Search Results

The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with nondiseased 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.

The BOSTON ES (enflufocon A) and BOSTON EO (enflufocon B) are rigid gas permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorher.

BOSTON XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.

The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lenses may also be supplied clear (no tint).

The provided text describes information for the "BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON XO® (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES". However, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way a clinical trial would for a novel medical device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size) are not applicable or not provided in this type of document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail sense against pre-defined thresholds. Instead, it reports the physical/optical properties of the lenses, which are implicitly accepted given their substantial equivalence claim. The reported properties are presented below:

• gas to gas method
• polarographic method (ISO/Fatt)
• ***(x 10⁻¹¹ (cm³ O₂ • cm)/ (cm² • sec • mmHg) @ 35° C}

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

Not applicable. This is a 510(k) submission based on substantial equivalence to existing predicate devices, not a clinical trial with a "test set" in the context of AI/software performance. The safety and efficacy were previously demonstrated in earlier 510(k) clearances.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a 510(k) submission.

4. Adjudication method for the test set

Not applicable. This is a 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

Not applicable. This is a contact lens device, not an AI-based diagnostic tool requiring MRMC studies.

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

Not applicable. This is a contact lens device, not an algorithm.

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

The document supports the safety and effectiveness of the device by demonstrating its physical/optical properties and clinical indications are substantially equivalent to previously cleared predicate devices. The "ground truth" here is regulatory acceptance based on comparisons to established, safe, and effective devices, as well as adherence to recognized material property standards.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical device, not an AI algorithm.

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

Not applicable. This is a 510(k) submission for a physical device, not an AI algorithm.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The document itself is the "study" in the context of a 510(k). It states:

• "The safety and efficacy of BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses was demonstrated in 510(k) Premarket Notifications as follows: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively. The most recent Premarket Notification for all three materials (Boston ES, EO, and XO) was 510(k) K013762, cleared April 3, 2002, for a new indication for keratoconus."
• "BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplastv."

This means the "study" is a historical chain of prior 510(k) clearances and the demonstration that the current devices' physical properties and indications are substantially equivalent to those already cleared. There is no new clinical trial data presented in this specific 510(k) summary (K053124) to validate performance against novel acceptance criteria. Instead, the "acceptance criteria" are effectively met by demonstrating that the device is the same or very similar to already approved predicate devices.

Ask a specific question about this device

The QUASAR® (hybufocon A, hexafocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The QUASAR TORIC® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The QUASAR PLUS® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The QUASAR® - QUASAR PLUS® - QUASAR TORIC® Contact Lenses are fabricated from the hydrophobic contact lens materials (hybufocon A, paflufocon B). When placed on the human cornea, the QUASAR® - QUASAR PLUS® - QUASAR TORIC® rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

The QUASAR® and QUASAR TORIC® series of contact lenses are aspheric from center to edge. The QUASAR® and QUASAR TORIC® are designed with the central area consisting of a modified conic profile, which is designed to flatten at a much slower rate than a fixed elliptical curve. This improves centration characteristics and eliminates any significant positive/astigmatic aberration over the central 7mm. This aspheric geometry results in slight apical clearance and close alignment over the mid-peripheral cornea. Edge clearance is achieved by the addition of a second aspheric edge band resulting in the optimal final tear lens profile as shown in the figure below. Constant apical and edge clearance are maintained independent of base curve and the total diameter of the lens.

The QUASAR PLUS® multifocal design cleverly utilizes the eyes' own tears to provide precise vision at distance, intermediate and near. The QUASAR PLUS® is a distance center multifocal with a graduated annulus of near vision where the progressive power is incorporated into the optics back surface of the The aspheric design of the optical zone is based upon the patient's degree of ametropia and the lens. reading addition required. By incorporating the asphericity into the back surface, the profile of the tear film will be altered resulting in a fluorescein pattern different than that of a single vision lens.

The provided text does not describe a study involving acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria in the context of an AI/human comparative effectiveness or standalone algorithm performance.

