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SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

The SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a corneal optic portion surrounded by a soft hydrophilic skirt that straddles the limbus of the eye:

• in the power range of -20.00 to +20.00 diopters for sphere, -0.50 to -6.00D cylinder.
• with center thickness from 0.18mm to 0.30mm.
• with base curves of 5.50mm to 7.70mm.
• with diameter of 14.50mm.
  The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material. There are no differences to the chemical composition, formulation, or sterilization as described in the referenced 510(k).
  This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic Copolymer (hem-iberfilcon A), by means of e-beam sterilization. When placed on the eye, the Contact Lens acts as a refracting medium to focus light rays onto the retina. The device is available as a lathe cut contact lens in the following design for Keratoconus: In A and M Hybrid Contact Lens is material design and composition, and the visibility tinted material. This device is equivalent to the SynergEyes - A and M Hybrid Contact Lens for Keratoconus and manufactured by Ciba Vision Corporation.
  The SynergEyes™ KC Hybrid Daily Wear Contact Lens is a rigid gas permeable material of (paflulofon-D) rigid gas permeable polymer. The soft skirt is comprised of HEMA (hydroxyethylmethacrylate) of 27% water and 73% polymer.
  The junction between the rigid material is bound by a proprietary chemical bonding method.

The provided text describes the SynergEyes™ KC Hybrid Contact Lens for Keratoconus and its clinical study. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state pre-defined acceptance criteria with specific numerical targets for efficacy or safety endpoints (e.g., "visual acuity must improve by X lines for Y% of subjects"). Instead, the conclusion states that the device "provided satisfactory performance as expected" and "demonstrated safe and effective use of the device for its intended use" based on the observed outcomes.

Therefore, the "acceptance criteria" can be inferred from the study's primary outcomes for safety and effectiveness, and the "reported device performance" are the results achieved in these areas.

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

• Sample Size: A total of 62 subjects were dispensed lenses and evaluated. 44 subjects (71%) completed the study, and 18 subjects (29%) were discontinued.
• Data Provenance: The study was a "prospective, multi-site, open label study" conducted in the United States, enrolling subjects at 12 sites. The data is prospective.

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

The document does not mention the use of external experts to establish "ground truth" in the way it might for an AI diagnostic device. For this contact lens study, the assessment of safety and effectiveness relied on:

• Visual acuity measurements.
• Slit lamp (biomicroscopic) examinations performed by the clinical investigators at each site.
• Patient-reported symptoms, problems, and complaints.
• Adverse event reporting.

The qualifications of the clinicians involved (e.g., ophthalmologists, optometrists) are not explicitly stated, beyond the fact that the contact person is an Optometrist (Richard Lippman, OD FAAO VP Ophthalmic Regulatory Products).

4. Adjudication Method for the Test Set

There is no mention of an adjudication method (like 2+1 or 3+1 consensus) for the clinical data. Clinical assessments (visual acuity, slit lamp, etc.) and adverse events were likely recorded by the site investigators and then aggregated and analyzed by the study sponsor.

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 was not an MRMC comparative effectiveness study involving AI. It was a clinical study evaluating the safety and effectiveness of a contact lens in human subjects.

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

This was a clinical study of a medical device (contact lens) and not an AI algorithm. Therefore, no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the direct clinical observations and measurements of patient health, visual performance, and comfort. This includes:

• Clinical Measurements: Visual acuity, slit lamp examination findings (staining, injection, edema, neovascularization).
• Patient-Reported Outcomes: Discomfort/awareness, dryness/scratchiness, blurred vision, itching/burning, and reasons for discontinuation (e.g., poor comfort, poor vision, loss of interest).
• Adverse Event Reporting: Documented adverse events and their resolution.

8. The Sample Size for the Training Set

There is no mention of a "training set" as this was a clinical study for a physical medical device, not an AI model requiring machine learning training data.

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

Not applicable, as this was not an AI/machine learning study.

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