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The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism.

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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) 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 Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.

The provided document is a 510(k) summary for a contact lens device, the Ampleye Scleral RGP Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results for device performance (e.g., accuracy, sensitivity, specificity, statistical significance with effect size) is not present for this contact lens device in this particular document.

Here's how to interpret the document in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria for a "device performance" study (e.g., accuracy metrics) are provided.
• Instead, the "performance" demonstrated is the ability to manufacture lenses to established finished product specifications within ANSI Z80.20-2016 tolerance and bioburden levels within acceptance criteria. These are manufacturing and safety standards, not clinical performance metrics in the sense of predictive or diagnostic accuracy.

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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 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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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.

1. precludes satisfactory spectacle lens correction
2. demonstrates significantly improved RGP contact lens corrected vision
3. incapable of wearing traditional corneal lenses
   Also for ocular surface disorders benefiting from physical protection and saline bath. |
   | Device Classification | Class II, Lenses, Rigid Gas Permeable, Daily Wear, HQD | Class II, Lenses, Rigid Gas Permeable, Daily Wear, HQD | Class II, Lenses, Rigid Gas Permeable, Daily Wear, HQD |
   | Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
   | FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone Acrylate |
   | Water Content |

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