Instead, the document is a 510(k) Premarket Notification for contact lenses, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The tables provided present characteristics of the new device (QUASAR® - QUASAR PLUS® - QUASAR TORIC® contact lenses) and compare them to predicate devices, but these are material and manufacturing specifications, not performance metrics based on a clinical trial.

Therefore, I cannot provide the requested information from the given input. The categories below are not applicable to the provided document.

1. Table of acceptance criteria and the reported device performance:
N/A - The document describes substantial equivalence based on material properties and intended use, not performance metrics from a clinical study with acceptance criteria.

2. Sample size used for the test set and the data provenance:
N/A - No test set or clinical data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A - No ground truth establishment is described.

4. Adjudication method for the test set:
N/A - No adjudication method 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:
N/A - This document is for contact lenses and does not involve AI or human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A - This document is for contact lenses and does not involve an algorithm.

7. The type of ground truth used:
N/A - No ground truth is described.

8. The sample size for the training set:
N/A - No training set is described.

9. How the ground truth for the training set was established:
N/A - No ground truth for a training set is described.

Ask a specific question about this device

FP(hexafocon A) and ASP(hexafocon A) RGP Contact Lens are indicated for daily wear for the correction of refractive amptropia (myopia, lyperopia, astigmatism) in aphakic and not- aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical(not heat) disinfecting system only.

The FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are is hemispherical shell of the following dimentions.

· Diameter: 8.00 to 10.00mm
· Center Thickness: 0.10 to 0.50mm
· Base Curve: 6.00 to 9.00mm
· Power: -20.0 to +20.0 diopter

The physical properties of the lens are

• · Specific Gravity 1.27
• · Refractive Index 1.415
• · Light Transmittance 92%
• · Surface Character Hydrophobic
• 490 · Wetting Angle
• · Water Content <1%
• · Hardness(shore D) 81
• 140*(100**) { × 10 + ( cm3 O2 cm ) ( cm2 sec mm Hg ) @ 3 5 ℃ } · Oxygen Permeability
• • gas to gas method
• ** polarographic method(ISO/Fatt)

The provided text does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

This document is a 510(k) Summary of Safety and Effectiveness for a rigid gas permeable contact lens, indicating that the device is substantially equivalent to previously cleared devices. It primarily focuses on the device's technical specifications, intended use, and its equivalence to predicate devices based on material properties and function.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods as this information is not present in the provided text.

Ask a specific question about this device

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

The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.

BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.

The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).

Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSTON ES®, BOSTON EO®, and BOSTON® XO Rigid Gas Permeable Contact Lenses.

It's important to note that this document is a 510(k) summary, which often points to prior submissions and substantial equivalence rather than detailing a new comprehensive clinical study for the specific device being cleared.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to a predicate device (BOSTON® II itafocon A). This means that the new devices are considered safe and effective because they are as safe and effective as a legally marketed device.

The "performance" for these new devices is presented not as a comparison against specific numerical targets, but as their fundamental physical and optical properties, which are then implicitly considered acceptable because they fall within the parameters of what is deemed safe and effective for rigid gas permeable contact lenses, similar to the predicate.

Notes:

• Specific numerical acceptance criteria for each physical/optical property are not explicitly stated in this 510(k) summary, but are implied to be acceptable based on the predicate and general RGP lens standards.
• The "at least %" for Light Transmittance in BOSTON ES and EO is an incomplete entry in the original document.

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

The document states: "The safety and efficacy of BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas PermeableContact Lenses was demonstrated in 510(k) Premarket Notifications: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively."

This means that the current 510(k) (K013762) is leveraging previous clearances. The specific details of the test sets (sample sizes, prospective/retrospective, country of origin) for those earlier 510(k)s are not provided in this summary document. This 510(k) relies on the fact that those previous submissions adequately demonstrated safety and efficacy.

