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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 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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