Search Results

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be hand painted in an iris or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of lenses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.

This document is a 510(k) summary of safety and effectiveness for a medical device called "Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear." It's a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the requested information, based on the provided text:

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

The provided 510(k) summary does not contain a table of explicit acceptance criteria or reported device performance in terms of quantitative metrics (e.g., success rates, accuracy, sensitivity, specificity). Instead, it relies on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" can be inferred from the comparison table, which highlights the similarities in intended use, indications for use, opacity, color additive characteristics, and opaquing agent. The "performance" is implicitly stated as being equivalent to the predicate device, thereby meeting the safety and efficacy standards.

Here's a table summarizing the comparison, which serves as the basis for demonstrating equivalence rather than a set of performance metrics:

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

The document does not describe a test set or clinical study with a specific sample size. This 510(k) is based on demonstrating substantial equivalence to an existing device, implying that the safety and effectiveness are established through the predicate's history, not new clinical testing for this specific device model. Therefore, there is no mention of data provenance.

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)

Not applicable, as no new clinical study or test set requiring ground truth establishment is described.

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

Not applicable, as no new clinical study or test set is described.

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 a contact lens, not AI software.

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

Not applicable. This is a contact lens, not AI software.

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

Not applicable, as no new clinical study or test set is described. The "ground truth" for the device's acceptable performance is its substantial equivalence to a previously cleared device.

8. The sample size for the training set

Not applicable. This is a physical medical device (contact lens), not a machine learning algorithm.

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

Not applicable. This is a physical medical device (contact lens), not a machine learning algorithm.

Ask a specific question about this device

Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacles that have been precision coated with varying hue and saturation filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. ChromaGen v30 Reading Aid & Color Discrimination Enhancement are available in varying hues and saturation levels duplicate of that available in the ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Soft Contact Lenses. The ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lens has been designed for binocular use, and when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.

Here's an analysis of the provided text regarding the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lenses, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the ChromaGen v3.0 Spectacle Lenses. Instead, the basis for clearance is substantial equivalence to previously cleared predicate devices (ChromaGen v3.0 Reading Aid Soft Contact Lenses (K012132) and ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses (K994320)).

The reported device performance, in this context, is that the ChromaGen v3.0 Spectacle Lenses achieve "Substantially Equivalent" efficacy to the predicate soft contact lenses.

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

• Test Set Sample Size: No new clinical studies were conducted for the ChromaGen v3.0 Spectacle Lenses directly. The submission relies on the efficacy established in the predicate contact lens studies (K994320 & K012132). Therefore, the sample size for a new test set for these spectacle lenses is 0.
• Data Provenance: Not specified within this document for the original predicate studies. However, the applicant is based in England. The 510(k) is submitted to the US FDA. We can infer the predicate studies (K994320 & K012132) were likely either performed in the UK or internationally, and were considered acceptable by the FDA for the previous contact lens clearances. This is a retrospective reliance on previously established data.

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

• Since no new studies were conducted, there were no new experts specifically used to establish ground truth for a new test set for these spectacle lenses. The ground truth for the predicate contact lens studies is not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable, as no new test set was created or adjudicated for these spectacle lenses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done for the ChromaGen v3.0 Spectacle Lenses. The document explicitly states: "Clinical performance studies are not required for the spectacle version of the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132."
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable as this is not an AI device, and no MRMC study was performed.

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

• Not applicable. This device is a physical spectacle lens with colored filters and is not an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the efficacy of the predicate contact lenses (which this device relies upon) was established via "Clinical study" as stated repeatedly in the table. The specific type of clinical outcome or assessment used to establish efficacy (e.g., improved reading speed, improved scores on color vision tests, patient-reported outcomes) is not detailed in this 510(k) summary but would have been part of the K994320 and K012132 submissions.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical medical device.

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

• Not applicable. As stated above, this device does not utilize a training set.

Ask a specific question about this device

The ChromaGen v3.0 Reading Aid Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.

Theses lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are a range of soft lenses with precision tinted I ho on onlying hue and saturation which, when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the encoufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.

The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used in and paragraph with (pation are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v3.0 Reading Aid, Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.

Acceptance Criteria and Study for ChromaGen v3.0 Reading Aid Soft Contact Lens

This response details the acceptance criteria and the study conducted to demonstrate the effectiveness of the ChromaGen v3.0 Reading Aid Soft Contact Lens, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses are indicated for daily wear to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes. The lenses are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

The ChromaGen v2.0 Color Discrimination Enhancement filters are designed specifically to improve discrimination between colors that are normally confused by people with protan or deutan (red-green) color vision deficiencies. The ChromaGen v20 Color Discrimination Enhancement Soft Contact Lenses are a range of soft contact lenses with precision tinted pupils of varying hue and saturation which, when used monocular and binocularly, have been shown to be of use in patients with defective color vision. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This device in not a cure for color vision deficiencies or colorblindness. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses are tinted to the eyecare professional instructions. The ChromaGen color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethy) methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lenses tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.

The provided text is a 510(k) summary for the "ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens". It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria and a detailed study report for the device itself.

Therefore, much of the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a performance study) is not available in the provided document.

