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The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Wetting Angle (Dynamic contact receding angle), Specific Gravity, Oxygen Permeability (Dk) ISO/FATT Method, Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D. The lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Secondary Curves, Peripheral Curves, Multifocal Power.

The provided document is a 510(k) Premarket Notification for the iSee Daily Wear Orthokeratology Contact Lenses. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to an already marketed predicate device (OPTIMUM GP OK Daily Wear Contact Lens). The basis for this equivalence is a comparison of technological characteristics, materials, production methods, and intended use.

Here's a breakdown of why this document doesn't provide the requested AI/ML device study information:

• Non-Clinical and Clinical Studies (Section VII): This section explicitly states:
  • "The non-clinical performance data to establish the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to the predicate devices."
  • "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E have been addressed in previous applications."

This means that C&E GP Specialists, Inc. did not conduct new independent studies for this 510(k) submission. They are relying on existing data for the materials and the predicate device to establish safety and effectiveness.

Therefore, I cannot provide the requested information from this document for an AI/ML device since it is for a contact lens and references prior data rather than presenting a new study.

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The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6. C.I. Solvent yellow No. 18. and FD&C Red No. 17.

In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm.

The provided text is a 510(k) summary for the OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens. It does not describe a study that uses acceptance criteria in the manner typically associated with AI/ML device performance evaluations. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed clinical or technical study with specific performance metrics and acceptance thresholds for a novel device function.

Therefore, many of the requested fields cannot be directly extracted or are not applicable from this type of regulatory document.

However, I can extract information related to product specifications and a comparison to predicate devices, which serve a similar purpose in demonstrating that the new device is "as good as" existing, cleared devices.

Here's an attempt to answer the questions based on the provided text, while noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the context of a statistical study with performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic test. Instead, it demonstrates substantial equivalence by comparing the physical and chemical properties and indications for use of the proposed device to legally marketed predicate devices. The "performance" here is that its characteristics are similar enough to existing devices to not raise new questions of safety and effectiveness.

Here's a table comparing key characteristics of the subject device with its predicates, as presented in the document:

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The CONTEX OK™ (siflufocon A) Rigid Gas Permeable Contact Lens for Orthokeratology is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 3.00 diopters. The lens may be disinfected using a chemical disinfection system only. Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued on a prescribed wearing schedule.

The CONTEX OK™ (orthokeratology) contact lens is a rigid gas permeable contact lens in a reverse geometry design. The lens material siflufocon A, is a fluoro silicone acrylate polymer which contains D & C Green #6 as a color additive. The CONTEX OK™ (orthokeratology) contact lens has the following dimensions: Chord Diameter................Approximately 6.5 to 13.0 mm Center Thickness for Low Minus Lens..................................0.10 to 0.30 mm for Plus Lens:........................................0.20 to 0.70 mm Base Curve........................................6.50 to 11.00 mm Secondary Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve Peripheral Curves........................ 0.1 to 2 mm. Flatter or Steeper than Base Curve Powers........................................-10.00 to +5.00 Diopters Aspheric Lens Eccentricity ................................................................................................................................................... (Oblate, Prolate or Tangent Conic) The physical properties of the lens are: Refractive Index...... 1.43 (Nd at 25°) Light Transmittance... > 92.5% (370-760 nm) Wetting Angle ... 24.0 (Contact Receding Angle) Specific Gravity.... 1.25 Hardness.... 82 Water Content...

This document describes an orthokeratology contact lens (CONTEX OK™) intended for the temporary reduction of myopia. Below is an analysis of its acceptance criteria and the study performed.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria are implied through the intended use and the clinical study results, as no explicit numerical acceptance targets are stated. The device is shown to be effective if it can achieve a temporary reduction in myopic refractive error.

• Average reduction: 1.69 diopters (range 0.25 to 4.25 D).
• 32% of eyes had 0.25-1.00 D reduction.
• 32% of eyes had 1.25-2.00 D reduction.
• 23% of eyes had 2.25-3.00 D reduction.
• 9% of eyes had 3.25-4.00 D reduction.
• 1% of eyes had 4.25 D reduction.
• 106 out of 110 eyes showed some reduction.
• Limit for full reduction to emmetropia: -3.50 diopters.
• For initial myopia >3.75D, average reduction was 2.75D. |
  | Visual Acuity Improvement: | Uncorrected Visual Acuity (Final Visit):
• 39% of eyes achieved 20/20 or better.
• 71% of eyes achieved 20/40 or better.
  Visual Acuity with contact lenses (Final Visit):
• 99 eyes (90%) 20/20 or better
• 109 eyes (99%) 20/40 or better
• 1 eye 20/70.
• Some eyes experienced 1-3 line drops in visual acuity, attributed to residual astigmatism. |
  | Corneal Flattening (Keratometry): | Keratometry:
• 89% of eye meridians flattened.
• Average flattening: 1.17 diopters.
• Greatest flattening: 4.13 diopters.
• Corneal astigmatism change: 8% no change, 32% decrease 1D. |

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

• Sample Size (Test Set): 138 eyes were initially enrolled, with 136 eyes dispensed contact lenses. 110 eyes completed a minimum of three months of contact lens wear. The performance data is generally reported on these 110 eyes that completed the study.
• Data Provenance: The document does not explicitly state the country of origin. It describes a "Preclinical Studies: Described in the original 510 (k) submission K941883" and "Clinical Studies" for the K9736097 submission, suggesting the data is part of the regulatory submission for the United States. The study appears to be prospective clinical trial, observing patients over a three-month period.

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

The document does not provide information on the number or qualifications of experts used to establish a ground truth for the test set. Clinical studies concerning contact lenses typically rely on measurements taken by trained optometrists or ophthalmologists, but this information is not detailed here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set data. Clinical measurements were likely taken by the participating clinicians.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the safety and effectiveness of a medical device (contact lens) in patients, rather than an AI-assisted diagnostic tool.

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. This product is a physical medical device (contact lens), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the contact lens's performance was based on direct clinical measurements and observations of the patients using the device, including:

• Refractive Power: Measured reduction in myopic refractive error (diopters).
• Visual Acuity: Measured visual acuity (e.g., 20/20, 20/40).
• Keratometry: Measured changes in corneal flattening (diopters).
• Slit-Lamp Findings: Direct observation of ocular health.
• Adverse Events/Symptoms/Complaints: Patient reported and clinically observed adverse effects.

8. The Sample Size for the Training Set

This product is a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical study enrolled 138 eyes, with 110 eyes completing three months of wear. This would be considered the sample for evaluating the device's performance.

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

As this is not an AI algorithm, there is no "training set" or "ground truth" for a training set in the machine learning sense. The clinical data collected from the 110 eyes that completed the study served as the evidence for safety and effectiveness.

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