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The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (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 non-diseased eyes. The lens may be prescribed in spherical and aspheric 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 lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.

The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Boston SIMPLUS Multi-Action Solution or Menicon Unique pH Multi-purpose solution.

The provided text describes the regulatory clearance of "The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses." However, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies is not found in the provided document.

The document explicitly states: "Clinical data is not necessary as the products, both RGP lenses and multi-purpose disinfection solutions are cleared for use as indicated."

Instead, the submission relies on:

• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a legally marketed predicate device (BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS Multi-Action Solution, K073184).
• Prior Clearances for Materials and Solutions: The gas permeable lens materials themselves (Acuity 100, Acuity 18, Acuity 85, Acuity 58) were previously cleared under separate 510(k)s. The multi-action solutions (BOSTON SIMPLUS and Menicon Unique pH) were also previously cleared. The current submission bundles these cleared components.
• Biocompatibility Testing: The materials have been tested and found to meet biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009).
• Solution Compatibility Studies: Previous 510(k)s for the individual RGP lens materials included solution compatibility studies demonstrating stable lens parameters when using the specified solutions.
• Microbiological Methods (Bioburden Studies): Bioburden studies (in accordance with ISO 11737-1) were conducted to monitor lens manufacturing. These were extended to evaluate wet storage and shipping for up to 30 days, finding "no CFUs were found at any test point during the 30-day period." This represents a specific "performance" aspect, but not in the context of clinical efficacy.
• Conformance to Standards: The quality system conforms to ISO Standard 13485 (2003).

In summary, the document argues that the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device and by referencing prior clearances and standard-based testing for its constituent materials and solutions, rather than presenting a new, dedicated study with specific performance acceptance criteria.

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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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