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The Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lons for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

The Acuity 100™ (hexafocon 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 sphere 0
• with base curves of 4.0 mm to 11.50 mm 0
• 0 with base curve chord of 6.0 mm to 6.5 mm
• with diameter of 7.0 to 21.0 mm 0
  The lens material (hexafocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material. The material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO Material and Contact Lenses (hexafocon A) described in K071043.

The provided document is a 510(k) Premarket Notification for the Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens. This type of submission establishes substantial equivalence to a legally marketed predicate device rather than independently proving performance against acceptance criteria using clinical studies.

Therefore, the main "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to the predicate device, the Boston XO (hexafocon A) Daily Wear Contact Lens (K071043), based on material properties, design, and intended use as per the FDA Daily Wear Contact Lens Guidance Document, May 1994.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, "acceptance criteria" are implicitly met by demonstrating similarity to the predicate device. The performance is reported as the characteristics of the new device compared to the predicate device.

The "acceptance criteria" here are essentially that the new device's characteristics and performance are comparable to or within acceptable variations of the predicate device's established characteristics.

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

Test Set: No specific "test set" from a clinical study is mentioned. The assessment is based on non-clinical (bench) testing of the hexafocon A lens material and a comparison of its properties to the predicate.
Data Provenance: The document does not specify the country of origin for the non-clinical testing data. It does not explicitly state if the data is retrospective or prospective, but it implies the testing was done for the purpose of this submission (prospective testing for biocompatibility, chemical/mechanical/optical characteristics).

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

Not applicable. No ground truth established by experts for a test set is mentioned, as clinical studies were not deemed necessary. The evaluation was based on material science and engineering principles, comparing the new lens's properties to a known predicate.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication by experts is described.

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 tool, so MRMC studies and AI assistance are not relevant.

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

Not applicable. This refers to AI algorithms, which are not relevant to this device.

7. The type of ground truth used

The "ground truth" for the comparison of the new device to the predicate is the established properties and performance of the legally marketed predicate device (Boston XO Contacts, K071043), as well as biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009). These are based on scientific standards and previous regulatory clearances.

8. The sample size for the training set

Not applicable. This refers to AI algorithms, which are not relevant to this device.

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

Not applicable. This refers to AI algorithms, which are not relevant to this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is primarily a non-clinical comparative study.

• Study Type: Non-clinical (bench) testing and comparative analysis.
• Purpose: To demonstrate substantial equivalence of the Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens to the predicate device, the Boston XO (hexafocon A) Daily Wear Contact Lens (K071043).
• Methodology:
  • Biocompatibility Testing: The hexafocon A lens material manufactured by Acuity Polymers, Inc. was tested and found to meet the biocompatibility requirements of the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009) for a surface device, limited contact.
  • Chemical, Mechanical, and Optical Characteristics Testing: The new lens underwent testing to determine its chemical, mechanical, and optical properties (e.g., refractive index, oxygen permeability, specific gravity, hardness, modulus, water content).
  • Side-by-Side Comparison: The results of the new lens's testing were directly compared to the known characteristics and "Indications for Use" of the predicate device.
• Conclusion: The properties of the new material and the lens made thereof were found to be substantially equivalent to the predicate lens and material, meeting the requirements for a daily wear rigid contact lens. Clinical studies were not deemed necessary since no new or additional questions of safety or effectiveness were raised by the preclinical testing and evaluation.

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