Search Results

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.

Ask a specific question about this device

The Boston Sight PD Prosthetic Device for daily wear is indicated for the management of a distorted corneal surface that:

1. precludes satisfactory spectacle lens correction
2. demonstrates significant improved rigid contact lens corrected vision
3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
   Causes of corneal distortion include corneal degeneration (e.g. keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g. lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
   The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), 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 distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
   The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.

The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cut from one of the following fluoro-silicone acrylate materials:

• · roflufocon D (supplied by Contamac Ltd.)
• · roflufocon E (supplied by Contamac Ltd.)
• · oprifocon A (supplied by Bausch & Lomb, Inc.)
• · hexafocon B (supplied by Bausch & Lomb, Inc.)
  The BostonSight PD Prosthetic Device is designed to vault over the cornea and rest on the conjunctiva overlying the sclera, resulting in a tear reservoir between the back surface of the prosthetic device and the corneal surface. The tear reservoir masks optical distortions from an irregular corneal surface, and in combination with the device itself, protects the ocular surface from an adverse external environment, including but not limited to dysfunctional evelids and margins. The design parameters are customized to allow for tear exchange underneath the device.
  The BostonSight PD Prosthetic Device may be shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the BostonSight PD Prosthetic Device is the Bausch & Lomb Frequent Replacement Contact Lens Case, with clearance under 510(k) K896685. When shipped "wet". The BostonSight PD Prosthetic Device 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 PD Prosthetic Device 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.

This document is a 510(k) Summary of Safety and Effectiveness for the BostonSight PD Prosthetic Device, a rigid gas permeable contact lens. As such, it does not contain a study or data proving the device meets acceptance criteria. Instead, it asserts substantial equivalence to predicate devices based on device characteristics, indications for use, and a reliance on prior clearances for materials and clinical performance of similar devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and statistical analyses cannot be extracted from this document. However, I can provide the available information:

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

The document does not explicitly state acceptance criteria in a quantitative manner for performance. Instead, it relies on substantial equivalence to predicate devices, implying that if the new device is sufficiently similar to the legally marketed predicate devices, it is considered safe and effective. The table below summarizes the comparison to predicate devices, which implicitly defines the "performance" as being comparable in key design and material aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a new study with a test set. Instead, it relies on prior clearances for predicate devices and materials. Therefore, no information on sample size for a test set or data provenance is available here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new study with a test set requiring ground truth establishment is described in this submission.

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

Not applicable.

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

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

Not applicable.

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

Not applicable, as no new study with a test set requiring ground truth establishment is described in this submission. The "ground truth" for contact lens performance and safety is typically established through clinical trials submitted for PMA devices or through extensive post-market experience for predicate devices.

8. The sample size for the training set

Not applicable, as no new clinical study with a training set is described.

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

Not applicable.

Summary based on the provided document:

The BostonSight PD Prosthetic Device gained 510(k) clearance by asserting substantial equivalence to existing legally marketed predicate devices. The "study" proving it meets acceptance criteria is primarily an analysis of its characteristics (materials, design, intended use) compared to previously cleared devices.

Specifically, the submission cross-references:

• Non-clinical studies and part of the clinical assessment: BostonSight IC Corneal & Scleral Lens (K153066).
• Therapeutic indications for use and device design: Boston® Scleral (itafluorofocon B) RGP Contact Lens (P860022/S40).
• Clinical studies for specific materials:
  • OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lenses (K033594)
  • Boston EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses (K022128)
  • Boston XO2 (hexafocon B) Daily Wear Contact Lens (K071266)

The document specifies that the new device does not raise different questions of safety and effectiveness than the identified predicate devices. Therefore, direct "acceptance criteria" and "device performance" in the context of a new, standalone study (as is often the case for AI/diagnostic devices) are not presented.

Ask a specific question about this device