Search Results

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.

Ask a specific question about this device

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism.

Eye care 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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.

The provided document is a 510(k) summary for a contact lens device, the Ampleye Scleral RGP Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results for device performance (e.g., accuracy, sensitivity, specificity, statistical significance with effect size) is not present for this contact lens device in this particular document.

Here's how to interpret the document in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria for a "device performance" study (e.g., accuracy metrics) are provided.
• Instead, the "performance" demonstrated is the ability to manufacture lenses to established finished product specifications within ANSI Z80.20-2016 tolerance and bioburden levels within acceptance criteria. These are manufacturing and safety standards, not clinical performance metrics in the sense of predictive or diagnostic accuracy.

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

• Test Set for Manufacturing Verification: The document states "Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters." It does not specify the sample size for this bench testing.
• Test Set for Bioburden Testing: "Bioburden testing conducted on rigid gas permeable lenses manufactured at Art Optical Contact Lens, Inc." The sample size for bioburden testing is not specified.
• Data Provenance: The testing was "conducted at Art Optical Contact Lens, Inc.", implying the data is generated internally by the manufacturer. It is "retrospective" in the sense that it's performed on manufactured lenses to meet a standard, but not a prospective clinical trial.

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

• Not applicable. This document describes manufacturing and safety testing, not a study where expert-established ground truth is used for performance evaluation (e.g., for an AI algorithm).

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

• Not applicable. This is not a study requiring expert adjudication of results.

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:

• No MRMC study was done. This is a contact lens device, not an AI-assisted diagnostic tool.

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

• Not applicable. This device does not involve an AI algorithm.

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

• For Manufacturing Verification: The "ground truth" or reference standard would be the ANSI Z80.20-2016 tolerance specifications.
• For Bioburden Testing: The "ground truth" or reference standard would be the established acceptance criteria of < 100 CFU per lens, likely derived from microbiological standards.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" for ground truth establishment.

Summary of the document's approach to "proving" substantial equivalence:

The document primarily relies on:

• Reference to previously cleared 510(k)s (K033594, K162005, and K052983) for the safety and effectiveness of the contact lens materials (roflufocon D, E, hexafocon A, paflufocon D). This means the materials themselves have already undergone review and met safety/effectiveness standards.
• Bench testing to confirm manufacturing capabilities to specific ANSI standards.
• Bioburden testing to ensure manufacturing hygiene and product safety.
• Comparison to predicate devices (BostonSight PD Prosthetic Device, K161461, and Custom Stable RGP Scleral Contact Lens, K170335) across various characteristics like materials, production method, classification, intended use, and physical properties to demonstrate that the new device does "not raise different questions of safety and effectiveness."

This approach is typical for contact lens 510(k) submissions, where the focus is on established material safety and equivalence of design/manufacturing to existing cleared devices, rather than a direct clinical performance study for accuracy or similar metrics.

Ask a specific question about this device