(57 days)
DAILIES® AquaComfort Plus® (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 notaphakic 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 daily wear for the optical correction of refractive ametropia (myopia or hyperopia) 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.
DAILIES® (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.
The lens material is 69% water and 31% nelficon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.
Nelfilcon A lens designs include spherical, toric, and multifocal lenses in the following parameter ranges: Power Range: -20.00D to +20.00D, Center Thickness: varies with design and power (0.10 mm for -3.00D spherical).
Lenses have the following properties: Refractive index: 1.38, Light transmittance: ≥ 92% (@ 610 nm), Water content: 69% by weight, Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method).
Lenses are supplied sterile in sealed blister-packs containing buffered saline.
The provided document, a 510(k) Summary for Nelfilcon A Soft Contact Lenses (K123994), primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical performance thresholds for safety or effectiveness for the modified device. Instead, it relies on demonstrating that the modified device's characteristics are substantially equivalent to established predicate devices. The "performance" reported is therefore a comparative one against these predicates.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Intended Use | Same as predicate (Daily Wear, Daily Disposable) | Matches predicate |
| Material Classification | Same as predicate (FDA Group 2) | Matches predicate |
| Lens Material | Same as predicate (nelfilcon A) | Matches predicate |
| Water Content | Same as predicate (69%) | Matches predicate (69%) |
| Power Range | Same as predicate (+20.00 to -20.00D) | Matches predicate (+20.00 to -20.00D) |
| Visibility Tint | Same as predicate (With or without copper phthalocyanine) | Matches predicate |
| Manufacturing Method | Similar to predicate (Lightstream® Technology; modification: integrated print step) | "Lightstream® Technology: Full mold cast, integrated print step" (Predicate K072777 is full mold cast; Predicate K083216 is full mold cast, integrated print step) - Justifies equivalence based on print technology from one predicate. |
| Lens Designs | Same as predicate (Spherical, toric, multifocal) | Matches predicate |
| Sterilization | Same as predicate (Steam sterilization, validated autoclave) | Matches predicate |
| Packaging | Same as predicate (Blister pack) | Matches predicate |
| Package Storage Saline Solution | Similar to predicate (Phosphate-acetate buffered saline with up to 0.05% Poloxamer 108. Contains PEG and HPMC) | Matches predicate K072777; K083216 has "up to 0.02% Poloxamer 108." - Difference noted but deemed not to adversely affect safety/effectiveness. |
| Physicochemical Characteristics | Substantially equivalent to predicate lens | Demonstrated to be substantially equivalent |
| Biocompatibility | Non-toxic and non-irritating, substantially equivalent to predicate device | Demonstrated to be non-toxic and non-irritating, substantially equivalent to predicate device |
| Stability | Supports labeled expiration date | Successful stability testing reported to support labeled expiration date |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device."
Therefore:
- Sample size for test set: Not applicable (no clinical test set used for the modified device).
- Data provenance: Not applicable (no clinical data for the modified device). The documentation relies on the established safety and effectiveness of the predicate devices and non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical testing was performed for the modified device. The "ground truth" for demonstrating substantial equivalence was derived from the established safety and performance of the predicate devices and the results of non-clinical, bench-top testing.
4. Adjudication Method for the Test Set
Not applicable, as no clinical testing was performed for the modified device.
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
Not applicable. This device is a contact lens, not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a contact lens.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission stemmed from:
- Substantial Equivalence to Predicate Devices: The primary "ground truth" is the established safety and effectiveness of the legally marketed predicate devices (DAILIES® AquaComfort Plus® - K072777, and FOCUS® DAILIES® - K083216). The modified device is considered safe and effective because it is fundamentally the same as these already cleared devices, with a minor modification (integrated print step from one predicate applied to the other family) that is not deemed to adversely affect safety or effectiveness.
- Non-clinical Bench Testing: Physicochemical characteristics, biocompatibility (non-toxicity, non-irritation), and stability testing were performed to confirm that the modified device's properties were substantially equivalent to the predicate and supported the labeled expiration date.
8. The Sample Size for the Training Set
Not applicable, as this is a contact lens and not an algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is a contact lens and not an algorithm requiring a training set.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" presented is a demonstration of substantial equivalence through comparative analysis and non-clinical testing, rather than a clinical trial with acceptance criteria for a novel device.
- Rationale: The modification (applying an existing print technology from one predicate contact lens family to another closely related contact lens family) was considered minor enough that new clinical data was not required.
- Evidence:
- Comparative Table (Table 1): Detail-by-detail comparison of the modified device's characteristics against two predicate devices, showing that most parameters are identical or have differences (like the specific manufacturing step for integrated print or minor saline solution variations) that are justified as not impacting safety or effectiveness.
- Non-clinical Testing: Biocompatibility testing (in accordance with GLP regulation 21 CFR Part 58) confirmed the material was non-toxic and non-irritating. Physicochemical characteristics were verified as substantially equivalent. Stability testing supported the labeled expiration date.
The conclusion is that the DAILIES® AquaComfort Plus® family of lenses (with the integrated print step) is substantially equivalent to its predicate lenses and other similar daily wear soft contact lenses, and any existing differences "do not adversely affect the safety and effectiveness of the 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.