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The Acuity 1800 (enflufocon 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 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 lens may be disinfected using a chemical disinfection system only.

The Acuity 18TM (enflufocon 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
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm ●
• . with diameter of 7.0 to 21.0 mm
  The lens material enflufocon 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 ES (AKA Boston 7-30) Material and Contact Lenses (enflufocon A) described K943177 and K053124.

The provided text describes a 510(k) premarket notification for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert review.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and adjudication methods for a study proving the device meets acceptance criteria is not explicitly available in this document in the typical sense of a diagnostic or AI-driven device.

Instead, the submission relies on the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a "Side-by-Side Comparison" of the new device (Acuity 18) and its predicate device (Boston ES (enflufocon A) RGP Lens). The "acceptance criteria" here are implicitly the characteristics and values of the predicate device, which the new device aims to match or be substantially equivalent to.

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

• No specific "test set" in the context of performance evaluation for an AI/diagnostic device is described. The comparison is based on the chemical, mechanical, and optical characteristics of the materials and designs.
• Data provenance: Not specified beyond the material properties, which would likely be derived from laboratory testing of the material itself.

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

• Not applicable. This submission does not involve clinical "ground truth" derived from expert consensus in the way a diagnostic device would. Substantial equivalence is established through material and design similarity, and non-clinical testing.

4. Adjudication method for the test set:

• Not applicable. No adjudication process is relevant for this type of submission.

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 is a contact lens submission, not an AI-assisted diagnostic device.

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

• Not applicable. This is a contact lens submission, not an algorithm. However, non-clinical tests were performed on the lens material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Laboratory-measured physical and chemical properties are the "truths" used for comparison. The biocompatibility requirements were met according to FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.

8. The sample size for the training set:

• Not applicable. This is a contact lens submission, not a machine learning model.

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

• Not applicable. This is a contact lens submission, not a machine learning model.

Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The study proving the device meets the implicit acceptance criteria (i.e., substantial equivalence to the predicate) is a non-clinical study involving chemical, mechanical, and optical characterization of the Acuity 18 (enflufocon A) RGP contact lens material and design.

• Methodology: The enantiomer A lens material manufactured by Acuity Polymers, Inc. was tested.
• Criteria for "acceptance": The new lens material and its characteristics were compared "side-by-side" with the predicate device (Boston ES (enflufocon A) Daily Wear Contact Lens). The "acceptance" was that the Acuity 18 material and lenses meet the biocompatibility requirements and that its chemical, mechanical, and optical characteristics are equivalent or sufficiently similar to the predicate lenses to demonstrate substantial equivalence.
• Results: The properties of the new lens (refractive index, oxygen permeability, specific gravity, hardness, modulus, and water content) were measured and compared. The submission concludes that "it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston ESTM (aka Boston 7-30) (enflufocon A) Daily Wear Contact Lens."
• Clinical Studies: "Clinical studies for the Acuity 18™ (enflufocon A) material have been deemed as not necessary in support of clearance of this premarket notification as no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material." This implies that the non-clinical data was sufficient to establish substantial equivalence based on existing guidance.

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The TYRO™-97 (hofocon A) and ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected only by using chemical disinfection

The TYRO™ 97 (hofocon A) Rigid Gas Permeable lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, [ 2-(2'-hydroxy-5'-methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

The ONSI™-56 (onsifocon A) Rigid Gas Permeable lens material, onsifocon A,is a polymer of trifluoroethyl methacrylate polymer with tris (trimethylsiloxy) methacryloxypropylsilane 3trimethoxysilylpropylmethacrylate methacrylic acid 1,3-bis(3methacryloxypropyl)tetrakis(trimethylsiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.

The blue tinted onsifocon A lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and Cl Solvent Yellow 18; the blue-UV lenses contain D&C Green No 6 and a UV absorber, { 2-(2'-hydroxy-5'methacryloxyethylphenyl)-2H-benzotriazole. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.

Here's a breakdown of the acceptance criteria and the study information for the TYRO™-97 and ONSI™-56 Rigid Gas Permeable Contact Lenses, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for these devices are based on demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by comparing several key physical properties of the new contact lens materials (hofocon A and onsifocon A) to those of the predicate devices (BOSTON ES, BOSTON EO, and BOSTON XO).

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

The document describes a 510(k) Premarket Notification process, which relies on demonstrating substantial equivalence to predicate devices rather than independent clinical trials for new materials per se.

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

   • The document does not explicitly mention a "test set" in the traditional sense of a clinical trial for evaluating the performance of the new devices against specific acceptance criteria. Instead, it relies on bench testing of the material properties to justify substantial equivalence.
   • Therefore, the sample sizes for the material property tests (e.g., number of lenses tested for oxygen permeability, hardness) are not specified in the provided text.
   • The data provenance for the reported performance values (e.g., Oxygen Permeability of 97 ANSI units for hofocon A) is from laboratory testing of the new materials (hofocon A and onsifocon A). The location or context of these labs is not given, nor is it specified if this was retrospective or prospective.

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

   • This question is not applicable in this context. The "ground truth" for the material properties is established through standardized physical and chemical testing methods (e.g., Fatt Method for oxygen permeability, sessile drop method for wetting angle, Shore Hardness for hardness). These are objective measurements, not subjective expert assessments.

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

   • This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert opinions, as the evaluation is based on objective material property measurements.

4. 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:

   • This is not applicable. This submission is for rigid gas permeable contact lenses, which are physical medical devices, not AI-powered diagnostic tools. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

   • This is not applicable. This refers to a medical device's algorithm performance, which is not relevant for contact lenses.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • As mentioned above, the "ground truth" for the performance claims (which are material properties) is established through standardized physical and chemical laboratory testing measurements. The document explicitly lists methods like "Fatt Method" for oxygen permeability and "sessile drop method" for wetting angle.

7. The sample size for the training set:

   • This is not applicable. This submission is for physical medical devices (contact lenses), not a machine learning algorithm that requires a training set.

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

   • This is not applicable for the same reason as point 7.

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