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BostonSight Scleral daily wear contact lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and non aphakic persons. Also, the lenses may be prescribed in eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, keratoglobus, post-LASIK ectasia, or following penetrating keratoplasty or refractive surgery.

Furthermore, eves suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. BostonSight Scleral daily wear contact lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoclobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The BostonSight Scleral daily wear contact lenses are also indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), 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, that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Scleral daily wear contact lenses may concurrently provide correction of refractive error.

The lenses may be disinfected using a chemical disinfection (not heat) system only.

The BostonSight Scleral daily wear contact lenses are manufactured with a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The BostonSight Scleral daily wear contact lenses are lathe cut and fabricated from one of the following fluoro-silicone acrylate rigid gas permeable (RGP) lens materials:

• roflufocon D supplied by Contamac Ltd.
• roflufocon E supplied by Contamac Ltd.
• oprifocon A supplied by Bausch and Lomb, Inc.
• hexafocon B supplied by Bausch and Lomb, Inc.

The BostonSight Scleral daily wear contact lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight Scleral daily wear contact lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685.

When shipped "wet", The BostonSight Scleral daily wear contact lenses 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 Scleral daily wear contact lenses 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.

The provided document is a 510(k) summary for the BostonSight Scleral daily wear contact lenses. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the device meets specific acceptance criteria through a clinical study with a defined test set, ground truth, and expert adjudication in the manner typically seen for novel AI/ML-based medical devices.

Therefore, the information required to populate a table of acceptance criteria and the details of a study proving the device meets these criteria (including sample sizes, expert qualifications, and adjudication methods) are not present in this document. The document explicitly states that the purpose of the application is "to modify the labeling of previously FDA cleared RGP contact lenses/materials to include therapeutic indications for use." It further clarifies that non-clinical and clinical testing to demonstrate safety and effectiveness for the materials used "has been addressed in previous applications."

Here's a breakdown of why the requested information cannot be extracted from this document, and what is provided instead:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not present. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, not on meeting predefined performance criteria with quantitative results.

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

• Not present. There is no mention of a dedicated "test set" or a new clinical study conducted for this specific 510(k) submission. The document states that clinical performance data "has been previously addressed" in prior applications for the materials used.

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

• Not applicable/Not present. Since no new dedicated test set or clinical study is detailed, there's no mention of experts involved in establishing ground truth for such a study.

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

• Not applicable/Not present. No test set or corresponding adjudication process is described.

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 document describes a physical medical device (contact lenses), not an AI/ML-based device that would involve human readers or AI assistance.

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

• Not applicable. This is not an algorithm or software device.

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

• Not present. No new ground truth establishment is described for this submission. The equivalence relies on the established safety and performance of the materials and predicate devices.

8. The sample size for the training set:

• Not applicable/Not present. Contact lenses are physical devices, not AI models that require training sets.

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

• Not applicable/Not present. As above, no training set for an AI model is involved.

What the document does provide:

• Device Name: BostonSight Scleral
• Regulation Number: 21 CFR 886.5916 (Rigid Gas Permeable Contact Lens)
• Regulatory Class: Class II
• Indications for Use: (Detailed on pages 2 and 5-6)
  • Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic and non-aphakic persons.
  • Management of irregular corneal conditions (e.g., keratoconus, pellucid marginal degeneration, post-LASIK ectasia, post-keratoplasty/refractive surgery).
  • Therapeutic use for ocular surface disorders (e.g., GvHD, Sjögren's, dry eye, Filamentary Keratitis, limbal stem cell deficiency, disorders of the skin, neurotrophic keratitis, corneal exposure) benefiting from an expanded tear reservoir and protection.
• Predicate Devices:
  • "Boston XO® and Boston XO2® Rigid Gas Permeable Contact Lens" (K171404)
  • "OPTIMUM GP Daily Wear Contact Lens" (K180616)
  • "BostonSight PD Prosthetic Device" (K161461)
• Device Materials: roflufocon D, roflufocon E, oprifocon A, hexafocon B.
• Physical Properties: Refractive Index, Light Transmission, Specific Gravity, Oxygen Permeability (Dk), UV Light Blocking, Dynamic Receding Contact Angle (all listed with values for each material on page 5).
• Lens Parameters: Base Curve, Center Thickness, Diameter, Spherical Power (with ranges and tolerances on page 5).
• Basis for Clearance: Substantial equivalence to predicate devices based on intended use, indications for use, actions, classification, FDA material group, USAN materials, production method, and final packaging/shipping. The safety and effectiveness of the materials themselves were addressed in prior applications.

