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The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise nondiseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment, and the saline bath provided by scleral lens designs.

The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Siögren's syndrome, dry eve syndrome and Filamentary Kerattis, 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, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.

Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distorion 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, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error.

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 BostonSight® Specialty Lenses for daily wear are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A. The lenses fabricated from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A are available with or without Tangible® Hydra-PEG coating. The lenses fabricated from oprifocon A are not available with Tangible® Hydra-PEG. The lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. When shipped "wet", the lenses are packaged non-sterile in Boston SIMPLUS® Multi-Action Solution.

The provided document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the BostonSight® Specialty Lenses to existing predicate devices. It does not present a study proving the device meets specific acceptance criteria based on performance data. Instead, it relies on the predicate pathway, meaning the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market.

Therefore, many of the requested elements for a study proving the device meets acceptance criteria (such as sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of regulatory submission.

However, based on the information provided, here's what can be inferred or stated regarding "acceptance criteria" through the lens of substantial equivalence:

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

The "acceptance criteria" in this context are primarily the material properties and physical parameters that establish similarity to predicate devices already cleared by the FDA. The performance is assessed by demonstrating these properties are within acceptable ranges, consistent with the predicates.

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

• Sample Size: Not applicable. This submission relies on "Non-Clinical Studies" and "Clinical Studies" sections where it explicitly states that the safety and effectiveness have been "addressed by reference to previous 510(k) clearances." No new specific test set or clinical study data is presented for this particular submission.
• Data Provenance: The underlying data for the predicate devices would have come from their respective clearance processes. This document does not provide details on the provenance (country of origin, retrospective/prospective) of those original predicate studies.

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

• Not applicable as no new test set data is presented. The "ground truth" for the predicate pathway is essentially the FDA's prior determination of safety and effectiveness for the predicate devices.

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

• Not applicable as no new test set data is presented.

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-assisted device. Also, this is a substantial equivalence submission, not a new clinical trial comparing performance.

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

• Not applicable. This is a contact lens, not an algorithm.

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

• For this 510(k) submission, the "ground truth" is the established safety and effectiveness of the identified predicate devices, as previously determined by the FDA. The manufacturer is asserting that their new device is fundamentally similar in materials, design, and intended use, and therefore shares that established safety and effectiveness profile.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. This is a physical medical device.

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The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise nondiseased 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 Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eve 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, paralytic) that might benefit from the presence of an expanded tear reservor and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.

Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device (Rigid Gas Permeable Contact Lenses). It is not a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Therefore, I cannot extract the requested information about acceptance criteria, study sizes, expert ground truth establishment, MRMC studies, or training sets, as these concepts are not applicable to the type of device and submission described in the provided document. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for contact lenses based on material properties, manufacturing methods, and intended use.

The "PERFORMANCE DATA VII." section specifically mentions "Non-Clinical Studies" and "Clinical Studies". However, these sections refer to studies that were "addressed through previously cleared 510(k) premarket notifications" for the materials and existing uses of the contact lenses, rather than a new study demonstrating the performance of an AI-powered device.

If you have a document describing an AI/SaMD study, I would be happy to analyze it for the criteria you've outlined.

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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 Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact 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. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. 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 disinfected using a chemical disinfection system only. The lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.

The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Boston SIMPLUS Multi-Action Solution or Menicon Unique pH Multi-purpose solution.

The provided text describes the regulatory clearance of "The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses." However, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies is not found in the provided document.

The document explicitly states: "Clinical data is not necessary as the products, both RGP lenses and multi-purpose disinfection solutions are cleared for use as indicated."

Instead, the submission relies on:

• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a legally marketed predicate device (BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS Multi-Action Solution, K073184).
• Prior Clearances for Materials and Solutions: The gas permeable lens materials themselves (Acuity 100, Acuity 18, Acuity 85, Acuity 58) were previously cleared under separate 510(k)s. The multi-action solutions (BOSTON SIMPLUS and Menicon Unique pH) were also previously cleared. The current submission bundles these cleared components.
• Biocompatibility Testing: The materials have been tested and found to meet biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009).
• Solution Compatibility Studies: Previous 510(k)s for the individual RGP lens materials included solution compatibility studies demonstrating stable lens parameters when using the specified solutions.
• Microbiological Methods (Bioburden Studies): Bioburden studies (in accordance with ISO 11737-1) were conducted to monitor lens manufacturing. These were extended to evaluate wet storage and shipping for up to 30 days, finding "no CFUs were found at any test point during the 30-day period." This represents a specific "performance" aspect, but not in the context of clinical efficacy.
• Conformance to Standards: The quality system conforms to ISO Standard 13485 (2003).

In summary, the document argues that the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device and by referencing prior clearances and standard-based testing for its constituent materials and solutions, rather than presenting a new, dedicated study with specific performance acceptance criteria.

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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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