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510(k) Data Aggregation
(66 days)
Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who have astigmatism of 5.00D or less.
Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.
Proclear XC and Proclear 1 Day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacrylolovoxvethyl phosphorylcholine cross linked with ethylmethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510ks.
The modifications to the stability - shelf life protocol include alternate test method for package integrity and adjusted storage temperatures for the packaged products that will be tested using alternate package integrity test method.
The provided document describes CooperVision's Proclear (omafilcon A) Soft (hydrophilic) Contact Lenses and a 510(k) submission (K111966) for a modification to its shelf-life protocol. This submission does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.
Instead, the submission argues for substantial equivalence to predicate devices based on the following:
- No change in material, manufacturing methods, lens parameters, or indicated use.
- The modification is specifically to the stability-shelf life protocol, including an alternate test method for package integrity and adjusted storage temperatures.
Therefore, the sections of your request related to device performance, clinical studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text, as these concepts are not applicable to this type of submission.
Here's what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission is for a modification to a shelf-life protocol, not for initial device performance evaluation. The document explicitly states: "Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses." and "Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol."
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a test set or data provenance for device performance. It is a submission for a modification to a shelf-life protocol.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This document does not describe a test set, ground truth establishment, or human experts.
4. Adjudication method for the test set
Not applicable/Not provided. This document does not describe a test set or adjudication method.
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/Not provided. This document pertains to contact lenses and changes in shelf-life testing, not AI or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This document pertains to contact lenses, not algorithms or standalone performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. This document does not describe a study involving ground truth for device performance.
8. The sample size for the training set
Not applicable/Not provided. This document does not describe a training set for an algorithm or device performance study.
9. How the ground truth for the training set was established
Not applicable/Not provided. This document does not describe a training set or ground truth establishment.
Summary of what the document does state regarding acceptance and substantial equivalence:
The core of this 510(k) submission is to assert substantial equivalence to previously cleared predicate devices, not to prove new performance criteria. The "acceptance criteria" here are implicitly that the modified shelf-life protocol does not negatively impact the established characteristics of the contact lenses, and that the lens properties remain within previously established specifications.
The "study" demonstrating this involves:
- Stating that the physical, optical, and chemical properties remain unchanged and within established specifications. This implies that prior testing for the original predicate devices did establish these specifications.
- Stating that toxicology results from original in-vivo and in-vitro studies remain valid, verifying non-toxicity and biocompatibility.
- Introducing an alternate test method for package integrity and adjusted storage temperatures. While not detailed, the implication is that this new method is still capable of ensuring package integrity over the stated shelf-life.
Conclusion stated in the document:
"Based on no change to material, no change to manufacturing methods, no change to lens parameters and no change to indicated use, the omafilcon A soft contact lens described in this document is substantially equivalent with the predicate devices." (Section 12)
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(53 days)
Proclear Compatibles Multifocal (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
These lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eve care practitioner. The lens may be disinfected using a chemical disinfection system.
The Proclear Compatibles Multifocal (omafilcon A soft (hydrophilic) contact lens is available as hemispherical flexible shell which covers the cornea and may cover a part of the adjacent sciera. Lens material, omafilcon A is a random copolymer of hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorycholine crosslinked with ethylene glycol dimethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive, Reactive Blue No. 4.
Proclear Compatibles Multifocal contact lens is hemispherical shell of the following dimensions:
• Diameter: 14.2mm to 15.0mm
• Base curve: 8.0mm to 9.5mm
• Center Thickness: 0.15mm to 0.96mm varies with power
• Powers: -20.00 to +20.00 D
• Add powers: +0.50 to +4.00 D
The physical properties of the lens are:
- . Refractive Index: 1.38
- Light Transmittance . 62%
- Surface Character: Hydrophilic . ・
- Water Content ● ሬቶਅ the power of
- Oxygen Permeability . 27 x 10-11 (cm2/sec){ml O2/ml x mmHq) at 35° C (modified ISO method for determination of oxygen permeability)
The provided text is a 510(k) summary for a medical device (Proclear Compatibles Multifocal contact lenses). It outlines the device description, indications for use, and regulatory information, but it does not contain any information about acceptance criteria, study design, or device performance data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting detailed clinical study results and performance metrics.
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(143 days)
Proclear and Proclear Compatibles (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement.
