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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.

Device Description

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.

AI/ML Overview

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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K Number

K980218

Device Name

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Manufacturer

BIOCOMPATIBLES EYEWEAR, INC.

Date Cleared

1998-03-23

(66 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K941877

Intended Use

LL-55 (methafilcon 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.

Device Description

The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Biocompatibles Evecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses (LL-55):

This submission is a Parametric Release 510(k), which means it focuses on the sterility release mechanism rather than a new device design or clinical performance. The key point is that the lenses themselves remain unchanged from a previously approved 510(k) (K941877). Therefore, the "acceptance criteria" and "device performance" discussed here specifically pertain to the sterilization process validation for parametric release, not the clinical effectiveness or safety of the contact lens as a medical device in terms of vision correction or wear.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Steam Sterilization Process: Capable of achieving more than a 10^-6 sterility assurance level (SAL).	Achieved more than a 10^-6 SAL upon completion of a calculated exposure time of 20 minutes and an exposure temperature of 121°C on normal finished product lenses.
Product Bioburden: Pre-sterilization bioburden consistently and significantly below 1000 vegetative CFU and 40 spore-forming CFU.	Monthly average CFU per pre-sterilized product unit for 5 months (July 1997 to November 1997) ranged from a high of 294 to a low of 29 vegetative CFU, and less than 1 spore-forming CFU.
Bioburden Monitoring Technique Validity: Adequacy of microorganism removal, enumeration, microbiological counting, culture conditions, and recovery efficiency established.	Validation of the process used to determine bioburden included assessment of adequacy of removal, enumeration, counting techniques, culture conditions, and establishment of recovery efficiency for correction factor calculation.
Laminar Flow Workstation Bioburden Level (Airborne): Consistently low results on settle plates.	Results are consistently low.
Laminar Flow Workstation Bioburden Level (Surface): Consistently low results on surface touch plates.	Results are consistently low.
Steam Sterilizer Calibration: Operating within manufacturer design specifications; capable of regulating temperature and displaying/recording pressure.	Sterilizer successfully demonstrated capability to regulate temperature. Pressure gauge successfully demonstrated ability to display and record pressure.
Data Logger Calibration: Output temperatures from 10 validation thermocouple readings deviated less than 1°C from setpoint.	All output temperatures from the 10 validation thermocouple readings deviated less than 1°C from the setpoint.
Pressure Monitoring during Cycle: Pressure held to 15 psi ± 0.5 psi during timing portion of the cycle.	Pressure was held to 15 psi ± 0.5 psi during the timing portion of the cycle.
Annual Sterilizer Calibration & Validation: Verify consistent parameter measurement recordings, consistent operations to specifications, and adequacy of cycle times to achieve 10^-6 SAL.	Annual calibration and validation are performed; recent validation demonstrated compliance with operating specifications and cycle time exceeding time necessary to achieve 10^-6 SAL.
Annual Laminar Air Flow Workstation Certification: Compliance with Federal Standard 209E to Class 100 requirements.	Recent certification demonstrated compliance with Federal Standard 209E to Class 100 requirements.

Study Details (Focusing on Sterilization Validation)

Sample size used for the test set and the data provenance:
- Steam Sterilization Validation: "Normal finished product lenses" were used, but a specific sample size for this part of the test is not explicitly stated. The validation demonstrated the process's capability.
- Product Bioburden Monitoring: Bioburden results were obtained "monthly over a 5 month period" (July 1997 to November 1997). The number of product units sampled per month for bioburden is not specified, only the average CFU per unit.
- Thermocouple Readings: 10 validation thermocouple readings were used for data logger calibration.
- Data Provenance: Retrospective, based on internal validation and monitoring data from Biocompatibles Eyecare Inc. (USA). This is typical for process validation data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a process validation study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" here is objective physical and microbiological measurements demonstrating sterility assurance.
Adjudication method for the test set:
- Not applicable. This is a scientific and engineering validation of a sterilization process, relying on quantifiable measurements and established standards (e.g., SAL). There is no "adjudication" in the sense of resolving discrepancies between human readers.
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 is a sterilization process validation for a contact lens, not a diagnostic AI device requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is about the process of sterilization and its parametric release, not an algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on scientific and engineering measurements against established standards for sterilization (e.g., 10^-6 SAL, specific temperature, pressure, and time parameters), and microbiological assays to quantify bioburden.
- It relies on calibrated equipment and validated microbiological testing methods.
The sample size for the training set:
- Not applicable. This is a process validation, not a machine learning model's development. There is no "training set" in this context. The underlying principles for determining sterilization parameters are based on extensive scientific literature and regulatory guidelines, not a specific training dataset for this device.
How the ground truth for the training set was established:
- Not applicable. See point 7.