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The EyePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The EvePrintPRO (roflufocon D) Scleral GP Lens is a rigid gas permeable (RGP) lens designed from measurements of the ocular surface obtained by the EyePrint Impression Process. The vinyl polysiloxane (VPS) impression material used for the EyePrint Impression process is Panasil Initial Contact Light, with 510(k) clearance under K083701. The lenses are manufactured from the hydrophobic contact lens material (roflufocon D). When placed on the human cornea, the EvePrintPRO RGP lenses act as a refracting medium to focus light rays upon the retina.

The EyePrintPRO (roflufocon D) Scleral GP Lenses are available as lathe cut lenses manufactured from (roflufocon D) optical blanks, which incorporate a handling tint using the following FDA listed color additives: D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18.

In the EyePrintPRO (roflufocon D) Scleral GP Lenses with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2,2'-Dihydroxy-4,4'dimethoxybenzophenone.

The UV blocking for EyePrintPRO (roflufocon D) Scleral GP Lenses averages > 98% in the UVB range of 280nm - 315nm and 95% in the UVA range of 316 - 380nm.

The provided document describes the EyePrintPRO (roflufocon D) Scleral GP Lenses and presents information regarding its substantial equivalence to a predicate device, as well as some safety studies. However, it does not contain a comprehensive description of acceptance criteria for a device's performance that is then proven by a study. Instead, it presents limited safety evaluation criteria and their results.

Here's an analysis based on the available information, addressing what can be found and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, only one specific acceptance criterion and its corresponding result are clearly stated under the "Bioburden" section:

For the "Clinical Evaluation of EyePrint Impression Process," the criteria are less quantitative:

• Acceptance Criteria for NITBUT, Ocular Surface Redness, and Corneal Staining: No significant changes from baseline.
• Reported Device Performance: No significant changes from baseline were observed.

2. Sample Size Used for the Test Set and Data Provenance

• Bioburden Testing: The sample size for this test is not explicitly stated, only "rigid gas permeable lenses manufactured at the Advanced Vision Technologies facility." The provenance is internal (Advanced Vision Technologies).
• Clinical Evaluation of EyePrint Impression Process: The sample size was n = 8. The document does not specify the country of origin, but given the FDA submission, it is likely that the study was conducted in the US. It appears to be a prospective study as it involved evaluating subjects before and after a specific process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The document does not provide information on the number of experts or their qualifications for establishing ground truth for either the bioburden testing or the clinical evaluation. These are typically objective measurements rather than subjective expert interpretations.

4. Adjudication Method for the Test Set

• The document does not provide information on any adjudication methods used for the test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC comparative effectiveness study was not done, as this device (scleral GP lenses) is not typically evaluated in that manner. The information presented focuses on the physical properties and safety of the lens and the impression process, not on diagnostic accuracy involving multiple readers.

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

• N/A. This device is a physical medical device (contact lens) and not an AI algorithm. Therefore, the concept of a "standalone" algorithmic performance does not apply.

7. The Type of Ground Truth Used

• Bioburden Testing: The ground truth is established through microbiological culture methods, which provide a quantitative measure of colony-forming units.
• Clinical Evaluation of EyePrint Impression Process: The ground truth for NITBUT, ocular surface redness, and corneal staining would be objective clinical measurements and observations taken by eye care professionals.

8. The Sample Size for the Training Set

• N/A. This device is a physical medical device; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

• N/A. As stated above, there is no training set for this type of device.

Summary of Missing Information:

The request asks for details typically found in submissions for AI/ML-enabled diagnostic devices. The EyePrintPRO (roflufocon D) Scleral GP Lenses are a physical medical device (contact lenses). Therefore, many of the requested categories, such as MRMC studies, standalone algorithm performance, training sets, and ground truth establishment for AI models, are not applicable to this document. The document focuses on demonstrating the substantial equivalence of the new device to a predicate device based on material properties, manufacturing process, and safety data, as required for a 510(k) submission for this type of product.

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