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The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/ lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.

Eyecare 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 Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens 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 Custom Stable™ Rigid Gas Permeable (rofflufocon D, roflufocon E) Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D (supplied by Contamac Ltd.) or roflufocon E (supplied by Contamac Ltd.).

This document is a 510(k) premarket notification for a medical device, specifically a type of contact lens. It outlines the manufacturer's claim that their new device is substantially equivalent to a previously cleared predicate device. This type of FDA submission does not involve the rigorous clinical study design typically associated with proving a device meets specific acceptance criteria for AI/ML-based medical devices.

Therefore, I cannot extract the information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to this particular 510(k) submission for a physical contact lens.

This document focuses on demonstrating substantial equivalence based on comparable:

• Intended Use
• Indications for Use
• Technological Characteristics (materials, design, production method, physical properties)
• Performance Data (which here refers to non-clinical bench testing for manufacturing verification and reference to previously cleared 510(k)s for material clinical safety/effectiveness, not new clinical trials for this specific device).

The "performance data" sections (VII. PERFORMANCE DATA) specifically state that "Non-clinical testing to validate safety and effectiveness for finished contact lenses manufactured from roflufocon D and roflufocon E blanks has been addressed by reference to previously cleared 510(k) premarket notifications" and "Clinical performance data to validate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to previously cleared 510(k) premarket notifications." This confirms that no new standalone clinical studies were performed for this specific submission to define and meet new acceptance criteria.

In summary, the provided document does not contain the information needed to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth, or expert involvement, as it pertains to a traditional medical device (contact lens) seeking 510(k) clearance based on substantial equivalence, not an AI/ML-based medical device requiring such validation.

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The Valley Contax SV Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. Eyecare 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 Valley Contax AFM Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. 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 Valley Contax VK Gas Permeable Contact Lens (roflufocon E, tisilfocon A, hexafocon A, enflufocon A ) is indicated for daily wear for the corrective error in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may also be prescribed in otherwise non-diseased eyes that require a 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 Valley Contax SV, AFM, and VK Gas Permeable Contact Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) for daily wear are made-to-order with spherical or aspheric front surfaces, or a prism-ballasted toric front surface. The Valley Contax AFM Gas Permeable Contact Lens is made-to-order in a range of multifocal strengths and options. The Valley Contax VK Gas Permeable Contact Lens is intended for the management of irregular cornea conditions and is made-to-order in spheric, prism-ballasted toric, and multifocal front surface options. The lenses are lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A. The lenses are shipped "dry" in a polypropylene contact lens case.

The provided text describes a 510(k) premarket notification for "Valley Contax Single Vision (SV) Gas Permeable Contact Lens", "Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens", and "Valley Contax V Kone (VK) Gas Permeable Contact Lens." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel clinical study for the device's performance against specific acceptance criteria like an AI/ML product would.

As such, the information required to directly answer some of the questions (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not present in this document because it outlines a regulatory submission for contact lenses, not a study validating an AI/ML diagnostic tool.

However, based on the provided text, I can infer and state what is available regarding acceptance criteria and the "study" proving device performance in the context of a contact lens submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence):

For this type of device (contact lenses), acceptance criteria are not typically expressed as performance metrics like sensitivity/specificity but rather as meeting established physical properties, biocompatibility standards, and manufacturing tolerances that are considered safe and effective, similar to predicate devices. The "performance" is demonstrating these equivalencies.

Here's a table summarizing the physical properties that serve as de-facto performance metrics and acceptance criteria by demonstrating equivalence to previously cleared materials:

1. A table of acceptance criteria and the reported device performance:

See the table above. The acceptance criteria for contact lenses in a 510(k) submission are implicitly met by demonstrating that the device's characteristics (material properties, manufacturing tolerances) are equivalent to those of legally marketed predicate devices, which are deemed safe and effective. The "performance" is establishing this equivalence through non-clinical (bench) testing and reference to previous clearances.

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

• Test set sample size: Not explicitly stated. For bench testing of manufacturing parameters and bioburden, the sample size would be determined by internal quality control protocols, but it is not detailed in this regulatory summary.
• Data provenance: For material properties, it's "reported from predicate devices," meaning the data comes from previously cleared contact lenses using the same materials. For lens design/manufacturing verification and bioburden, the data is generated from testing performed by Valley Contax, Inc. The country of origin is not specified, but the submission is to the U.S. FDA. The testing is likely prospective (i.e., designed specifically for this submission) for the manufacturing verification and bioburden.

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

• This information is not applicable and not provided. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic devices, especially AI/ML. For contact lenses, the "truth" is whether the physical properties meet the established specifications and manufacturing tolerances.

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

• Not applicable and not provided. Adjudication methods are relevant for subjective interpretations (e.g., reading medical images) requiring multiple reviewers. For objective measurements like contact lens parameters and bioburden, standard quality control and laboratory procedures are followed, not adjudication.

