Search Results

The Extreme H2O® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

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

Extreme H2O® 54% (hioxifilcon D) soft contact lenses are hemispherical shells and are available as spherical (G54 13.6 and G54 14.2) or toric (G54 Toric) lens designs. The Extreme H2O® 54% (hioxifilcon D) soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium borate. The lens is available with a blue visibility handling tint. phthalocyanato (2) - (copper).

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 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.

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Extreme H2O® 54% (hioxifilcon D) Soft Contact Lens for Daily Wear

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on a comparison to a predicate device (59% Extreme H2O® (hioxifilcon A) soft contact lens) and chemical/physical/toxicological testing to establish substantial equivalence. Direct "acceptance criteria" and "reported performance" for specific clinical outcomes are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" are implied by demonstrating that the new device's material properties fall within the range of, or are comparable to, already cleared materials and predicate devices.

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

• Test Set Sample Size: Not applicable in the context of a clinical study. The "test set" here refers to the new device (Extreme H2O® 54%), which underwent material characterization and toxicology testing.
• Data Provenance: The toxicology tests were performed on the Extreme H2O® 54% material (hioxifilcon D). The document implies these were standard ISO tests. The country of origin and whether the data was retrospective or prospective is not specified for these specific tests, but they are generally carried out prospectively as part of product development.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, was not established for this submission. The "ground truth" for the material properties and toxicology was based on established scientific and regulatory standards for material characterization and pre-clinical safety testing (e.g., ISO standards for toxicology).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a contact lens, not an AI algorithm. Its performance is inherent to the physical and chemical properties of the lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on:

• Material Characterization: Scientific measurements of properties like water content, refractive index, light transmission, specific gravity, and oxygen permeability.
• Toxicology Data: Results from standardized ISO safety tests (Systemic Injection Test, Agar Diffusion Test, Primary Ocular Irritation).
• Substantial Equivalence to Predicate Device: The established safety and effectiveness of the legally marketed predicate device(s) (59% Extreme H2O® (hioxifilcon A) and Benz-G 3X (hioxifilcon B)).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable.

Ask a specific question about this device

The CANTOR & SILVER 5X (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens 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 CANTOR & SILVER 5X (hioxifilcon A) Toric 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/or possesses refractive astigmatism up to 10 Diopters.

The CANTOR & SILVER 5X (hioxifileon A) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon A, which in the dry (unhydrated) state may be machined. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

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 (hioxifileon A) 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 58% water by weight. The physical properties of the lens are:

Refractive Index: 1.515 (dry) 1.404 (hydrated)
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Color Pigment Name: Phthalocyanato (2) - (copper)
Water Content: 58% ± 2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 20 X 10 to the power of -11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method)

The provided text describes the CANTOR & SILVER 5X (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets. Instead, it demonstrates substantial equivalence to predicate devices by comparing manufacturing methods, lens function, and material properties. The "performance" here is an assertion of similarity.

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

The document describes a comparison against predicate devices to establish substantial equivalence, not a performance study that would typically involve a "test set" of patients or data. Therefore, information about a test set sample size or its provenance (country of origin, retrospective/prospective) is not applicable in this context. The study is a comparison of product specifications and characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since this is a submission for substantial equivalence based on material properties and manufacturing, there was no "test set" requiring ground truth established by experts. The claims rely on the established properties of the materials and the manufacturing process, which are compared to the predicate devices.

4. Adjudication Method for the Test Set

As there was no test set in the sense of clinical performance data requiring expert review, an adjudication method is not applicable.

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

An MRMC study is relevant for evaluating the performance of AI systems or interventions where human readers are involved in assessing cases. This submission is for a contact lens, which is a medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study was not done, and there is no effect size related to human readers improving with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

This concept is applicable to AI and diagnostic algorithms. The CANTOR & SILVER 5X contact lens is a physical medical device. Therefore, a standalone (algorithm only) performance study was not done.

7. Type of Ground Truth Used

The "ground truth" in this context is the established specifications and properties of the predicate devices and the materials used. The substantial equivalence argument rests on matching these characteristics.

8. Sample Size for the Training Set

There is no "training set" as this is not an AI or machine learning device. The product development would involve engineering and material science, not data-driven model training.

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

As there is no training set, this question is not applicable.

Ask a specific question about this device

BENZ 38 (polymacon) Spherical soft (hydrophilic) contact lenses in clear or with blue visibility tint form are indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters and masking up to 1.50' Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) Toric soft (hydrophilic) contact lenses in clear or with blue visibility tint form are also indicated for daily wear. The lenses are indicated for the correction of visual acuity in non-aphakic patients with with non-The spherical lenses are being applied for diseased eyes. from +12.00 to -20.00 Diopters up to 4.50 Diopters of astigmatism where it does not interfere with visual acuity.

BENZ 38 (polymacon) lens can be lathed into a spherical soft (hydrophilic) contact lens which becomes a hemispherical shell. The non-ionic material, hioxifilcon A is an ultra high molecular weight homo-polymer of 2-hydroxyethyl methrylate (2-HEMA). This material is made from extremely high purity monomer using state of the art polymer synthesis technique. It consists of 62% hioxifilcon A and 38% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The lens made from BENZ 38 (polymacon) when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina. BENZ 38 with the visibility tint was subjected to leeching tests and showed no identifiable evidence of leeching.

The clear BENZ 38 (polymacon) optical buttons are identical to the polymacon optical buttons made by Benz Research and development in PMA P830012/S04 approved June 5, 1990. The pigment used in the BENZ-38 Blue Visibility tinted buttons and in BENZ-38 blue visibility tinted lenses is identical to the pigment used in K952620 BENZ-G 55 (hioxifilcon A) Class II Soft(hydrophilic) contact lenses Class 86-IPL, approved DEC. 1, 1995.

This document is a 510(k) notification for a contact lens material (BENZ 38 polymacon), not a device that relies on AI algorithms, human readers, or expert adjudication for its performance. Therefore, many of the requested elements for an AI/ML-based device study are not applicable.

However, I can extract information related to the device performance and the studies conducted to demonstrate safety and effectiveness for this type of medical device (contact lenses).

Here's the information, adapted to fit the context of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for specific tests (e.g., toxicology, microbiology, clinical studies). It refers to studies conducted for previous approvals (P830012/S04 in 1990 for clear lenses and K952620 in 1995 for pigment similarity).

• Sample Size: Not specified in the provided text.
• Data Provenance: Studies were conducted by Benz Research and Development, Inc. and Unilens Corp. USA. The data is retrospective in the sense that it relies on previously conducted and approved studies for the base material (clear) and the pigment (visibility tint). No specific country of origin for the human subjects or specimens is mentioned, but the companies are US-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not directly applicable to a contact lens material approval. "Ground truth" in this context would be established by laboratory testing methods and clinical observations, not by expert consensus on interpretations of images or data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for contact lens material approval is based on:

• Laboratory Bench Testing: This includes toxicology assays, microbiology testing, lens compatibility tests, preservative uptake tests, and leeching tests, which produce objective measurements and results.
• Clinical Study Outcomes: Observations of patient safety, comfort, and visual acuity in human subjects wearing the lenses. These are typically assessed against pre-defined safety and efficacy endpoints.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device. The "training set" concept doesn't apply here; rather, the material's properties are established through a series of physical, chemical, and biological tests.

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

Not applicable. As above, this is not an AI/ML device. The "ground truth" for the material's performance relies on rigorous testing protocols and accepted scientific methodologies for contact lens materials, rather than a "training set" in the AI sense.

Ask a specific question about this device