(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.
§ 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.