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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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The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The AVT NATURASOFT, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

Eyecare practitioners are to prescribe the lenses for quarterly 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 or hydrogen peroxide disinfection systems.

The AVT NATURASOFT Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material. (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

1. Table of acceptance criteria and reported device performance:

The document doesn't provide specific acceptance criteria values in a table. Instead, it states that the non-clinical testing demonstrates:

• Lenses supplied in glass vials are sterile for the indicated shelf-life.
• The packaging material and extracts are not toxic and not irritating.
• Lens physical and material properties are consistent with currently marketed lenses.

The reported device performance consists of its physical properties:

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

The document states that "A series of in vivo preclinical toxicology and biocompatibility tests were performed". However, it does not specify the sample size for these tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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

The document does not mention the use of experts for establishing ground truth for the test set, as no specific clinical outcome data is presented as a test set for expert review. The device's safety and effectiveness were established through non-clinical testing and substantial equivalence to a predicate device, rather than a clinical study requiring expert ground truth establishment in a traditional sense.

4. Adjudication method for the test set:

Not applicable, as no human-reviewed test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a contact lens, not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

Not applicable, as this is a medical device (contact lens) and not an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical testing involved established scientific protocols and GLP regulations. For the claim of substantial equivalence, the predicates' established safety and effectiveness data served as an indirect form of "ground truth".

8. The sample size for the training set:

Not applicable, as this is a contact lens and not a machine learning algorithm.

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

Not applicable, as this is a contact lens and not a machine learning algorithm.

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