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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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