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The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable 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 Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who may have 5.00 D or less of astigmatism.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Disposable 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. Lenses shall be discarded upon removal.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available in an aspheric design and manufactured using the castmolding 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 cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization.

The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lenses are available in a light blue tint ([Phthalocvaninato(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 nm), and less than 30% in the UVA range (316 to 380nm).

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 appear somewhat warped; however, 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.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for clinical performance in a tabular format as one might find for a diagnostic AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance of the new device is compared to these predicates across various characteristics to demonstrate similarity.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a separate "test set" sample size for the new device as no independent clinical study was conducted for the device's clinical performance. Instead, it relies on the established clinical performance of the predicate devices.
• Data Provenance: The non-clinical testing (toxicology, biocompatibility, sterility, shelf-life, physical/material properties) was conducted in various laboratories under Good Laboratory Practice (GLP) regulations and scientific protocols. The document does not specify the country of origin for these labs.
• The clinical effectiveness is established by referencing previous clinical performance testing of the etafilcon A material, which means the data provenance for clinical performance is tied to the previous studies of the predicate devices. This indicates a retrospective reliance on existing data rather than a new prospective clinical study for this specific device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided because no independent clinical study was conducted for this specific device to establish new ground truth. The submission relies on the established clinical performance of the predicate devices. Therefore, there's no mention of experts establishing ground truth for a new test set in this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set with adjudicated ground truth was utilized for this device submission. The device's clinical effectiveness is based on the established performance of the predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This device is a contact lens, not an AI or imaging diagnostic device where MRMC studies are typically performed. The purpose of this submission is to demonstrate substantial equivalence to existing predicate contact lenses.

6. Standalone (Algorithm Only) Performance Study

• No standalone performance study was done. This is not an algorithm or AI-based device, so the concept of "standalone performance" for an algorithm doesn't apply. The device itself (a contact lens) is the product.

7. Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness relies on:

• Non-clinical testing results: These include laboratory measurements (e.g., water content, oxygen permeability), cytotoxicity, irritation, and sterility tests. These tests are the "ground truth" for the device's material properties and initial safety.
• Clinical performance established by predicate devices: The document states, "The safety and effectiveness of finished contact lenses manufactured from the etafilcon A material have been established previously through clinical performance testing." This implies that the clinical "ground truth" for this material's performance was established through past clinical trials associated with the predicate devices (e.g., UNICON and Saview-Aqua). This would typically involve patient outcomes, visual acuity measurements, comfort assessments, and adverse event reporting from those prior studies.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (contact lens), not an AI algorithm trained on a dataset. Therefore, there's no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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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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