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For use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 in eyes with astigmatism or irregular astigmatism up to 6.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

The SynergEves™ PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a combination rigid gas permeable contact lens 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 .
• . in the range of 0.25 to 6.00 diopters cylinder
• with center thickness from 0.18mm to 0.30mm .
• with base curves of 7.10mm to 9.60mm .
• with diameter of 14.50mm .
  The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material cleared under K051035 and K052675. There are no differences to the chemical composition, formulation, manufacturing process, packaging and 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), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™Hybrid 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 post surgical refractive errors and trauma: multi concentric zones in blue visibility tinted material. This device is equivalent to the SynergEyes™ A and M Hybrid Contact Lens is material design and composition, and the SoftPerm® hybrid RGP manufactured by Ciba Vision Corporation.
  The SynergEyes™ PS Hybrid Daily Wear Contact Lens center optical portion is a rigid gas permeable material of (paflulofon-D) polymer. TThe soft skirt is comprised of HEMA (hydroxyethylmethacrylate) of 27% water and 73% polymer.
  The junction between the rigid material and soft material is bound by a proprietary chemical bonding method.

Here's a breakdown of the acceptance criteria and study information for the SynergEyes™ PS Hybrid Contact Lens, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense of a medical device submission beyond showing substantial equivalence to predicates. However, it evaluates safety and efficacy by tracking specific outcomes. I'll frame the reported device performance against generally understood good outcomes for contact lenses.

• 20/20 or better: 20.0%
• 20/25 or better: 45.0%
• 20/30 or better: 68.8%
• 20/40 or better: 81.3%
  Discontinued Subjects:
• 20/20 or better: 8.6%
• 20/25 or better: 39.7%
• 20/30 or better: 53.4%
• 20/40 or better: 70.7%
  3 completed eyes and 8 discontinued eyes had VA decreases of >2 lines (expected in this population). |
  | Efficacy: Wearing Time | Acceptable daily wearing time for daily wear lenses (e.g., >8-10 hours). | Average daily wearing time: 10.6 hours per day for completed patients. |
  | Comfort | Low rates of discomfort/awareness leading to discontinuation. | Discontinuation due to poor comfort: 27.5% of discontinuations.
  Reported Symptoms (Completed Subjects):
• Discomfort and awareness: 28.4%
• Dryness and scratchiness: 23.4%
• Itchiness and burning: 9.3%
• Variable vision: 8.2%
  Symptoms decreased over time for completed eyes. |
  | Overall Performance | Satisfactory performance and safe/effective use for intended purpose. | "The SynergEyes™ PS Hybrid Contact Lens for Post Surgical refractive error and cases involving trauma provided satisfactory performance as expected... Overall, the lens performance demonstrated safe and effective use of the device for its intended use." It notes the higher than estimated discontinuation rate was anticipated given the challenging patient population. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set:
  • Subjects: 76 subjects were dispensed into the study.
  • Eyes: 80 eyes (from 44 completed subjects) reached study completion. The total number of eyes enrolled isn't explicitly stated but would be at least 76 (assuming one eye per subject) and up to 152. The "58 eyes" mentioned for discontinued subjects suggests that some subjects wore lenses in both eyes.
• Data Provenance: The study was a "three month clinical study," implying a prospective design within a controlled clinical environment (likely in the US, given the FDA submission). No specific country of origin is mentioned beyond the applicant's US address.

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

This is not applicable. The study is a clinical trial assessing the direct performance of the contact lens on patients. The "ground truth" is the actual patient experience and objective clinical measurements (visual acuity, adverse events) as documented by clinical investigators and optometrists/ophthalmologists involved in the study. There's no mention of independent experts establishing a "ground truth" for a diagnostic performance metric.

4. Adjudication Method for the Test Set

This is not applicable, as it's a clinical trial for a contact lens, not a diagnostic device requiring adjudicated interpretations of images or data. Clinical investigators and study coordinators would have managed data collection and reported outcomes.

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 type of study is typically performed for diagnostic imaging devices where multiple readers interpret cases to assess diagnostic accuracy and inter-reader variability. This document describes a clinical trial for a contact lens.

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

No, a standalone algorithm performance study was not done. This document describes a clinical trial for a physical medical device (contact lens) worn by human patients, inherently involving human interaction (wearing, fitting, clinical evaluation).

7. The Type of Ground Truth Used

The "ground truth" in this context is based on clinical observation, patient-reported outcomes, and objective ophthalmological measurements collected during the prospective clinical study. This includes:

• Measurement of visual acuity (Snellen VA).
• Documentation of adverse events.
• Patient-reported symptoms and complaints (comfort, dryness, variable vision).
• Measured wearing time.
• Clinical assessments by practitioners (e.g., corneal health).

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device submission. This device (contact lens) is a physical product, not an AI/ML-based algorithm that requires a "training set" in the computational sense. The document describes a clinical study to evaluate the device's performance, not to develop or train an algorithm.

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

This information is not provided and is not applicable, as there is no "training set" for an AI/ML algorithm.

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