The document primarily describes the device's characteristics and compares them to predicate devices, focusing on materials, manufacturing, intended use, and general safety aspects (like color additives). It does not contain a study designed to quantify the "enhancement of color discrimination" with specific metrics against defined acceptance criteria.

However, I can extract the available information:

• Device Name: ChromaGen v2.0 Haploscopic System & Color Discrimination Enhancement Soft Contact Lens
• Intended Use: To enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.

Not Applicable/Not Provided due to the nature of the 510(k) summary:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for substantial equivalence, not a performance study against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test set or study data is presented to evaluate clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical performance study is detailed with a test set and ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI-powered diagnostic tool; it's a contact lens.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study for color discrimination enhancement is described with a ground truth methodology. The document mentions improvement in discrimination based on the design of the filters and previous device history.
8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring 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 PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted to the eyecare professional instructions.

The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 19, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.

Tint Patterns Available:

1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
4. Tinted lens with Black Pupil. Uses the CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cantor & Silver 5X Prosthetic Tinted Soft Contact Lens:

Acceptance Criteria and Device Performance:

The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for specific performance metrics. Therefore, explicit "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial with quantitative endpoints are not present. Instead, substantial equivalence is claimed based on comparable intended use, indications, and material/manufacturing characteristics.

The table below summarizes the characteristics presented for substantial equivalence. The "Acceptance Criteria" column reflects the implicit criteria for being considered substantially equivalent (i.e., being similar to the predicate device), and the "Reported Device Performance" column reflects the characteristics of the subject device.

Study Details:

The provided document does not contain information about a specific clinical study with quantitative performance metrics to "prove the device meets acceptance criteria" in the way one might expect for a new device claiming superiority or unique performance. Instead, the submission is based on substantial equivalence to existing legally marketed devices.

Therefore, many of the requested study-specific details are not applicable or explicitly stated in this 510(k) summary.

1. Sample size used for the test set and the data provenance: Not applicable. No specific "test set" or clinical study with patient data detailed in this 510(k) summary. The comparison is against characteristics of predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" derived from expert consensus on a test set is mentioned.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for study data is mentioned.
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: Not applicable. This device is a contact lens, not an AI diagnostic tool, so an MRMC study is irrelevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for the substantial equivalence claim would be the established characteristics and regulatory approval of the predicate devices.
7. The sample size for the training set: Not applicable. No "training set" is mentioned as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The CANTOR & SILVER SX Tinted (hioxifilcon A) 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 leases 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 disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.

The CANTOR & SILVER 5X Tinted (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-disessed eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.

The CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact lens are fabricated from hioxifilcon A, 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 color enhanced soft contact lenses are tinted with "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The finted contact lenses are available in a light, medium or dark shade of the following enhance colors; Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet, and Amber.

The color additive (timing) effect is formed by reacting one or more of the "listed" additives with HEMA based (poly hydroxyethy) methacrylate) soft contact lens. The color additives used are not removed by lens handling and cleaning/disinfecting procedures as recommended. Except for affecting the amount of light transmitted through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

In the bydrated state, the lens conforms to the curvature of the eye covering the comea and extending slightly beyond the limbus forming a transparent optical surface. The (hioxifilcon A) soft hydrophilic contact lens 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.

This document is a 510(k) premarket notification for a contact lens, which means it's focused on demonstrating substantial equivalence to existing devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, the information regarding acceptance criteria, specific study designs, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, as typically sought for AI/ML device evaluations, is not present in this type of submission.

Instead, the submission focuses on comparing the new device's characteristics to a predicate device (Durasoft 2 Colors) to demonstrate that it does not raise new questions of safety or effectiveness.

Here's a breakdown of what is available, and what is not:

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

• Acceptance Criteria (Implicit): The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning the new device's characteristics (materials, production method, lens function, color additives, and use restrictions) are similar enough to an already approved device that it's considered equally safe and effective.
• Reported Device Performance: Instead of performance metrics, the document provides the physical properties and characteristics of the CANTOR & SILVER 5X Tinted contact lens, and then compares them to the predicate device to show similarity.

Here's the table from the document, re-formatted to highlight the comparison for "performance" in this context:

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

• Not Applicable: This submission does not describe a clinical performance study with a test set in the way a modern AI/ML device would. The "study" here is essentially a technical comparison and declaration of equivalence.

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):

• Not Applicable: There is no "ground truth" establishment in the context of expert consensus for a test set described. The ground truth for regulatory approval is the established safety and effectiveness of the predicate device and the new device's proven similarity to it through material science, manufacturing, and toxicology data.

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

• Not Applicable: No test set adjudication method is described.

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:

• No: This is a contact lens, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.

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

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

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

• Implicit Ground Truth: The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Durasoft 2 Colors) and general scientific understanding of contact lens materials and manufacturing. The manufacturer is demonstrating that their new device is functionally and materially similar enough to the predicate that it can rely on its established safety profile. This includes:
  • Pre-clinical toxicology and manufacturing/chemistry data (K952620, referenced for BENZ-G 5X).
  • Material properties (hioxifilcon A) being well-understood.
  • Manufacturing processes (lathe-cut) being standard and controlled.

8. The sample size for the training set:

• Not Applicable: There is no machine learning "training set" for a contact lens.

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

• Not Applicable: As above, no machine learning training set or ground truth establishment in that context.

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