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The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic or not-aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The EpiCon K Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:
Chord Diameter: 10.5 mm to 14.0 mm
Center Thickness: 0.10 mm to 0.35 mm
Base Curve: 6.0 to 8.5 mm
Powers: Plano to -20.00 D
Peripheral Curves: A. B. C. D. E. F and G

Here's the analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document describes a 510(k) submission for a Rigid Gas Permeable Contact Lens (EpiCon K) and focuses on demonstrating substantial equivalence to a predicate device (UltraCon S). As such, the structure of the document does not explicitly present "acceptance criteria" in the format one might expect for a novel AI/software medical device. Instead, it argues that the new device's performance is "within the expected range" and "substantially equivalent" to the predicate, based on a clinical evaluation.

Therefore, the response below adapts the requested categories to fit the information presented in this specific 510(k) summary, interpreting "acceptance criteria" as the performance metrics and expected ranges for a contact lens for keratoconus patients.

Acceptance Criteria and Device Performance for EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 38 keratoconic subjects were initially dispensed the EpiCon K lens. 18 subjects (47.4%) completed the 4-week study period.
• Data Provenance: The study was a prospective clinical evaluation conducted at five investigational sites, implied to be within the US, as this is an FDA 510(k) submission.

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

This type of information is not explicitly stated in the provided document. For a clinical study of contact lenses, qualified optometrists or ophthalmologists at each investigational site would have performed the examinations and made clinical judgments, but their specific number, roles in establishing "ground truth," or detailed qualifications (e.g., years of experience) are not provided. The study design implies that clinical observations and measurements from these practitioners served as the data for performance evaluation.

4. Adjudication Method for the Test Set

This information is not explicitly stated. The document mentions that the study was conducted "in accordance with current Good Clinical Practices," which would typically include procedures for data collection and review, but a specific adjudication method (e.g., 2+1) is not detailed. The evaluation likely relied on direct clinical assessments by the investigators at each site.

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 document describes the clinical evaluation of a contact lens, not an AI/software medical device. Therefore, an MRMC study related to AI assistance is not relevant or applicable to this submission.

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

Not Applicable. As noted above, this device is a physical contact lens, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the EpiCon K lens was based on clinical observations, measurements, and patient-reported symptoms by trained ocular health professionals (e.g., optometrists, ophthalmologists) during the 4-week clinical evaluation. This includes:

• Slit lamp findings
• Subject symptom reports
• Complaints/problems
• Keratometry readings
• Refractive measurements
• Visual acuity assessments
• Lens wearing time
• Lens comfort assessments

Comparison was also made against the expected range for keratoconic eyes wearing RGP lenses and against the clinical performance of a predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device (contact lens) and not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant to the described device.

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The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is tinted using D & C Green #6 in an in-monomer tinting process.

The provided text describes a 510(k) submission for a soft contact lens and does not contain information about a device that uses AI or requires a study with expert review, ground truth establishment, or MRMC studies. The text focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of physicochemical properties and safety.

Therefore, I cannot fulfill the request to describe acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not relevant to the provided content.

Here's a breakdown of what is available in the document regarding "acceptance criteria" (more accurately, comparative criteria) and the "study" (non-clinical testing for substantial equivalence):

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

The document presents a comparison between the new device and its predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are essentially that the new device's parameters are comparable to those of the predicate device.

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

The document describes non-clinical testing rather than a typical "test set" for an algorithm.

• Sample Size: Not explicitly stated for specific tests (e.g., how many lenses were tested for Dk, water content, etc.). The statement "Results of cytotoxicity testing show the lens material to be non-cytotoxic. the physicochemical properties of the lens to be comparable to the predicate device, and the leachability testing demonstrates no detectable level of tint in the test extracts." implies that sufficient samples were tested to assert these properties.
• Data Provenance: The testing was "conducted in accordance to the Premarket Notification 510(k) Guidance Document for Class II Contact Lenses issued by FDA in May, 1994." This implies controlled laboratory testing, not patient data from specific countries or retrospective/prospective studies.

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

This is not applicable to this type of device submission. There is no "ground truth" to be established by experts as it's a physical medical device (contact lens) assessed through material and performance testing against established standards and comparisons to a predicate device, not through interpretation of data by human experts.

