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The Boston ES® (enflufocon A) and Boston EO® (enflufocon B), Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased 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 (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased 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 (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

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 Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Contact Lenses (Scleral) for daily wear 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, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Scleral Lens designs for daily wear are also indicated for therapeutic use in eyes with ocular surface disease (e.g. 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, paralytic) 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 Boston Scleral Lenses may concurrently provide correction of refractive error.

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

Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from the currently marketed contact lens materials: enflufocon A, enflufocon B, and hexafocon B. Non-proprietary names were assigned by the United States Adopted Names Council (USAN). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid for locating the lenses may be available with an ultraviolet absorber.

The Boston ES® (enflufocon A), Boston EO® (enflufocon B), Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

The provided document is a 510(k) Premarket Notification for Bausch & Lomb's Boston ES®, Boston EO®, Boston XO®, and Boston XO2® Rigid Gas Permeable Contact Lenses with a new Tangible™ Hydra-PEG surface coating. This document details the company's claim of substantial equivalence to previously cleared predicate devices, rather than presenting a study for a novel AI/software as a medical device (SaMD).

Therefore, the information requested for acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for a device proving AI/software performance is not present in this document.

This submission focuses on demonstrating the safety and effectiveness of a modified contact lens product by comparing its technological characteristics and performance (primarily wettability and biocompatibility) to already cleared devices. The "performance data" sections refer to non-clinical (toxicology, biocompatibility, stability) and clinical (based on predicate device history) testing relevant to contact lenses, not AI model performance.

The only "acceptance criteria" explicitly mentioned and met are related to quality control for the contact lenses:

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Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed 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 lenses may be disinfected using a chemical disinfection system only.

Boston XO (hexafocon A) is a rigid gas permeable material, composed of siloxanyl fluoromethacrylate copolymer available with or without an ultraviolet absorber.

The Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) are rigid gas permeable contact lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer available with or without an ultraviolet absorber.

Boston XO, Boston EO, and Boston ES Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Additionally, these lenses may be prescribed for non-diseased eyes requiring a rigid contact lens for managing irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery (e.g., LASIK). Disinfection must be done using a chemical disinfection system only.

The safety and efficacy of these devices were established in prior 510(k) clearances (K000795, K013762, and K053124). For the current submission (K071043), the primary change was the addition of a UV blocker to the BOSTON XO material. Preclinical testing, as required by the "Pre-Market Notification Guidance for Daily Wear Contact Lenses, May 12, 1994," demonstrated the safety of this change. Since BOSTON EO and BOSTON ES already incorporate the same UV blocker, clinical studies were deemed unnecessary.

A table of acceptance criteria and reported device performance cannot be extracted as the provided text refers to "preclinical testing" for the UV blocker addition but does not detail specific acceptance criteria or performance metrics in a tabular format for this aspect, nor does it provide new clinical study data. The original clearances relied on historical data which is not provided in detail.

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

Specific acceptance criteria and device performance metrics, particularly for the addition of the UV blocker, are not provided in the document in a comparative table format. The submission primarily relies on the safety and efficacy established in previous 510(k) clearances and states that preclinical testing for the UV blocker was performed as required by guidance.

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

• Sample size: Not applicable for a new clinical test set. The submission states that "Clinical studies for the BOSTON XO... materials have been deemed as not necessary."
• Data provenance: Not applicable, as no new clinical studies were conducted for this 510(k) submission. The safety data for the UV blocker was generated through preclinical testing, but the specifics (e.g., country of origin, retrospective/prospective) are not detailed.

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 clinical studies were conducted and thus no expert-established ground truth for a new test set was required.

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

Not applicable, as no new clinical studies were conducted.

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, as this device is a contact lens and not an AI-assisted diagnostic tool.

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

Not applicable, as this device is a contact lens and not an algorithm.

7. The type of ground truth used:

For the original safety and efficacy of the contact lenses (from the predicate devices), the ground truth would have been based on clinical examinations by ophthalmologists/optometrists assessing visual acuity, ocular health, comfort, and adverse events. For the current submission, the ground truth for the safety of the UV blocker was established through preclinical testing (e.g., biocompatibility, toxicology), as evidenced by the mention of "preclinical testing as required in current Pre-Market Notification Guidance for Daily Wear Contact Lenses, May 12, 1994."

8. The sample size for the training set:

Not applicable for this context, as this is a contact lens approval, not an AI model requiring a training set.

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

Not applicable for this context.

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