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The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.

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

The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilis contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appar somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

(Hioxifilcon B)

Refractive Index: 1.51 (dry) 1.42 (hydrated)
Light Transmission: greater than 94%
Surface Character: hydrophilic
Water Content: 49 %
Specific Gravity: 1.137 (hydrated)
Oxygen Permeability: 16.40 X 10 to the power of -11 (cm squared/sec) (ml O sub 2/ml x hPa @ 35 degrees C), (revised Fatt method)

This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This process does not involve extensive clinical trials with acceptance criteria, ground truth, or statistical analyses in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence based on material properties, intended use, and design similarity to existing predicate devices.

Here's what the document does provide, structured to address relevant aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the new device's properties to existing, legally marketed predicate devices to establish substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission is a 510(k), which relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a "test set" in the context of device performance evaluation against specific metrics. The "study" mentioned refers to the pre-clinical toxicology and clinical study data of the predicate device, BENZ-G 3X, which is leveraged to establish the safety profile of the new device.
• Data Provenance: The document states that the safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry) of the new device is "equivalent to the BENZ-G 3X." This implies that the safety and effectiveness data for the predicate device, BENZ-G 3X, is being referenced, but no details of that specific predicate study are provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No such "ground truth" establishment by experts for a specific test set is described or required for this type of 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is described as there isn't a "test set" in the context of a new performance study.

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:

• Not applicable. This device is a contact lens, not an AI-powered diagnostic or assistive technology for human readers.

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

• Not applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used:

• Not applicable. There is no "ground truth" in the context of a new clinical performance study for this 510(k). The basis for FDA clearance is substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as the predicate.

8. The sample size for the training set:

• Not applicable. No "training set" in the context of device development or performance evaluation is mentioned or required for this 510(k) submission.

9. How the ground truth for the training set was established:

• Not applicable.

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