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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 BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eves 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 BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe cut and fabricated from one of the following hydrophobic rigid gas permeable (RGP) lens materials:

• roflufocon D supplied by Contamac Ltd.
• · roflufocon E supplied by Contamac Ltd.
• · oprifocon A supplied by Bausch and Lomb, Inc.
• · hexafocon B supplied by Bausch and Lomb. Inc.

The description of the roflufocon D. roflufocon E. oprifocon A. and hexafocon B RGP materials are addressed in K033594, K022128, and K071266 respectively.

The BostonSight IC Corneal & Scleral Lenses for daily wear may be prescribed in otherwise nondiseased 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 following refractive (e.g. LASIK) surgery.

The BostonSight IC Scleral Lens is a large diameter RGP lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera.

The BostonSight IC Corneal & Scleral Lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight IC Corneal & Scleral Lenses is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685.

When shipped "wet". The BostonSight IC Corneal & Scleral Lenses 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 IC Corneal & Scleral Lenses 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.

Here's an analysis of the provided text to extract information about acceptance criteria and study details.

Important Note: The provided text is a 510(k) Summary of Safety and Effectiveness for the BostonSight IC Corneal & Scleral Lenses. It claims substantial equivalence to predicate devices, meaning it relies heavily on the safety and effectiveness data of those previously cleared devices rather than extensive new studies directly evaluating the performance of the BostonSight IC lenses against specific acceptance criteria in a standalone or comparative effectiveness study. As such, many of the requested data points (like sample size for a test set, number of experts for ground truth, MRMC study details) are not present for the BostonSight IC lenses themselves, but rather for the predicate devices as referenced.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate Devices):

This section summarizes the "performance" of the BostonSight IC lenses by demonstrating their equivalence to predicate devices, particularly regarding physical properties, material composition, and intended use. The acceptance criteria, in this context, are implicitly met if the BostonSight IC lenses are shown to be equivalent to devices already deemed safe and effective by the FDA.

Study Details (Directly for BostonSight IC Corneal & Scleral Lenses):

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

   • Test Set Sample Size: Not explicitly stated as a separate clinical "test set" in the traditional sense for the BostonSight IC lenses. The submission focuses on bench testing and bioburden testing for the new device, and relies on the clinical data of the predicate devices.
   • Data Provenance: Bench testing and bioburden testing were conducted by Boston Foundation for Sight. The clinical safety and effectiveness data are primarily sourced from the predicate device clearances (K033594, K022128, K071266), which would have involved prospective clinical trials in their respective submissions. The country of origin for the predicate device studies is not specified in this document.

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

   • Not applicable for the bench testing or bioburden testing. For the clinical data referenced from predicate devices, this information is not provided in the 510(k) summary for the BostonSight IC lenses.

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

   • Not applicable for the bench testing or bioburden testing. For the clinical data referenced from predicate devices, this information is not provided.

4. 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 or imaging system.

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

   • Not applicable. This device is a contact lens, not an algorithm. Bench testing (e.g., manufacturing verification, bioburden) represents standalone performance of the physical product.

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

   • For the bench testing described (manufacturing verification, bioburden), the "ground truth" would be the established engineering specifications (e.g., ANSI Z80.20 tolerance for lens parameters) and microbial limits (e.g.,

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