured performance against them.
The document does list physical properties of the lens:
| Physical Property | Reported Performance |
|---|---|
| Refractive Index | 1.38 |
| Light Transmission | greater than 97% |
| Surface Character | Hydrophilic |
| Water Content | 74 % |
| Specific Gravity | 1.048 (hydrated) |
| Oxygen Permeability | 59.8 x 10^-11 (cm^2/sec)(ml O2/ml x hPa @ 35°C), (revised Fatt method) |
| Chord Diameter Range | 12.0 mm to 16.00 mm |
| Center Thickness Range | 0.01 mm to 0.50 mm |
| Base Curve Range | 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 |
The "acceptance criteria" for these physical properties are implicitly that they fall within acceptable ranges for contact lenses and are comparable to predicate devices, but explicit criteria are not given. For clinical performance, the criterion seems to be "similar overall performance" to the predicate in key areas.
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: "The study evaluated 63 patients over a three (3) months period."
- Data Provenance: Not explicitly stated (e.g., country of origin). It also does not specify if the data was retrospective or prospective, although the description of a "bilateral, open-label, parallel group, and randomized daily wear study" strongly suggests it was prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The "ground truth" for clinical performance likely relies on standardized ophthalmic examinations and patient-reported outcomes, but the adjudication process by experts is not detailed.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided.
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 as the device described is a physical medical device (contact lens), not an AI algorithm intended to assist human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable as the device is a physical contact lens, not an AI algorithm. Its performance is inherent in its physical and clinical characteristics when worn by a human.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was established through standard scientific protocols and toxicology studies according to GLP regulations, indicating laboratory measurements and biological response assessments (e.g., sterility, toxicity, irritation).
For the clinical study, the "ground truth" on performance likely involved:
- Vision: Visual acuity measurements.
- Health: Ophthalmic examinations by eyecare practitioners (e.g., assessing corneal health, ocular surface).
- Comfort and Fit: Patient-reported outcomes and clinical assessment of lens fit by eyecare practitioners.
The comparison was to a "predicate control," meaning direct comparison of these clinical outcomes between the new lens and an existing, legally marketed lens.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
§ 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.