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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:

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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.

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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.

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BOSTON XO (hexafocon A) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and nresbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer. The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A name has been adopted by the United States Adopted Names Council (USAN).

The provided text describes the BOSTON XO (hexafocon A) Contact Lens Material, and its submission for 510(k) clearance, asserting substantial equivalence to the predicate device, BOSTON ES (enflufocon A). The document focuses on preclinical and clinical studies conducted to support this claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the clinical study in the format of a target value to be met. Instead, it concludes equivalence to the predicate device. The preclinical tests had requirements that were met.

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

• Sample Size (Clinical Study):
  • Enrolled: 128 eyes (64 patients)
  • Completed Study: 102 eyes (51 patients)
• Data Provenance: The document does not explicitly state the country of origin. It does state that "3 Investigators" were involved, which often implies a multi-site study, but specific locations are not provided. The study was prospective, as patients were "entered into the study" and followed.

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

The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for the clinical study in the way one might assess an AI diagnostic device. Instead, the "safety and efficacy measures" were assessed by the clinical investigators. The document mentions "3 Investigators" who entered patients into the study. Their specific qualifications are not detailed beyond "Investigators."

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical study's safety and efficacy measures. The results are presented as conclusions from the study, without mentioning independent adjudication or consensus review of specific findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the evaluation of a contact lens material, not an AI-assisted diagnostic system. Therefore, assessing how much human readers improve with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study

No, a standalone performance study in the context of an "algorithm only" or AI system was not conducted. This document describes the evaluation of a contact lens material, which does not involve an algorithm or AI.

7. Type of Ground Truth Used

For the preclinical tests, the "ground truth" was based on established standard testing methodologies (e.g., USP XXII, Systemic Injection Test requirements) and observable physical changes.

For the clinical study, the "ground truth" for safety and efficacy was established through clinical observations and measurements by the investigators. These included:

• Adverse Events (self-reported and observed)
• Positive Slit Lamp Findings
• Symptoms/Complaints (patient-reported)
• Keratometry Changes (objective measurement)
• Refractive Changes (objective measurement)
• Lens Visual Acuity (objective measurement)
• Lens VA Line Changes (objective measurement)
• Lens Deposits (objective observation/grading)
• Lens Wettability (objective observation/grading)

This constitutes a form of expert assessment and objective measurement in a clinical setting.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a medical device (contact lens material) and its evaluation methods do not involve AI training. Therefore, this information is not applicable.

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

As there is no mention of a training set for an AI system, this question is not applicable.

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