(85 days)
DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in non-aphakic persons with non-diseased eyes.
DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES™ lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENS is a new daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with Nformylmethyl acrylamide).
The DAILIES™ (nelfilcon A) ONE-DAY contact lens is available in a spherical lens design of the following dimensions:
• Chord Diameter: 13.8
• Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00)
• Base Curve: 8.6 mm
• Powers: +4.00D to -8.00D (0.25D steps)
-6.50D to -8.00D (0.50D steps)
A clear lens has the following properties:
- Specific gravity: 1.06
- Refractive index: 1.38 (hydrated)
- Light transmittance: ≥ 97%
- Water content : 69% by weight in normal saline
- Oxygen permeability 26 x 10-11 {(cm² /sec)(mi O2 /ml=mmHg)} at 35°C (Fatt corrected).
Lenses are supplied sterile in foil sealed blister packs containing isotonic buffered saline solution. The packaging components have tested non-toxic when evaluated in in-vitro and in-vivo laboratory studies, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister packs are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a thirty (30) month shelf-life for the DAILIÉS™ (nelfilicon A) ONE-DAY soft contact lens in foil packaging. Shelf-life studies are ongoing to determine extension of expiration dating.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DAILIES™ (nelfilcon A) ONE-DAY Soft Contact Lens:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining specific, quantifiable acceptance criteria. It broadly states that the device performed satisfactorily and demonstrated similar overall performance in key areas. The acceptance criteria essentially appear to be "not worse than predicate devices" and "performing satisfactorily."
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Nonclinical: | |
| Non-toxic | "The lens material is not toxic" |
| Non-irritating extracts | "the extracts non irritating" |
| No residual lens starting materials | "Extracts of the lens do not show the presence of residual lens starting materials." |
| Consistent physical/material properties with marketed lenses | "Lens physical and material properties are consistent with industry marketed lenses." |
| Unaffected by peroxide disinfection systems | "The lens material remains unaffected, with respect to lens properties, by exposure to peroxide disinfection systems." |
| Similar uptake and release profiles (preservatives) to predicate device | "The amount of preservatives in the tested care regimens show similar uptake and release profiles to the predicate device." |
| Clinical: | |
| Satisfactory performance in vision | "demonstrated similar overall performance in the clinically relevant areas of vision" |
| Satisfactory performance in health | "demonstrated similar overall performance in the clinically relevant areas of... health" |
| Satisfactory performance in comfort | "demonstrated similar overall performance in the clinically relevant areas of... comfort" |
| Satisfactory performance in fit | "demonstrated similar overall performance in the clinically relevant areas of... fit" |
| Overall performance similar to concurrent controls | "evaluation of the DAILIES™ (nelfilcon A) ONE-DAY Clinical lens demonstrated similar overall performance... compared to concurrent controls" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the clinical studies. It mentions "separate studies investigating both daily wear and daily disposable wearing modalities" and "three month clinical evaluations." However, specific numbers of subjects or lenses are not provided.
- Data Provenance: The studies were described as "conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812)." This typically implies prospective clinical trials. The country of origin is not explicitly stated but is implicitly the USA given the FDA 510(k) submission context. The studies were prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For contact lenses, the "ground truth" for clinical performance is typically based on ophthalmologist or optometrist examinations and patient-reported outcomes. The document refers to "clinical evaluations" and "clinically relevant areas," implying examination by qualified professionals, but the number and specific qualifications of these experts are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study, as typically understood in the context of diagnostic AI, was not conducted. This device is a contact lens, not a diagnostic imaging device requiring multiple readers to interpret cases. The clinical studies compared the lens's performance to predicate devices and focused on general safety, effectiveness, and clinical outcomes (vision, health, comfort, fit) rather than diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to a contact lens. The "device" itself is a physical product (contact lens), not an algorithm. Therefore, no standalone algorithm performance study was performed or is relevant.
7. The Type of Ground Truth Used
For the clinical studies, the "ground truth" was established through:
- Clinical Assessments: Evaluations by clinicians (ophthalmologists/optometrists) of objective measures related to ocular health, fit, and visual acuity.
- Patient-Reported Outcomes: Subjective comfort and vision satisfaction reported by the study participants.
- Comparison to Predicate Devices: Performance was assessed relative to the established safety and effectiveness of the existing predicate lenses.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical product (contact lens), not an AI/ML algorithm that requires a "training set" of data. The manufacturing and design process for contact lenses involves extensive R&D and material science, but this isn't framed as a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.