Search Results

The Acuity 58™ (en:flufocon B) Rigid Gas Permeable Contact 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 nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +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 58™ (enflufocon B) 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 (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.

The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.

Here's an attempt to extract the requested information based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.

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

The submission states that no clinical studies were deemed necessary (Page 5, Section 13) because "no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material." Therefore, there isn't a specific "test set" in the context of a clinical trial with human subjects. The evaluation for substantial equivalence was based on non-clinical (bench) testing of the material and physical characteristics.

The data provenance for these non-clinical tests is not specified in terms of country of origin or retrospective/prospective nature, as they are laboratory tests performed by the manufacturer, Acuity Polymers, Inc., located in Rochester, NY, USA.

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

Not applicable. As no clinical studies were performed, there was no "ground truth" derived from expert assessment of patient outcomes or conditions. The "ground truth" for material properties would be established by standard laboratory testing methodologies.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical 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 device is a rigid gas permeable contact lens, not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. This device is a physical medical device (contact lens), not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth was established by adherence to regulatory standards and guidance documents: FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.

For the chemical, mechanical, and optical characteristics, the "ground truth" for comparison was the properties of the predicate device material (Boston EO Material, enflufocon B). The new device's properties were compared against these established values to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable.

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, 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 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