Search Results

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.

Ask a specific question about this device

The AIRPERM (siflufocon A) Rigid Gas Permeable Spherical, Aspherical, Toric and Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

THE AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR is an aspheric type multifocal which contains an aspherical (conicoid) curve on either the front or back surface. The lens is manufactured by the same method, i.e., lathing, as that used for the AIRPERM (siflufocon A) RIGID GAS PERMEABLE ASPHERIC CONTACT LENSES FOR DAILY WEAR except that the eccentricity of the lens periphery is made higher in order to impart a multifocal effect into the contact lens. The eccentricity for the aspheric single vision lenses varies from 0 to 0.8 and for the multifocal lenses varies from 0.9 to 1.5. All parameters of the AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR are described and measured in exactly the same way as those for the AIRPERM (siflufocon A) RIGID GAS PERMEABLE ASPHERIC CONTACT LENSES FOR DAILY WEAR. The lenses have the following parameters: Chord Diameter Approximately 6.5 to 11.5 mm, Center Thickness for Low Minus Lens: 0.05 to 0.30 mm, for Plus Lens: 0.10 to 0.70 mm, Base Curve 6.50 to 9.00 mm, Powers -20.00 to +12.00 Diopters, Add Powers +1.00 to + 3.00, Eccentricity 0.1 to 1.5. The physical properties of the lens are: Specific Gravity 1.25, Refractive Index 1.43 (589 nm at 25°), Light Transmittance Clear > 92% (380-780 nm), Tinted >88.0% (380-780 nm), Wetting Angle (CLMA Method) 24.0 ± 2, Water Content

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving such criteria.

The document describes the:

• AIRPERM (siflufocon A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR including its physical properties and parameters.
• INDICATIONS (USES) and CONTRAINDICATIONS (REASONS NOT TO USE) for the contact lenses.
• PRECAUTIONS related to the lenses.
• SELECTION OF PATIENTS for whom these lenses are suitable.
• FITTING PROCEDURE OUTLINE detailing steps for pre-fitting examination, initial lens power and diameter selection, and initial base curve selection.
• Adjunct Solutions used with the lenses.

Therefore, I cannot extract the requested information regarding acceptance criteria and a corresponding study from this text.

Ask a specific question about this device