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

This information is not provided in the summary. For 510(k) submissions, particularly for devices with a clear predicate, detailed expert adjudication for ground truth (as might be seen in AI/diagnostic device studies) is generally not required unless there's a novel aspect requiring new clinical data. The primary "ground truth" here is the established safety and efficacy of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the summary.

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 study was done or is mentioned. This type of study is specifically relevant for AI-powered diagnostic devices where human interpretation interacts with AI output. These contact lenses are a medical device, not an AI diagnostic tool.

6. 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. Its performance is inherent in its physical and material properties, and its interaction is directly with the human eye, not through an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary "ground truth" for these contact lenses, as presented in this 510(k) summary, is:

• Substantial Equivalence to a Predicate Device: The established safety and efficacy of the BOSTON II (itafocon A) Rigid Gas Permeable Contact Lens, which was approved under a Premarket Application (PMA P820065). This implies that the predicate device underwent comprehensive clinical trials and demonstrated safety and efficacy through clinical outcomes data, which then serves as the benchmark.
• Physical and Optical Property Characterization: The physical properties of the new lenses (e.g., oxygen permeability, refractive index) are measured and implicitly compared against accepted standards for RGP lenses, which are themselves derived from years of clinical experience and outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. As above, this is not an AI algorithm.

Ask a specific question about this device

The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens 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. The lens may be disinfected using a chemical disinfection system.

The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable spherical contact lens is intended for the correction of highly irregular comeas occurring naturally or from disease such as Pellucid Marginal Degeneration and keratoconus or from post surgery complications such as tilted grafts. The design is larger in diameter, with a 11.2 mm standard diameter that is sized to fit within the limbus. A spherical peripheral system is employed to insure maximum exchange of tears and adequate cleansing of the cornea from flushing action behind the lens. The lens material attributes and lens parameters are found in the package insert.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria for the Dyna Intra-Limbal Lens. Instead, it relies on the concept of "substantial equivalence" to predicate devices (Boston ES and Boston XO RGP lenses) and the demonstration of efficacy through a small clinical study for its new indication.

Therefore, the "acceptance criteria" can be inferred as:

• Safety profile equivalent to predicate devices.
• Manufacturing adherence to specified standards (ANSI Z80.20-1998) and cGMP.
• Clinical data supporting the efficacy of the new indication.

Since specific quantitative acceptance metrics are not provided, I cannot populate a table with "reported device performance" against them in the traditional sense. The document states:

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

• Sample Size for Test Set: 20 patients.
• Data Provenance: The document does not specify the country of origin. It is a "clinical data presented" which implies a prospective study, though this is not explicitly stated. The nature of the device (contact lens) and the typical regulatory pathway for such devices often involve prospective clinical trials.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical data. It simply mentions "clinical data," implying a clinical trial where patient outcomes and observations by eye care professionals would serve as the basis for efficacy.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done or reported. The study described is a direct clinical evaluation of the device's performance in patients, not a comparison of human readers with and without AI assistance. The device itself is a contact lens, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a contact lens, not an AI algorithm. No standalone algorithm performance study was mentioned.

7. The Type of Ground Truth Used

The ground truth used for evaluating the efficacy of the Dyna Intra-Limbal Lens in the clinical study was likely patient outcomes and clinical observations by eye care professionals. This would include metrics like visual acuity improvements, comfort, fit, and successful management of irregular corneal conditions, as assessed by the prescribing and follow-up clinicians. The document refers to "efficacy of the Dyna Intra-Limbal Lens" supported by "clinical data."

8. The Sample Size for the Training Set

This question is not applicable. The Dyna Intra-Limbal Lens is a medical device (contact lens), not an AI algorithm that requires a training set. The "training" in this context would refer to the historical data and experience used to design the device, which is not quantified in terms of a "training set."

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

This question is not applicable for the same reason as #8. No ground truth for a "training set" of an AI algorithm was established. The "ground truth" for the device's design would stem from established ophthalmic knowledge, contact lens science, and the performance of predicate devices.

Ask a specific question about this device