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

This is not applicable as there is no "test set" in the context of expert review or image interpretation. The evaluation is based on laboratory test results.

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 is not applicable. This is a contact lens, not an AI-powered diagnostic device.

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

This is not applicable. This is a contact lens, not an algorithm.

7. The type of ground truth used:

The "ground truth" for affirming the device's properties is based on physicochemical testing standards and results, and cytotoxicity/leachability assays, compared directly to a legally marketed predicate device as per FDA guidelines for Class II contact lenses.

8. The sample size for the training set:

This is not applicable. There is no "training set" for a physical medical device like a contact lens.

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

This is not applicable.

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The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethy) methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are tinted using Vat Blue #6 in an entrapment tinting process during polymerization of the lens.

Here is an analysis of the acceptance criteria and study information for the Specialty 55 Multifocal and Specialty 55 Single Vision Contact Lenses, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests. Therefore, the "acceptance criteria" are implied to be meeting the performance characteristics of the predicate devices. The table below presents the physicochemical properties of the new device and its predicate devices, where "reported device performance" refers to the values stated for the Specialty 55 lenses.

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

The document does not specify a "test set" in the context of a clinical trial with human subjects for the current device. The studies described are preclinical (laboratory-based) tests. Therefore, information regarding sample size, data provenance, ground truth experts, and adjudication methods for a human subject test set is not provided.

The document mentions that "A series of preclinical tests were performed to demonstrate the safety and effectiveness of the Specialty 55 Multifocal and Specialty 55 (methafilcon A) Single Vision Contact Lenses for Daily Wear". These tests include:

• Systemic Injection
• Primary Ocular Irritation
• Cytotoxicity
• Solution Compatibility
• Dye Extraction for leachability of Vat Blue #6
• Physicochemical testing (e.g., water content, Dk, light transmittance, refractive index, specific gravity)

The provenance of this preclinical data is not explicitly stated but is implied to be from laboratory testing supporting the manufacturer's submission.

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

Not applicable, as a human clinical trial "test set" with expert adjudicated ground truth is not described. The ground truth for the preclinical tests would be based on validated laboratory methods and standards.

4. Adjudication Method for the Test Set

Not applicable, as a human clinical trial "test set" with expert adjudication is not 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. The device is a soft contact lens, not an AI-assisted diagnostic tool.

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

Not applicable, as the device is a soft contact lens, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the safety and effectiveness claims is established through:

• Physicochemical Measurement Standards: For parameters like water content, Dk, light transmittance, refractive index, specific gravity, and powers, the ground truth is based on established scientific and industry standards for contact lens properties.
• Biocompatibility Standards: For systemic injection, primary ocular irritation, and cytotoxicity tests, the ground truth is based on recognized biocompatibility testing standards to determine non-toxicity and non-irritation.
• Chemical Analysis: For dye leachability, the ground truth is established through chemical analysis methods to detect the presence or absence of the dye.
• Compatibility Protocols: For solution compatibility, the ground truth is established via protocols demonstrating material integrity and performance after disinfection with specified solutions.

The overall "ground truth" for the submission is the substantial equivalence to predicate devices that have already been cleared for marketing. This means the new device is deemed safe and effective because its characteristics are sufficiently similar to devices already on the market.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/algorithm-based device and therefore does not have a "training set" in that context. The preclinical tests described would involve specific numbers of lenses or biological samples according to the testing protocols, but these are not considered 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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The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lens may be disinfected using a chemical disinfection system.

The UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 8.5 to 10,5 mm . 0.10 mm to 0.28 mm Center Thickness: . 7.0 to 8.5 mm Base Curve: . +12.00 D to-20.00 D Powers: . The physical/optical properties of the lens are: Specific Gravity 1.105 . 1.57 at 20°C Refractive Index: . 98.5% Light Transmittance: . Hydrophobic Surface Character: . 0.5% Water Content: . 19° (CLMA method) Wetting Angle: . Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) . at 35°C [Fatt method used for determination of oxygen permeability] 2. UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear The UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions: Chord Diameter: 12.0 mm to 14.0 mm Center Thickness: 0.10 mm to 0.28 mm Base Curve: 7.0 to 8.5 mm Powers: +12.00 D to-20.00 D Peripheral Curves: C, D, and E The physical/optical properties of the lens are: Specific Gravity 1.105 Refractive Index: 1.57 at 20°C Light Transmittance: 96.5% Surface Character: Hydrophobic Water Content: 0.5% Wetting Angle: 19° (CLMA method) Oxygen Permeability (Dk): 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg) at 35°C *[Fatt method used for determination of oxygen permeability]

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format as performance metrics against predefined thresholds. Instead, it demonstrates substantial equivalence to a predicate device, implying that meeting or exceeding the predicate's characteristics constitutes acceptance. The "Comparison to Predicate Device" table serves as the primary source for this.

