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DAILIES® (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not 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 daily wear soft contact lens intended for single use daily disposable wear. The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution.

Here's a breakdown of the acceptance criteria and study information for the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens, based on the provided document:

This document is a 510(k) Summary of Safety and Effectiveness for a "parametric release" of the Focus® DAILIES® (nelfilcon A) ONE-DAY Soft Contact Lens. It's crucial to understand that a parametric release means the device itself is not new, but rather a change in the sterilization release criteria is being submitted. Therefore, the "study" described focuses on validating the sterilization process, not the clinical performance of the contact lens.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical test set for device performance. Instead, it focuses on the sterilization process.

• Test Set Description: The "test set" in this context refers to the samples used to validate the sterilization process and monitor bioburden.
• Sample Size (Sterilization Validation): Not explicitly stated in terms of a number of devices. The validation is described as an "overkill approach" implying robust testing. The SAL of 10⁻³² is a result of extensive validation.
• Sample Size (Bioburden Monitoring): "Results obtained from measurement of product bioburden over a 4-month period" suggests continuous monitoring, but a specific number of samples taken during this period is not provided.
• Data Provenance: The document is from CIBA Vision Corporation, located in Duluth, GA, USA. The data would therefore be assumed to be from their manufacturing facilities. The nature of the data is prospective for both initial sterilization validation and ongoing bioburden monitoring.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. There is no human expert "ground truth" involved in evaluating the performance of the sterilization process; it's based on objective physical measurements and microbiological assays. The "ground truth" is established by adherence to microbiological sterility standards.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective assessment requiring adjudication in the context of sterilization validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a material/process change related to sterilization, not an assessment of the clinical effectiveness or diagnostic performance of the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (contact lens) and a manufacturing process (sterilization), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is:

• Sterilization Validation: Microbiological testing (e.g., spore strips, lethality calculations) demonstrating the destruction of a specified number of microorganisms, and physical monitoring of autoclave parameters (temperature, pressure, time). The target microbial reduction (12-log) and probability of survival (10⁻⁶) are established industry standards for sterility.
• Bioburden Monitoring: Direct measurement of CFU (colony-forming units) of vegetative and spore-forming bacteria from product samples. This is a direct, objective microbiological measurement.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the validation of a manufacturing process against established standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as it's not an AI/ML device. For the sterilization validation, the ground truth is established by:

• Engineering principles and scientific validation protocols for steam sterilization processes.
• Microbiological testing, often involving inoculation of representative product with a known challenge organism and subsequent culturing to demonstrate inactivation.
• Adherence to regulatory standards and guidance (e.g., from FDA, ISO) for sterile medical devices.

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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."

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.

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