Search Results

The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and early presbyopia up to 1.25 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with disposal as recommended by the eyecare practitioner. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The HD/HDT, (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives.

Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126)

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:

1.445 (hydrated) Refractive Index greater than 90% Light Transmission (clear) Light Transmission (tinted) greater than 90%

Water Content 38 % ± 2% Oxygen Permeability 8.4 X 10-1 (cm /sec) (ml O /ml x mm Hg @ 35 C), (revised Fatt method).

The provided document does not contain information about acceptance criteria and a study proving a device meets them in the context of device performance, as it is a 510(k) Summary for a soft contact lens aiming for clearance based on substantial equivalence to predicate devices rather than a performance study with acceptance criteria.

The 510(k) summary focuses on demonstrating that the HD/HDT (polymacon) Soft Contact Lens for Daily Wear is substantially equivalent to previously cleared devices. It does not present a new clinical study with specific performance metrics and acceptance criteria for the device itself. Instead, it leverages existing data and the substantial equivalence pathway.

Therefore, many of the requested categories cannot be populated.

Here's a breakdown of the available information and why other fields cannot be filled:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the context of a new performance study for the HD/HDT lens. The submission relies on the established safety and performance profiles of the predicate devices.
• Reported Device Performance: Not presented as a distinct set of performance metrics from a new study in this document. The document primarily details the physical properties of the lens material (water content, oxygen permeability, refractive index, light transmission) and states that its toxicity is "Non-Toxic," which are material characteristics rather than performance metrics against acceptance criteria in a clinical study.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. There is no specific "test set" for a new performance study described. The document refers to pre-clinical data (cytotoxicity, systemic injection, ocular eye irritation) from a previously cleared device (K013220).
• Data Provenance: The pre-clinical data is referenced from K013220. No country of origin or retrospective/prospective nature is specified for this referenced data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new test set or ground truth establishment by experts is described for this submission.

4. Adjudication method for the test set:

• Not applicable. No new test set or adjudication process is described.

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. This device is a soft contact lens, and an MRMC study with AI assistance is irrelevant to its intended use and the nature of this 510(k) submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

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

7. The type of ground truth used:

• Not applicable in the context of a new performance study. The safety profile is established through pre-clinical toxicology and manufacturing/chemistry data referenced from previous 510(k) submissions (K013220, K002099).

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set.

Summary of what the document does provide regarding device evaluation:

• Pre-Clinical Performance Data: The document explicitly states that "Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test can be referenced in the 510(k) # K013220." This indicates that these standard safety tests were performed and documented in a prior submission, and the current device leverages those results due to material similarity.
• Substantial Equivalence: The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (K013220, K982110, K980818) based on:
  • Similar indications for use (with the addition of "early presbyopia up to 1.25 diopters").
  • Target population.
  • Hydrophilic materials (polymacon).
  • Physical construction.
  • Established safety and effectiveness profiles of the predicate devices.
  • A table (Substantial Equivalence Matrix) compares the subject device with predicates on manufacturing, indications, intended use, manufacturing method, USAN name/material, water content, and toxicity.

In conclusion, this 510(k) summary is for a contact lens seeking clearance based on substantial equivalence, not a new performance study that would entail detailed acceptance criteria, test sets, or ground truth establishment as typically found in submissions for novel or complex devices requiring extensive new performance data.

Ask a specific question about this device