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

• Sample Size for Test Set: Not explicitly stated as a number of subjects. The text mentions a "three month clinical evaluation" and that "Performance of the UltraCon S lens was substantially equivalent to performance of the predicate lens with respect to safety and efficacy." The typical sample size for such a study in the 1990s could range from dozens to a few hundred, but the exact number is not provided.
• Data Provenance: Prospective (clinical evaluation performed at six investigational sites). The country of origin is implicitly the USA, as Specialty UltraVision, Inc. is based in Campbell, CA, and the FDA is the regulatory body.

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

• Number of Experts: Not explicitly stated. The "six investigational sites" suggest multiple clinicians/ophthalmologists were involved in the evaluation, but it doesn't specify if a panel of experts established a ground truth for the test set. Instead, their observations and assessments during the clinical evaluation constituted the "performance" data.
• Qualifications of Experts: Implied to be ophthalmic professionals (e.g., ophthalmologists, optometrists) at the investigational sites, who are qualified to assess contact lens safety and efficacy. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The phrase "clinical evaluation... assessed the safety and effectiveness of the lens" suggests that data was collected, analyzed, and evaluated by the study investigators and then reviewed by the sponsor, but no specific adjudication method (like 2+1 voting) is mentioned.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The study compared the UltraCon S lens's clinical performance to that of a predicate lens, which is a comparative study, but it wasn't presented as an MRMC analysis focused on human reader improvement with AI assistance. This device is a contact lens, not an AI diagnostic tool.
• Effect Size of Human Readers with vs. without AI: Not applicable, as this is a medical device (contact lens) and not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Standalone Performance: Not applicable, as this device is a physical contact lens, not an algorithm.

7. Type of Ground Truth Used:

• For the clinical evaluation, the "ground truth" was established by clinical observation and assessment of safety and effectiveness by qualified ophthalmic professionals at the investigational sites. This includes direct patient examination, reporting of adverse events, and evaluation of visual acuity and lens fit. It's essentially "expert clinical assessment/outcomes data."
• For the non-clinical testing, ground truth was based on standardized in vitro and in vivo toxicology, biocompatibility, and physicochemical tests.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is a medical device (contact lens), not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no AI algorithm being trained.

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The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Soft contact lenses are hemispherical shells manufactured of a copolymer of 2hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolldone (NVP), which yield the appearance of lenses, which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6 mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

This document is a 510(k) Summary for a contact lens device, not a study report describing acceptance criteria and performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present.

However, I can extract the information provided about the device's technical specifications and how its "substantial equivalence" to a predicate device serves as the basis for its market acceptance.

This document does not contain information about:

• Acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for a study.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number/qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (pathology, outcomes data, etc.) for a study.
• How ground truth for a training set was established.

Information Extractable from the Provided Document:

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

The acceptance for this device is based on "substantial equivalence" to a legally marketed predicate device. The document does not describe performance metrics in the way one would for an AI/algorithm-based device (e.g., accuracy, sensitivity, specificity). Instead, it compares the physical, optical, and chemical properties, material, indications for use, and method of manufacture to the predicate device. The "acceptance criteria" here are effectively that these characteristics are sufficiently similar to the predicate to establish substantial equivalence.

2. Sample sized used for the test set and the data provenance:

Not applicable. This is a contact lens submission based on substantial equivalence, not an AI/algorithm study with test sets and data provenance.

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

Not applicable. Ground truth for a test set is not mentioned as this is a device clearance based on substantial equivalence.

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 is not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

For this type of device (contact lens), the "ground truth" for "acceptance" is its physical, chemical, and optical properties and its intended use, which are verified against a predicate device and established material classifications (e.g., FDA Group 1 for materials). There isn't a "ground truth" in the diagnostic or prognostic sense.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

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