The Proclear and Proclear Compatibles contact lenses are available as a lathe cut spherical lens, and a molded spherical lens. The lens material (omafilcon A) is a copolymer of 2-hydroxyethy)methacrylate and 2methactyloyloxyethyl phosphorylcholine crosslinked with ethylenestycol dimethacrylate. The Proclear lens with visibility tint is timed blue using Reactive Blue Dye #4 to make the lens more visible for handling.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study (K974408)
The study aimed to demonstrate the safety and effectiveness of the Proclear (omafilcon A) Soft Contact Lenses in Defined Dry Eye patients, specifically those with Evaporative Tear Deficiency or Aqueous Tear Deficiency (non-Sjogren's only). The acceptance criteria were formulated around comparing the Proclear lens with control lenses.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Definition of Success for Proclear lens in dry eye subjects) | Reported Device Performance |
|---|---|
| A. Statistically significantly difference in the On-eye hydration relative to the Control lenses in Matched Pair Analysis. | Achieved: The data indicated that the Relative Dehydration for the Proclear lenses in Dry Eyes was consistently low as compared to that reported for the population of Control lenses in Dry Eyes (p=0.0001). The Matched Pair analysis confirms that the hydration retention characteristic of the Omafilcon A material in the Proclear lens is significantly more resistant to on-eye dehydration than the control lenses. See "Relative Dehydration at 6 Weeks (%)" in Table 1 for Proclear (Mean: 2.21-2.65%) vs. Control (Mean: 4.09-6.78%). |
| B. Achievement of a statistically significant increase in wearing time over baseline and/or the Control lens. | Achieved: The omafilcon A lenses had statistically significantly longer wearing times at each interval, determined using the Wilcoxon's Test for Matched Pairs. |
| C. Improvement or no significant difference in visual acuity; slit lamp findings; symptoms, problems, and complaints; or Adverse Reactions as compared to the performance of the Control lens in the same population. | Achieved (partially and with nuance): On the FDA defined comparative parameters, the omafilcon A lenses performed in an equivalent manner to the Control lenses except for the parameters of Wearing Time (which was an improvement for Proclear) and various Symptoms, Problems and Complaints (SPCs). Adverse reactions were minimal (one severe injection with a control lens, attributed to tight lens syndrome). |
| D. A significant difference in Signs and Symptoms relative to the Control lenses. | Achieved: A review of the data confirms this premise. Of greatest interest were the differences seen on the parameters of Comfort, Moistness of the Eye, and Frequency of Dry Eye Symptoms. The results for Comfort were further supported by differences in irritation, itchiness, burning, grittiness, watering, variation in eye sensations, and noticeability. Repeated Measures Analysis, Matched Pair Analysis, and Chi Squares Test all indicated significant differences in favor of Proclear for various comfort and dryness-related symptoms. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 76 Dry Eye subjects.
- Data Provenance: The study was a "prospective, randomized, controlled, crossover study" conducted to assess the performance of the Proclear lens. While the specific country of origin is not explicitly stated, the submitter's address is in Norfolk, VA, USA, suggesting the study was likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The "ground truth" for this study appears to be derived from objective measurements (visual acuity, slit lamp findings, on-eye dehydration) and subjective patient self-evaluations (Visual Analogue Scale for symptoms, comfort, etc.) rather than expert consensus on imaging or diagnostic criteria.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the typical sense for diagnostic studies (e.g., 2+1 reader adjudication). The study design involved a crossover trial where subjects wore both Proclear and control lenses, and their responses (objective findings and subjective self-evaluations via Visual Analogue Scale) were compared. Statistical tests (paired Student's t-test, Wilcoxon's signed ranks test, Repeated Measures analysis, Chi Squares Test) were used to analyze the differences.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is testing the performance of a contact lens in human subjects directly, not the performance of AI in assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense, the "device" (Proclear lens) was evaluated in a standalone manner relative to a control lens. There is no AI algorithm being tested here; it's a medical device (contact lens) performance study. The data analyzed reflected the direct impact and performance of wearing the Proclear lens compared to control lenses on various physiological and subjective parameters.
7. The Type of Ground Truth Used
The "ground truth" in this study is a combination of:
- Objective Clinical Measurements: Visual acuity, slit lamp findings, and on-eye dehydration measurements.
- Subjective Patient-Reported Outcomes: Self-evaluation of symptoms, problems, and complaints using a Visual Analogue Scale (VAS) for parameters like comfort, moistness, frequency of dryness, irritation, itchiness, etc.
- Behavioral Data: Lens wearing time.
8. The Sample Size for the Training Set
This study evaluates a medical device (contact lens) directly in a clinical trial and does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, this study does not involve a training set for machine learning or AI. This question is not applicable.
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