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P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 diopters.

The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly). When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in 0.9% saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is available clear or tinted for visibility using phthalocyanine blue, tinted in unique pattern to enhance or alter the apparent color of the eye. Each unique patterns may be distributed under unique or "private label" trade names. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: C.I Reactive Black 5, Titanium Dioxide (TiO2), Carbazole Violet (i.e.,C.I Pigment Violet 23), Phthalocyanine green (i.e.,C.I PIgment Green 7), D&C Yellow No. 10, D&C Red No. 17, [Phthalocyaninato (2-)] Copper (i.e.,C.I PIgment Blue 15).

When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material—in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The provided FDA 510(k) clearance letter and associated documentation for the P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) primarily focus on demonstrating substantial equivalence to a predicate device based on bench testing. This type of submission relies on comparing physical, chemical, and design characteristics, along with performance against established standards, rather than extensive clinical studies or AI algorithm performance.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML medical devices (such as MRMC studies, expert consensus for ground truth on a large test set, etc.) are not explicitly present or applicable in this regulatory context.

However, based on the provided text, I can infer and extract the acceptance criteria and the type of study conducted to prove the device meets these criteria in the context of a 510(k) for contact lenses.

Here's the breakdown:

Acceptance Criteria and Device Performance (P-CON Contact Lenses)

The acceptance criteria for this device are established by demonstrating that its physicochemical, mechanical, and biocompatibility properties are substantially equivalent to a legally marketed predicate device (K221517) and that it complies with relevant ISO standards and FDA guidance for soft contact lenses.

Table 1: Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study performed to demonstrate that the P-CON contact lenses meet the acceptance criteria is primarily a non-clinical bench testing program aimed at demonstrating substantial equivalence to a predicate device and compliance with recognized standards. This is typical for Class II medical devices like contact lenses where a predicate exists and safety/effectiveness can be established through engineering and material characterization rather than clinical trials requiring human subject data for efficacy.

1. Sample Size and Data Provenance for Test Set:

   • Test Set (Bench Testing): The document does not specify exact sample sizes for each bench test (e.g., number of lenses or material samples tested for biocompatibility, oxygen permeability, etc.). This information is typically detailed in the full test reports referenced in the 510(k) submission, not typically summarized in the clearance letter.
   • Data Provenance: The testing was conducted by E.O.S Co., Ltd. (company based in Korea, South). Biocompatibility testing was conducted in accordance with ISO 10993 series and GLP (Good Laboratory Practice) regulations, implying established, documented procedures. Given it's bench testing for a new device, it is prospective in nature (i.e., new tests were performed on the subject device).

2. Number of Experts and Qualifications for Ground Truth for Test Set:

   • Not Applicable in the context of this 510(k). This is not an AI/ML device requiring expert interpretation of images for ground truth. The "ground truth" for contact lens performance is derived from physical measurements (e.g., water content, oxygen permeability), chemical analyses (e.g., material composition), and standardized biological tests (e.g., cytotoxicity assays). These "truths" are established by validated laboratory equipment and protocols, not subjective expert consensus.

3. Adjudication Method for the Test Set:

   • Not Applicable. As mentioned above, "adjudication" is usually for resolving discrepancies in expert human reads, which is not relevant for bench testing of device characteristics. The results are quantitative measurements against defined specifications.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, not done. This type of study is specifically designed for evaluating diagnostic performance of AI or imaging devices with human readers, and it is not relevant for a contact lens 510(k) submission.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   • Not Applicable. This device is a physical medical device (contact lens), not a standalone algorithm.

6. Type of Ground Truth Used:

   • The "ground truth" for this device's performance is established through:
     • Physical and Chemical Measurements: Directly measured properties like water content, oxygen permeability, refractive index, diameter, base curve, etc. against pre-defined specifications or predicate values.
     • Standardized Biocompatibility Assays: Results from tests performed according to ISO 10993 series (e.g., cytotoxicity, sensitization, irritation) against established pass/fail criteria.
     • Predicate Device Comparison: Demonstrating that key characteristics are "substantially equivalent" to a previously cleared predicate device.

7. Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of this 510(k) as it's not an AI/ML device. The device's design and manufacturing process are based on established engineering principles for contact lenses, not a learned model from data.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. No training set was used.

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