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The Etafilcon with Tangible Coating (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The Etafilcon with Tangible Coating (etafilcon A) TORIC Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism.

The Etafilcon with Tangible Coating (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Wear Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.

Eye care professionals may prescribe the lenses for daily disposable wear. The contact lenses should be discarded upon removal.

The Etafilcon with Tangible Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is available in an aspheric design and manufactured using the cast-molding process. The lenses consist of 58% water and 42% etafilcon A. The lens material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which are crosslinked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.

The Etafilcon with Tangible™ Coating (etafficon A) Soft (Hydrophilic) Daily Wear Contact Lenses are available in a light blue tint ([Phthalocyaninato(2-)]copper) for visibility and handling. The lenses also contain a Benzotriazole ultraviolet (UV) absorbing monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range (280 to 315 mm), and less than 30% in the UVA range (316 to 380nm).

The Etafilcon with Tangible "M Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is treated to incorporate Tangible TM Coating Technology-which is a thin biocompatible polymer that is covalently bonded to the surface of the contact lens.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (etafilcon A) soft hydrophilic contact lens has an aspheric 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; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The lenses are supplied sterile in blister packages containing a buffered saline solution. Package labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

This document describes the premarket notification (510(k)) for the "Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens." It asserts substantial equivalence to predicate devices and describes the non-clinical and previous clinical performance testing. However, it does not contain specific acceptance criteria with reported device performance in a table format for a diagnostic device. Since this is an approval for a contact lens, the nature of the "acceptance criteria" and "device performance" differ significantly from what would be expected for a diagnostic AI/ML device.

Based on the provided text, here's an attempt to answer the questions, focusing on the information available regarding the contact lens rather than an AI/ML diagnostic system:

1. A table of acceptance criteria and the reported device performance

   The document does not present acceptance criteria or reported device performance for an AI/ML diagnostic in a table. Instead, it describes general safety and performance characteristics for a contact lens. The "performance" for this device relates to its physical properties and biocompatibility.

   Acceptance Criteria (Implied from the document goals)	Reported Device Performance (from the "Testing" section)
   Lenses are sterile for the indicated shelf-life.	Confirmed: "Lenses supplied in blister packages are sterile for the indicated shelf-life."
   Finished lenses, packaging material, and extracts are non-toxic and non-irritating.	Confirmed: "The finished lenses, packaging material and extracts are non-toxic and non-irritating." (Based on in vitro and in vivo preclinical toxicology and biocompatibility tests)
   Lens physical and material properties are consistent with currently marketed lenses.	Confirmed: "Lens physical and material properties are consistent with currently marketed lenses." (Based on non-clinical testing)
   Safe and effective for indicated use when compared to predicate devices.	Confirmed: "The Etafilcon with Tangible™ Coating (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is as safe and effective as the predicate device..."
   Clinical performance has been established.	Confirmed: "The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing."
   Physical properties (Water Content, Oxygen Permeability, Specific Gravity, etc.)	Water Content: 58 ±2%

Oxygen Permeability: 24.1 x 10-11 (cm²/sec)(ml O2/ml-mmHg)
Specific Gravity: 1.14 (hydrated)
Refractive Index (wet): 1.404
Visible Light Transmission: >90% |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document mentions "a series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed." It also states, "The safety and effectiveness of finished contact lenses manufactured from the (etafilcon A) material has been established previously through clinical performance testing." However, specific sample sizes for these tests (whether animal or human subjects for the "clinical performance testing") are not provided. The data provenance (country, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This information is not applicable and not provided in the document as it pertains to a contact lens, not an AI/ML diagnostic system requiring expert-adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device with a test set requiring adjudication.

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

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device.

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

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device. The device itself is the contact lens, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   For the contact lens, the "ground truth" for safety and effectiveness appears to be established through:

   • Biocompatibility and toxicology studies (in vitro and in vivo) to confirm non-toxicity and non-irritation.
   • Sterility testing to confirm shelf-life.
   • Physical and material property measurements compared against known acceptable ranges for contact lenses.
   • Previous clinical performance testing of the etafilcon A material.

8. The sample size for the training set

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device that requires a training set.

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

   This information is not applicable and not provided in the document, as it is not an AI/ML diagnostic device that requires a training set.

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