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The Visionary Optics Scleral Contact Lens for daily wear is 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, Salzman'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 from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.

Eye care 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 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) 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 Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.

The provided FDA 510(k) summary (K233325) for the Visionary Optics Scleral Contact Lens describes non-clinical and clinical studies conducted to support the substantial equivalence claim. However, it does not provide specific acceptance criteria or detailed study results in the format requested. The document primarily focuses on demonstrating equivalence to predicate devices rather than providing a standalone performance validation for a novel device with explicit performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available within the provided text.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not present specific numerical acceptance criteria (e.g., "X% accuracy," "Y precision"). Instead, for non-clinical studies, it states that manufacturing tolerances were met and bioburden was "within the established acceptance criteria of less than 100 CFU per lens." For clinical studies, the "acceptance criteria" appear to be implied by the outcome: no serious adverse events and stable/improved patient conditions.

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

• Test set sample size: 33 patients (63 total eyes).
• Data provenance: Not explicitly stated, but the study involved "Nine (9) independent practitioners," suggesting a multi-center, prospective clinical evaluation. The document does not specify the country of origin of the data.

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

• Number of experts: Nine (9) independent practitioners.
• Qualifications of experts: Not explicitly stated other than "independent practitioners." Their specific specializations (e.g., ophthalmologists, optometrists, or subspecialties) or years of experience are not provided.

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

• Adjudication method: Not described. The text states that "The practitioners reviewed all patients therapeutically managed... and reported the outcome of each patient." There is no mention of an adjudication process among these practitioners for establishing a unified ground truth.

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

• MRMC comparative effectiveness study: No, this document pertains to a medical device (scleral contact lens), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.

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

• Standalone performance: No, this device is a physical contact lens, not an algorithm. The clinical performance inherently involves human fitting and patient use.

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

• Type of ground truth: The "ground truth" for the clinical study appears to be the observed clinical outcome reported by the independent practitioners, specifically: "no serious or significant adverse reactions reported" and "for all patients, the ocular condition(s) and vision remained stable or improved." This is a form of outcomes data based on clinical observation and assessment by practitioners.

8. The sample size for the training set

• Training set sample size: Not applicable and not mentioned. This is a medical device, not a machine learning model. The "training" described in the context of this submission refers to the historical data and previous 510(k) clearances that establish the safety and effectiveness of the materials used in the lens.

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

• Ground truth establishment for training set: Not applicable and not mentioned. As this is not an AI/ML device, the concept of a "training set ground truth" as you've framed it is not relevant. The safety and effectiveness of the materials (roflufocon D, roflufocon E, etc.) used in the device were established through "reference to previous 510(k) clearances" and "previous 510(k) clearances," implying that historical data and prior regulatory assessments for these materials served as the basis for their use in the current device.

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The Visionary Optics Scleral Contact Lens for daily wear is 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 from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.

Eye care 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 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) 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 Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon B, or tisilfocon A.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and device performance. The document is a 510(k) summary for a contact lens, primarily focusing on its substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or adjudication methods for performance evaluation.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No explicit Acceptance Criteria: The document mentions that lenses were manufactured to "established finished product specifications within the ANSI Z80.20 tolerance" for bench testing, and bioburden testing had an "established acceptance criteria of less than 100 CFU per lens." However, it does not provide a comprehensive table of acceptance criteria for the overall device performance as per your request (e.g., visual acuity, comfort, etc.).
• No detailed Device Performance Results: While it states that manufacturing verification testing demonstrated the ability to manufacture lenses "to a variety of prescribed parameters" and bioburden testing was "within the established acceptance criteria," it does not provide specific numerical results or a comparative performance table against a set of acceptance criteria.
• No information on Test Set Sample Size and Data Provenance: The document does not specify the sample size used for any performance testing, nor does it provide information about the country of origin or whether the data was retrospective or prospective.
• No information on Experts for Ground Truth: There is no mention of experts, their number, or qualifications used to establish ground truth for any testing described.
• No Adjudication Method: The document does not describe any adjudication methods used for a test set.
• No MRMC Comparative Effectiveness Study: The submission primarily relies on substantial equivalence to predicate devices and general claims of safety and effectiveness, not a multi-reader multi-case comparative effectiveness study with AI assistance.
• No Standalone Performance (AI-specific): This device is a contact lens, not an AI algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.
• No Ground Truth Type (for performance studies): Since detailed performance studies with ground truth are not presented, this information is not available. The "ground truth" for a contact lens would typically involve clinical measurements by optometrists/ophthalmologists, patient feedback, and objective physiological responses, but these are not quantified or described in the provided text.
• No Training Set Sample Size or Ground Truth Establishment for Training Set: As this is not an AI device, the concepts of training sets and their ground truth establishment are not applicable here.

