(29 days)
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.
The Focus DAILIES and DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.
The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high molecular weight PVA (for Focus DAILIES lenses) and/or ultra-high molecular weight PVA (for Dailies AquaComfort Plus lenses) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.
Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foilblister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.
The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (DAILIES AquaComfort Plus products) and/or 0.85 ml (Focus DAILIES products) phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. For DAILIES AquaComfort Plus lenses the package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.
Instead, it is a 510(k) summary for contact lenses (Focus DAILIES and DAILIES AquaComfort Plus) which outlines a modification to an alternate foil lidding material for their primary packaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for traditional medical devices under the 510(k) pathway, not AI/ML performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details relevant to an AI/ML device from this document.
Here's why and what information is missing:
- No AI/ML Component: The device described is a soft contact lens, a physical medical device. There is no mention of any AI or machine learning component, software, or algorithm in its functionality or development.
- No Performance Metrics for AI: Consequently, there are no AI/ML-specific performance metrics like sensitivity, specificity, AUC, F1-score, etc., nor any acceptance criteria for these.
- No Study Design for AI Validation: The "Performance Data" section discusses:
- Non-clinical Testing: Stability, biocompatibility, and process validation, referencing ISO standards relevant to material safety and manufacturing for contact lenses. These are not AI/ML validation studies.
- Clinical Testing: States that clinical testing was not required for this specific modification (changing packaging material), which further confirms the absence of AI/ML validation studies.
- No Mention of Ground Truth, Training Data, Experts: Since there's no AI, there's no need for ground truth establishment, training data, or expert adjudication as would be required for an AI/ML device.
- No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.
In summary, the provided document is not about an AI/ML medical device and therefore does not contain the information you requested.
§ 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.