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The Envoy and Envoy Toric (epsifilcon A) Contact Lenses are indicated for daily wear by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less, the toric lens by persons with astigmatism of 9.00 diopters.

Envoy and Envoy Toric (epsifilcon A) Contact Lenses (clear and visibility tint with a molded back surface and a lathe cut front surface)

Based on the provided text, the document is a 510(k) clearance letter from the FDA for CooperVision's Envoy and Envoy Toric (epsifilcon A) Contact Lenses. This type of document declares "substantial equivalence" to a predicate device, rather than presenting a detailed study with acceptance criteria and device performance specific to novel claims or a new technology.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, and comparison to AI tools is not available within this FDA clearance letter. This document does not describe a performance study in the way you've outlined for a new medical device or software.

Here's why and what can be extracted:

• 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not require a Premarket Approval (PMA). The primary focus is on substantial equivalence, not necessarily on a de novo performance study with specific acceptance criteria as you might find for a novel device.
• Lack of Performance Study Details: The letter explicitly states, "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent..." It does not contain information about:
  • Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
  • A study comparing the device to a ground truth established by experts or pathology.
  • Sample sizes for test or training sets.
  • Expert qualifications or adjudication methods.
  • Any mention of AI, human-in-the-loop, or standalone algorithm performance.

Information that can be extracted related to the device and its intended use:

• Device Name: Envoy and Envoy Toric (epsifilcon A) Contact Lenses
• Manufacturer: CooperVision, Inc.
• Regulatory Class: II
• Product Code: 86 LPL
• Indications for Use:
  • Daily wear by non-aphakic persons with non-diseased eyes that are myopic or hyperopic.
  • Spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less.
  • Toric lenses by persons with astigmatism of 9.00 diopters.

In summary, virtually all the specific details you requested (points 1-9) about acceptance criteria and a detailed study proving performance are absent from this 510(k) clearance letter. This document confirms regulatory clearance based on substantial equivalence, not a detailed performance study as would be required for a novel or high-risk device or an AI/software as a medical device.

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