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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 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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The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that:

1. precludes satisfactory spectacle lens correction
2. demonstrates significant improved rigid contact lens corrected vision
3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
   Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
   The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), 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 BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
   The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.

The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials:

• · roflufocon D (supplied by Contamac Ltd.)
• · roflufocon E (supplied by Contamac Ltd.)
• · oprifocon A (supplied by Bausch & Lomb, Inc.)
• · hexafocon B (supplied by Bausch & Lomb, Inc.)
  The BostonSight PD Prosthetic Device is designed to vault over the cornea and rest on the conjunctiva overlying the sclera, resulting in a tear reservoir between the back surface of the prosthetic device and the corneal surface. The tear reservoir masks optical distortions from an irregular corneal surface, and in combination with the device itself, protects the ocular surface from an adverse external environment, including but not limited to dysfunctional evelids and margins. The design parameters are customized to allow for tear exchange underneath the device.
  The BostonSight PD Prosthetic Device may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight PD Prosthetic Device is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685. When shipped "wet". The BostonSight PD Prosthetic Device manufactured from material supplied by Bausch & Lomb, inc. may be packaged and shipped in Boston Advance Comfort Formula Conditioning Solution (K974466) or Boston SIMPLUS Multi-Action solution (K024289). The BostonSight PD Prosthetic Device manufactured from material supplied by Contamac, Ltd. may be packaged and shipped "wet" in in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) K014162.

This document is a 510(k) Summary of Safety and Effectiveness for the BostonSight PD Prosthetic Device, a rigid gas permeable contact lens. As such, it does not contain a study or data proving the device meets acceptance criteria. Instead, it asserts substantial equivalence to predicate devices based on device characteristics, indications for use, and a reliance on prior clearances for materials and clinical performance of similar devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and statistical analyses cannot be extracted from this document. However, I can provide the available information:

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

The document does not explicitly state acceptance criteria in a quantitative manner for performance. Instead, it relies on substantial equivalence to predicate devices, implying that if the new device is sufficiently similar to the legally marketed predicate devices, it is considered safe and effective. The table below summarizes the comparison to predicate devices, which implicitly defines the "performance" as being comparable in key design and material aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a new study with a test set. Instead, it relies on prior clearances for predicate devices and materials. Therefore, no information on sample size for a test set or data provenance is available here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new study with a test set requiring ground truth establishment is described in this submission.

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

Not applicable.

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

Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.

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

Not applicable.

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

Not applicable, as no new study with a test set requiring ground truth establishment is described in this submission. The "ground truth" for contact lens performance and safety is typically established through clinical trials submitted for PMA devices or through extensive post-market experience for predicate devices.

8. The sample size for the training set

Not applicable, as no new clinical study with a training set is described.

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

Not applicable.

Summary based on the provided document:

The BostonSight PD Prosthetic Device gained 510(k) clearance by asserting substantial equivalence to existing legally marketed predicate devices. The "study" proving it meets acceptance criteria is primarily an analysis of its characteristics (materials, design, intended use) compared to previously cleared devices.

Specifically, the submission cross-references:

• Non-clinical studies and part of the clinical assessment: BostonSight IC Corneal & Scleral Lens (K153066).
• Therapeutic indications for use and device design: Boston® Scleral (itafluorofocon B) RGP Contact Lens (P860022/S40).
• Clinical studies for specific materials:
  • OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lenses (K033594)
  • Boston EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses (K022128)
  • Boston XO2 (hexafocon B) Daily Wear Contact Lens (K071266)

The document specifies that the new device does not raise different questions of safety and effectiveness than the identified predicate devices. Therefore, direct "acceptance criteria" and "device performance" in the context of a new, standalone study (as is often the case for AI/diagnostic devices) are not presented.

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Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal 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.

Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.

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 prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.

The lens may be disinfected using a chemical disinfection system only.

The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents.

The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

This 510(k) summary describes a rigid gas permeable contact lens, not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria, as well as several other elements of the prompt (such as number of experts, adjudication method, AI improvement, training set size, etc.), are not applicable to this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices.

However, based on the information provided, here's an attempt to answer the relevant aspects of your request regarding acceptance criteria and the "study" that proves the device meets them, interpreting "acceptance criteria" as meeting the chemical and physical properties of similar, already-approved devices, and "study" as the comparison of these properties:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices. The Menicon Z™ rigid gas permeable contact lens is considered to meet these criteria if its material properties are comparable to those of the predicate devices.

*Note: The Menicon Z™ Dk values are higher than the predicate examples, which is generally considered an advantage for contact lenses.

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

• Test Set Sample Size: Not applicable. This submission relies on material property comparisons and prior clearances, not a clinical test set in the traditional sense for an AI/ML device.
• Data Provenance: The data provided (material properties) are intrinsic to the device material and are likely derived from laboratory testing conducted by Menicon Co., Ltd. The document does not specify the country of origin of this specific material data or if it's retrospective/prospective outside of the general timeframe of the predicate device clearances.

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

Not applicable. Ground truth, in the context of an AI/ML device, is not established for this type of submission. The "ground truth" for material properties would be the measured values determined by standardized laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring expert 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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the measured physical and optical properties of the Menicon Z™ material, which are compared against those of already cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and thus there is no training set.

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

Not applicable. As there is no training set.

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