Search Results

The Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, bresbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -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 Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for sphere
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm
• with diameter of 7.0 to 21.0 mm
  The lens material (oprifocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material.

The provided document is a 510(k) Summary for the Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, which seeks to establish substantial equivalence to a predicate device. As such, it does not detail a study involving AI or human readers, or clinical trials with acceptance criteria for device performance in the way a new medical device would typically be evaluated for accuracy or diagnostic capability.

Instead, the "acceptance criteria" here refers to demonstrating that the new device's material properties and design are substantially equivalent to a legally marketed predicate device, as per FDA guidelines for daily wear contact lenses. The "study" mentioned is primarily non-clinical testing of the material properties.

Here's a breakdown based on the information provided, framed to address your specific questions where applicable, and noting where information is not relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the properties of the predicate device (Boston Equalens II) and the "performance" is the new device's (Acuity 85) equivalent properties. The goal is to show the new device meets or is comparable to the predicate's established properties.

Note: The differences in Refractive Index, Oxygen Permeability, Specific Gravity, Hardness, and Modulus between the new and predicate device are considered acceptable for demonstrating substantial equivalence for this type of device, falling within expected manufacturing variations or improvements that do not raise new questions of safety or effectiveness. For example, a higher oxygen permeability is generally considered an improvement for contact lenses.

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

This submission relies on non-clinical testing of the lens material. The sample size for material testing is not explicitly stated in the document, but it would typically involve multiple batches or samples of the material to ensure consistency. The provenance is internal to Acuity Polymers, Inc., where the oprifocon A lens material is manufactured. This is laboratory testing, not human subject data, so "retrospective" or "prospective" as applied to clinical studies is not relevant 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)

This type of submission does not involve "experts" establishing ground truth in the context of diagnostic interpretation. The "ground truth" for material properties is established by standardized laboratory testing methods and measurements (e.g., ISO standards or internal validated methods). The document states the material testing meets ISO 10993-1 (2009) for biocompatibility and FDA Daily Wear Contact Lens Guidance Document standards. The staff performing these tests would be qualified laboratory technicians and scientists, but their number and specific qualifications are not detailed in this summary.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of medical images or patient outcomes. This is not relevant to the non-clinical material testing conducted for this 510(k) submission.

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

No MRMC comparative effectiveness study was done, as this submission is for a contact lens material and design, not an AI-powered diagnostic device. The concept of "human readers improve with AI" is not applicable here.

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

No standalone algorithm performance study was done. This device is a physical contact lens, not a software algorithm.

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

The "ground truth" in this context refers to the objectively measured chemical, mechanical, and optical characteristics of the oprifocon A material and the finished lens, obtained through established laboratory testing protocols. These metrics are then compared to the established properties of the predicate device material and design, as well as relevant guidance documents (e.g., FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009)).

8. The sample size for the training set

This submission did not involve a "training set" in the context of machine learning or deep learning algorithms. It concerns the substantial equivalence of a medical device (contact lens) based on material properties and design.

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

As there was no training set for an algorithm, this question is not applicable. The "ground truth" for the material characteristics was established through laboratory testing and conformity to existing standards and predicate device properties.

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

Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal 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.

Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.

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 prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.

The lens may be disinfected using a chemical disinfection system only.

The Menicon Z™ lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents.

The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

This 510(k) summary describes a rigid gas permeable contact lens, not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria, as well as several other elements of the prompt (such as number of experts, adjudication method, AI improvement, training set size, etc.), are not applicable to this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices.

However, based on the information provided, here's an attempt to answer the relevant aspects of your request regarding acceptance criteria and the "study" that proves the device meets them, interpreting "acceptance criteria" as meeting the chemical and physical properties of similar, already-approved devices, and "study" as the comparison of these properties:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly defined by the properties of the predicate devices. The Menicon Z™ rigid gas permeable contact lens is considered to meet these criteria if its material properties are comparable to those of the predicate devices.

*Note: The Menicon Z™ Dk values are higher than the predicate examples, which is generally considered an advantage for contact lenses.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. This submission relies on material property comparisons and prior clearances, not a clinical test set in the traditional sense for an AI/ML device.
• Data Provenance: The data provided (material properties) are intrinsic to the device material and are likely derived from laboratory testing conducted by Menicon Co., Ltd. The document does not specify the country of origin of this specific material data or if it's retrospective/prospective outside of the general timeframe of the predicate device clearances.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of an AI/ML device, is not established for this type of submission. The "ground truth" for material properties would be the measured values determined by standardized laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring expert adjudication.

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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the measured physical and optical properties of the Menicon Z™ material, which are compared against those of already cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and thus there is no training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set.

Ask a specific question about this device