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Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for spheres .
• with base curves of 4.0 mm to 11.50 mm ●
• with base curve chord of 6.0 mm to 6.5 mm ●
• with diameters of 7.0 to 21.0 mm

The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.

The provided text describes the regulatory clearance of a medical device, the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, based on substantial equivalence to predicate devices, rather than a direct study validating specific acceptance criteria against reported performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in the provided text in the format you requested, as the submission relies on demonstrating similarity to already approved devices.

However, I can extract information related to the performance data mentioned and the basis for determining substantial equivalence.

Here's an analysis based on the provided text, addressing your points as much as possible:

1. Table of acceptance criteria and the reported device performance:

The document states that the new device has been shown to be "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the new device's performance is comparable to the predicate devices across various characteristics. The "Comparison of Characteristics with the Predicate Device" table serves as the primary evidence for this.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data for clinical evaluation of the current device. The clearance is based on non-clinical data and substantial equivalence.
• Data Provenance: Not applicable in the context of clinical testing of this specific device for its performance against clinical acceptance criteria. The data presented is primarily non-clinical (biocompatibility, material testing, performance testing) to demonstrate substantial equivalence to previously cleared devices.

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

This information is not provided. The clearance is based on non-clinical testing and comparison to predicate devices, not on a clinical study requiring expert ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set requiring adjudication is described for this specific device.

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-assisted diagnostic tool, so an MRMC study is outside its scope.

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

Not applicable, as this is a medical device (contact lens), not a standalone algorithm.

7. The type of ground truth used:

• For the non-clinical tests (biocompatibility, performance testing), the "ground truth" would be established by validated laboratory testing methods and industry standards (e.g., ISO 10993-1:2018).
• For the overall device, the "ground truth" for its safety and effectiveness is primarily established by its substantial equivalence to predicate devices that have prior clearance based on their own safety and effectiveness data (which would include clinical studies for those predicate devices as referenced).

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

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

Not applicable.

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