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The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the corrective 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 Iqel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eves who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of +4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.

The Igel 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is 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 that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. 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 disinfecting systems.

The Igel 55 UV, the Igel 55 UV Multifocal, and the Igel 55 UV Toric Daily Wear Contact Lenses (methafilcon A) are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Igel 55 UV Contact Lens is available in a single vision lens design, the Igel 55 UV Multifocal Contact Lens is available in an aspherical lens design, and the Igel 55 UV Toric Contact Lens is available in a back surface toric design. 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%). A UV absorbing compound has been incorporated into the lens polymer. All lenses are tinted using the color additive Reactive Blue #19.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IGEL Visioncare contact lenses, formulated to answer your specific questions.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with detailed performance metrics and statistical analyses typically associated with novel device approvals. Therefore, some of your requested information (e.g., specific effect sizes, adjudication methods for clinical studies with human readers, specific training set details, or sample sizes for clinical trials if not explicitly mentioned) may not be present or directly inferable from this type of regulatory document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices. The performance criteria are the physicochemical properties that are compared directly to the predicate devices.

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The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.

The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to -12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps). The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.

The provided text describes the Igel® 56 UV (hefilcon C) Soft (hydrophilic) Contact Lens and its clinical study for substantial equivalence to other marketed lenses. However, it does not explicitly state "acceptance criteria" in a tabulated format with corresponding "reported device performance" as requested in point 1. The document primarily focuses on establishing substantial equivalence based on safety and efficacy, assessed through the absence of adverse reactions, improvement/maintenance of slit lamp findings, resolution of symptoms, and maintenance of visual acuity and lens cleanliness.

Here's an attempt to extract and infer the closest information to
1. A table of acceptance criteria and the reported device performance

• Initial "No Findings" (51.4%) increased to "No Findings" (58.6%).
• Neovascular decreased from 18.9% to 11.4%.
• Tarsal decreased from 48.6% to 40.0%. |
  | - Resolution or non-worsening of symptoms, problems, and complaints (e.g., lens awareness, handling, reading problems) | - "Symptoms, problems and complaints were reported by the investigators at each visit."
• "NONE" (62.6%). Other reported: "Lens Awareness" (14.5%), "Handling Problems" (8.4%), "Reading Problems" (7.9%). The document implies these were not considered disqualifying for substantial equivalence. "The 'other' symptoms were dryness (reported by 2 subjects); torn lenses reported by 1 subject." |
  | - Low discontinuation rate | - "Throughout the study, 2 subjects (5.4%) were discontinued." (Implied acceptable for substantial equivalence). |
  | Efficacy: | |
  | - Maintenance of visual acuity (within 1 line of initial best corrected acuity, where appropriate) | - "All but 2 eyes had a final visual acuity within 1 line of the initial best corrected acuity. The appropriate acuity was achieved by all eyes, since those two eyes were in subjects fit for monovision." |
  | - Acceptable wear time | - "Wear time remained essentially unchanged over the one month of the study, indicating continuing comfort and cleanliness with the investigational solution." |
  | - Good lens cleanliness (e.g. clinically clean) | - "91% of test lenses were clinically clean during the study. (Rudko grades I and II are considered clinically clean.)" |

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

• Sample Size: 37 subjects. 35 (94.6%) completed 1 month of wear.
• Data Provenance: The study was conducted from July 11, 1997, to August 19, 1997. The location is not explicitly stated, but the submission is from "Igel Vision Care PTE, Ltd, Singapore" with an agent in Chicago, IL, USA. This suggests a prospective clinical trial, although the specific country of origin of the subjects is not detailed.

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

• Number of experts: The study involved two (2) investigators.
• Qualifications of experts: The document does not specify their exact qualifications (e.g., "radiologist with 10 years of experience"). However, being "investigators" in a clinical trial for contact lenses implies they are qualified eye care professionals (e.g., optometrists, ophthalmologists) capable of conducting such assessments, measuring visual acuity, and interpreting slit lamp findings.

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

• The document does not specify an adjudication method for the test set. Findings and symptoms were "reported by the investigators at each visit." It appears the assessments were made by the two investigators, but there's no mention of a consensus or arbitration process if their findings differed.

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, an MRMC comparative effectiveness study was not done. This study is a clinical trial assessing the safety and efficacy of a contact lens for daily wear, not an AI-assisted diagnostic device. The document does not mention any AI component or human reader assistance.

