(188 days)
The CONCISE, 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 CONCISE, 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 nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The CONCISE, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (mvopia 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 CONCISE, 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 CONCISE, 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 CONCISE 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% efrofileon 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 (efrofileon 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 and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Tests: | |
| Cytotoxicity, MEM Elution Test, ISO | Non-Cytotoxic |
| Ocular Irritation Test ISO | PASS, Non irritant to ocular surface |
| Acute Systemic Toxicity Test ISO | PASS, negative |
| Diameter, base curve - dry/wet | PASS, within ANSI specification |
| Power - dry/wet | PASS, within ANSI specification |
| Optical quality/clarity | PASS, within ANSI specification |
| Process repeatability | PASS, within tolerance |
| Sterility | PASS, sterile product |
| Package integrity | PASS, sterile product |
Summary of Non-clinical Testing Results:
- Lenses supplied in glass vials are sterile for the indicated shelf-life.
- The packaging material and extracts are not toxic and not irritating.
- Lens physical and material properties are consistent with currently marketed lenses.
Study Details
-
Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "a series of in vitro and in vivo preclinical toxicology and biocompatibility tests" and "a series of verification bench studies," but specific sample sizes for these tests are not provided. The non-clinical testing was conducted in laboratories according to GLP regulations and CGMP procedures.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the non-clinical tests was established by scientific and regulatory standards (e.g., ISO, ANSI, USP) and laboratory procedures, rather than expert consensus on a test set in the way one might evaluate medical imaging.
-
Adjudication method for the test set: Not applicable. The non-clinical tests involved defined pass/fail criteria based on established standards and laboratory measurements.
-
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: No MRMC comparative effectiveness study was done. This device is a contact lens, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a contact lens, not an algorithm.
-
The type of ground truth used:
- Non-clinical tests: The ground truth was based on established scientific and regulatory standards (e.g., ISO, ANSI, USP) for materials testing, toxicology, sterility, and physical properties.
- 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 the clinical ground truth for the material itself was established through prior studies on the predicate device. The new device is considered substantially equivalent due to identical material and manufacturing process to a cleared predicate (Intelliwave3).
-
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to the development and validation of manufacturing processes and material properties, not algorithm training.
-
How the ground truth for the training set was established: Not applicable for an AI training set. For the manufacturing processes, the "ground truth" (i.e., acceptable parameters and characteristics) was established by ANSI specifications and internal tolerance standards, as validated by the verification bench studies.
§ 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.