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, this type of study was not done. MRMC studies are specific to evaluating the clinical performance of diagnostic medical devices, particularly those involving human interpretation of data (e.g., images) where AI tools might assist. This submission is for contact lenses, which are Class II physical devices.

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

• No, this is not applicable. This refers to the evaluation of AI/ML algorithms, which is not the device being cleared.

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

• Bench testing / Engineering specifications / Pre-established material properties from predicate devices. The "ground truth" for contact lens regulatory clearance revolves around objective measurements of physical, chemical, and biological properties, as well as adherence to manufacturing tolerances, all supported by existing standards and data from already-cleared, equivalent materials/devices. Clinical performance has been "addressed by reference to previously cleared 510(k) premarket notifications," implying that the safety and effectiveness of the materials in human eyes have already been established and accepted.

8. The sample size for the training set:

• Not applicable / Not provided. The concept of a "training set" applies to machine learning algorithms. This document describes the clearance of physical contact lenses.

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

• Not applicable. As explained above, there is no AI/ML training set for this device.

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The Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus. keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.

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 Custom Stable "11 Rigid Gas Permeable Scleral Contact Lens 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 Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluoro-silicone acrylate materials:

• · roflufocon D (supplied by Contamac Ltd.)
• · roflufocon E (supplied by Contamac Ltd.)

The device described is the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens. This document assesses its substantial equivalence to predicate devices rather than providing a study where the device meets acceptance criteria directly. However, based on the provided information, we can infer acceptance criteria from the performed tests and the comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Bench Testing: The document does not specify a separate "test set" sample size for bench testing. It indicates "All lenses were manufactured..." suggesting testing was conducted on a representative sample or a substantial portion of manufactured lenses to verify production capabilities. The provenance of this data is internal to Valley Contax, Inc. (manufacturer), and is prospective in relation to the manufacturing verification.
• Bioburden Testing: The sample size is not explicitly stated, but bioburden testing was conducted on "rigid gas permeable lenses manufactured at Valley Contax, Inc." The data provenance is internal to Valley Contax, Inc. and is prospective from the manufacturing process.
• Clinical Studies: The document refers to "a series of clinical case reports" for performance demonstration. The specific sample size for these case reports is not given, nor is the country of origin. These are likely retrospective case reports from practitioners fitting the lenses.
• Reference to Predicate Devices: For the bulk of safety and effectiveness, the device relies on existing data from predicate devices (K033594 - Optimum GP and K161461 - BostonSight PD). The sample sizes and provenance for those original approvals are not detailed in this document.

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

This document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on a de novo clinical trial with extensive ground truth establishment by external experts for a new device's performance.

• For the internal bench and bioburden testing, the "ground truth" is defined by established specifications (ANSI Z80.20 tolerance for manufacturing, less than 100 CFU for bioburden), which are likely set by industry standards and potentially internal quality assurance experts. No specific number or qualifications of "experts" are provided.
• For the "series of clinical case reports," the implicit "experts" are the eye care practitioners who prescribed and managed the patients. Their qualifications are not specified but would typically be optometrists or ophthalmologists.
• For the safety and effectiveness data derived from predicate devices, the "ground truth" and expert involvement would have been established during the approval process of those predicate devices, but this information is not included in the current document.

4. Adjudication Method for the Test Set:

• Bench Testing & Bioburden Testing: No explicit adjudication method is mentioned beyond compliance with pre-defined acceptance criteria (e.g., ANSI standards, CFU limits). This suggests direct measurement and comparison to thresholds rather than a multi-reader review process.
• Clinical Case Reports: Given they are "case reports," it's unlikely a formal adjudication method (like 2+1, 3+1 consensus) was used. Case reports typically document individual patient outcomes as observed and reported by a single practitioner or clinical team.
• Predicate Device Data: No information on adjudication methods for the predicate device studies.

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 comparative effectiveness study was mentioned, nor is there any indication of AI involvement in this device. This is a contact lens, not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No standalone (algorithm only) performance was evaluated, as this device is a physical contact lens and does not involve an algorithm.

7. The Type of Ground Truth Used:

• Bench Testing: Ground truth is based on engineering and manufacturing specifications (e.g., ANSI Z80.20 tolerance for lens parameters).
• Bioburden Testing: Ground truth is based on microbiological safety standards (CFU count).
• Clinical Case Reports: Ground truth is based on observed clinical outcomes and practitioner assessments of patient response to the lens (e.g., comfort, visual acuity, ocular health).
• Predicate Device Data: Ground truth would have been established during the original predicate approvals, likely through clinical trials and performance testing against objective measures and clinical endpoints.

8. The Sample Size for the Training Set:

This is a physical medical device (contact lens), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

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

Not applicable, as there is no training set for this device.

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