The section under "VII. PERFORMANCE DATA" explicitly states:

• "Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A has been addressed by reference to previous 510(k) clearances."
• "Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances."

This indicates that extensive new performance studies were not conducted for this specific 510(k) clearance, but rather reliance on prior clearances for similar materials and designs. The only specific tests mentioned are:

• Bench Testing: Manufacturing verification to ensure lenses meet ANSI Z80.20 tolerance for established finished product specifications. No specific results table or acceptance criteria other than "within the ANSI Z80.20 tolerance" are provided.
• Bioburden Testing: Demonstrated "colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens."

Therefore, I cannot extract the level of detail you are requesting from this document.

Ask a specific question about this device

The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that leads 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 from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graftversus-Host disease. Sjogren's syndrome, dry eve syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster. Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, hyperopia, astigmatism or presbyopia.

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 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) 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 Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or hexafocon B.

The provided document is a 510(k) summary for a medical device, the Visionary Optics Scleral Contact Lens. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than conducting new clinical trials to prove safety and effectiveness from scratch. Therefore, the information typically requested about acceptance criteria and detailed study designs for a new device's performance may not be fully present in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a new clinical study. Instead, it relies on demonstrating that the physical and material properties of the Visionary Optics Scleral Contact Lens are within established specifications and comparable to predicate devices. The "reported device performance" is largely inferred from meeting these specifications and the substantial equivalence claim.

Note: The acceptance criteria for many of the physical and material properties are implicit in the comparison to the predicate devices and the fact that the new device states these values. The document asserts that the new device "demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim."

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" sample size for a clinical trial involving human subjects. The non-clinical studies mention "All lenses" for manufacturing verification and "rigid gas permeable lenses manufactured at Visionary Optics LLC" for bioburden testing, implying a representative sample from their production. For clinical evidence, it relies on "a series of clinical case reports" and references previous 510(k) clearances (K033594, K071043, and K071266) for the materials used.
• Data Provenance:
  • Non-Clinical (Bench & Bioburden): From Visionary Optics LLC's own manufacturing and testing facility. This is prospective for the purpose of this submission (i.e., new tests performed for this device).
  • Clinical: Primarily by reference to previous 510(k) submissions for the lens materials. The "series of clinical case reports" would typically be retrospective, gathering outcomes from actual use of the device. No country of origin is explicitly stated for these case reports or the referenced 510(k) clinical data, but for FDA submissions, it's generally assumed to be U.S. or internationally recognized standards.

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

This information is not applicable or provided in the context of this 510(k) submission. This is not a study requiring expert-derived ground truth as would be found in a diagnostic AI study. The "ground truth" for the non-clinical tests would be the measured physical properties and bioburden counts. For the clinical case reports, the "ground truth" would be the patient outcomes as documented by the eye care practitioners who prescribed the lenses.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described for the non-clinical tests or the clinical case reports in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging devices involving human readers. For contact lenses, the evaluation focuses on physical parameters, material safety, and clinical performance (patient outcomes), not on the interpretation of images by multiple readers. The submission relies on "substantial equivalence" to predicate devices and existing data for the materials.

6. Standalone Performance (Algorithm Only)

Not applicable. This device is a physical contact lens, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. Type of Ground Truth Used

• Non-Clinical (Bench Testing): Established engineering specifications and measurements (e.g., dimensions, powers).
• Non-Clinical (Bioburden Testing): Microbiological culture results.
• Clinical (Relevant to Referenced 510(k)s and Case Reports): Patient physiological responses, visual acuity, comfort, and other clinical outcomes observed by eye care practitioners.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are established based on validated engineering and material science principles.

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

Not applicable, as no training set for an algorithm is involved.

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