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

• No, a standalone (algorithm only) performance study was not done. The device in question is a contact lens, which is physically worn by humans, and its performance is assessed through clinical observations by human investigators. There is no algorithm involved.

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

• The ground truth for the safety and efficacy assessments was based on clinical observations and measurements by investigators, including:
  • Slit lamp findings (presence/absence and grade of conditions like edema, neovascularization, staining, injection, tarsal, etc.)
  • Patient-reported symptoms, problems, and complaints (lens awareness, handling, reading issues, dryness, torn lenses)
  • Visual acuity measurements
  • Wear time
  • Lens cleanliness scores (modified Rudko classification)
  • Adverse reaction reports.
• This can be categorized as expert clinical assessment and patient-reported outcomes data.

8. The sample size for the training set:

• The document describes a clinical trial for the new device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm. The clinical trial data (37 subjects) serves as the basis for demonstrating substantial equivalence.

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

• As there is no training set for a machine learning model, this question is not applicable. The clinical study's "ground truth" (as described in point 7) was established through the professional assessments and observations of the two clinical investigators during the 4-week trial.

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The Igel®56 (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.

The Igel® 56 (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: 14 - 2mm Chord diameter: Center thickness: Sphere: 0.09mm (at-3.00 D) variable optic zone Optic Zone: with power Base Curve: 8.60mm -0.50D to -8.00D (in Power : 0.25D steps): -8.50D -12.00D (in to 0.50D steps); +0.50D to +6.00D (in 0.25D steps) Chord diameter: 14 - 6mm Toric: 0.15mm Center thickness: 8.45mm Optic Zone: 8.70mm Base Curve: Sphere: Plano to -8.00 D (in 0.25 D steps) Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cvlinder: 80, 90, 100, 160, 170, 180, 10 Axis: & 20° The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-vinyl pyrrolidinone. The blue tinted lens also contains D&C Green #6. The apparent color of the visibility tint may decrease slowly following repeated disinfection, but this will not affect the safety or performance of the lenses. When fully hydrated, the lens is 56% water by weight.

The provided document describes the Igel® 56 (hefilcon C) Soft (hydrophilic) Contact Lens and its clinical evaluation for market clearance. The study aimed to demonstrate substantial equivalence to existing devices rather than meeting specific quantifiable performance benchmarks.

Here's an analysis of the acceptance criteria and study in the requested format:

Acceptance Criteria and Device Performance

The acceptance criteria for this device, as presented in the document, are primarily qualitative and focused on demonstrating clinical safety and efficacy comparable to already marketed predicate devices. Since this is a 510(k) submission, the primary goal is "substantial equivalence."

Study Information:

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

   • Test Set Sample Size: 37 subjects.
   • Data Provenance: Prospective clinical trial conducted in the US (implied by FDA submission and approval process). The study was initiated July 11, 1997, and completed August 19, 1997.

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

   • The document states "Two (2) investigators enrolled a total of 37 test subjects." It does not explicitly state their qualifications beyond being "investigators." In the context of a contact lens study, these would typically be optometrists or ophthalmologists. They would have performed the slit lamp examinations, assessed visual acuity, and recorded symptoms/complaints.

3. Adjudication method for the test set:

   • The document does not describe a formal adjudication method (like 2+1 or 3+1). The "investigators" collected and reported the data. It's implied that they themselves made the clinical judgments for slit lamp findings and efficacy measures.

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 study is for a medical device (contact lens), not an AI diagnostic tool, so this type of study is not applicable here.

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

   • No. This study evaluates a physical medical device (contact lens) with human wearers, not an algorithm.

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

   • The ground truth for the safety and efficacy outcomes was based on clinical observation and assessment by the investigators. This includes:
     • Slit lamp findings: Direct observation and grading by the investigators.
     • Symptoms, problems, and complaints: Subject self-report collected and categorized by investigators.
     • Visual Acuity: Measured by standard clinical methods (e.g., Snellen chart) by the investigators.
     • Lens Cleanliness: Evaluated by investigators using a "modified Rudko classification."
     • Adverse events: Reported by investigators based on monitoring subjects.

7. The sample size for the training set:

   • This being a medical device (contact lens) study, there wasn't a "training set" in the machine learning sense. The "training" for the device's design and manufacturing would have been part of its development process, which is not detailed as a separate data set for a clinical trial.

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

   • Not applicable as there was no "training set" for a machine learning model. The development of the contact lens material and design would have relied on material science, engineering principles, and pre-clinical testing, which are distinct from establishing ground truth for clinical outcomes in a learning algorithm.

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