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The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The Desio (hioxifileon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses 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 disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from hioxifilcon D, which is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA), and cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, C.I. Reactive black 5.

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. When producing the tinted lenses, the pad-printing manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives 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 pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >67% in the UVA range (316nm - 380nm).

The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses will be manufactured in the sphere and toric design configurations.

Here's a breakdown of the acceptance criteria and the study information for the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses, based on the provided text:

Acceptance Criteria and Reported Device Performance

*Note: The "Tolerance" column is directly from the provided text and represents the acceptance criteria for each parameter. The "Reported Device Performance" column directly states the device's measured or designed values for these parameters. The document implies that the device performance meets these tolerances without explicitly stating "passed" for each one.

Study Details

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

   • The document describes non-clinical testing including toxicology, shelf-life, and physicochemical & mechanical properties. However, it does not specify explicit sample sizes for these tests beyond general statements like "A series of preclinical testing was performed."
   • Data Provenance: The toxicology tests were conducted "in accordance with the GLP regulation." The overall testing was conducted in laboratories, with the data determined to be scientifically valid under 21 CFR 860.7. No specific country of origin for the test data is mentioned, but the submitter is Qualimed SRL in Italy. The tests are considered retrospective as they are performed on the manufactured product to demonstrate its properties.

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

   • No information is provided regarding experts establishing ground truth for the non-clinical tests. These tests typically rely on standardized laboratory procedures and measurements rather than expert human interpretation.

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

   • Not applicable/Not mentioned, as the reported tests are objective measurements for physical and chemical properties and toxicology, not requiring adjudication of human interpretations.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This device is a contact lens.

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

   • Not applicable. This device is a contact lens, not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is based on objective measurements and standardized test protocols. For example:
     • Cytotoxicity: Measured by ISO 10993-5.
     • Systemic Toxicity: Measured by ISO 10993-11.
     • Acute Ocular Irritation: Measured by ISO 10993-10.
     • Physicochemical & Mechanical Properties: Measured to assess refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals against established material standards (implied, as they support substantial equivalence).

7. The sample size for the training set:

   • Not applicable. This document describes the testing for a physical medical device (contact lenses) and does not involve AI or machine learning algorithms that require training sets.

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

   • Not applicable, as no training set was used.

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The DESIO (polymacon) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The DESIO (polymacon) 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 not exceeding 4.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses 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 disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

The DESIO soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. All lenses containing dioptric powers outside +/- 10.00 D and toric lenses are lathe-cut to specified Rx. The DESIO soft contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

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 co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).

DESIO lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), [Phthalocyaninato(2-)] Copper, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, C.I. Reactive black 5.

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. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The color additives 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 pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.

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 or colored 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 physical properties of the lens are: Refractive Index 1.43, Light Transmission (clear) greater than 96%, Light Transmission (tinted) greater than 96% (at region corresponding to pupil); Opaque or 0-10% (at region corresponding to iris), Surface Character hydrophilic, Water Content 38±2%, Specific Gravity 1.17 (hydrated), Oxygen Permeability 12.48 x 10-11 (cm²/sec)(mlO2)/(ml x mmHg @ 35°C)) (revised Fatt method).

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in spherical and toric configurations with the following features and properties: Chord Diameter: 12.80 mm to 15.00 mm, Center Thickness: 0.050 mm to 0.210 mm, Base Curve: 8.0 mm to 9.8 mm, Power Range Cast-molded: -10.00D to +10.00D in 0.25D steps, Lathe-cut: -20.00D to -10.00D & +20.00D to +10.00D in 0.25D steps, Cylinder Power (Toric): -0.25D to -4.00D in 0.25D steps (lathe-cut), Cylinder Axis (Toric): 10° to 180° in 10° steps.

DESIO lenses are supplied in blister packages with a base made from polypropylene and a laminated foil seal on top. The lenses are supplied sterile in Polyhexamethylene Biguanide (PHMB) containing saline solution. Blister package labeling is printed with the 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.

The provided document is a 510(k) summary for the DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific acceptance criteria in a clinical study against a hard defined set of endpoints.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically associated with a new technology demonstrating its performance against a predefined benchmark. Instead, it focuses on demonstrating equivalence to an existing device.

However, I can extract information related to the device's properties and the basis for its safety and effectiveness claims.

Here's a breakdown of the requested information based on the provided document, acknowledging the type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there are no explicit "acceptance criteria" in the sense of predefined performance thresholds for a novel device's efficacy. The acceptance is based on demonstrating substantial equivalence to a predicate device in terms of intended use, materials, physical construction, and safety/effectiveness.

The table below summarizes key physical properties of the DESIO lenses, which are implicitly acceptable because they are equivalent to the predicate device.

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

• Test Set Sample Size: The document explicitly states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that NO new clinical test set data was collected for this specific 510(k) submission to demonstrate performance beyond the inherent properties of the material and device design. The "testing" referred to primarily consisted of non-clinical (in vitro and in vivo toxicology, biocompatibility, stability) studies.
• Data Provenance: Not applicable for a new clinical test set. The non-clinical studies (toxicology, microbiology, chemistry, shelf-life stability) were conducted by "Several laboratories under Good Laboratory Practice regulations" (page 7). The country of origin for these labs is not specified.

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

• Not applicable as no new clinical test set was used for performance validation in this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable as no new clinical test set was used for performance validation.

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

• No MRMC comparative effectiveness study was done. This type of study (comparing human readers with and without AI assistance) is not relevant for a contact lens approval, which focuses on physical, material, and biocompatibility properties, and visual correction.

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

• Not applicable. This is not an AI or algorithm-based device.

7. Type of Ground Truth Used

• For the non-clinical studies: The "ground truth" would be established by standard scientific and regulatory methods for evaluating sterility, toxicity, biocompatibility, and physical properties (e.g., meeting established chemical and biological markers, physical measurements, and stability over time).
• For the overall device approval: The "ground truth" for substantial equivalence is derived from the established safety and effectiveness profile of the predicate device (ISENS by Vision Science Co., Ltd., 510(k) number; K132714) and the scientific understanding of the polymacon material.

8. Sample Size for the Training Set

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

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

• Not applicable as there is no "training set" for this device.

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