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

The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Clinical Test Set): 240 eyes (120 patients).
• Data Provenance: The document does not explicitly state the country of origin.
• Retrospective or Prospective: Prospective, as it describes a "clinical study carried out to evaluate the safety and efficacy" and mentions patient "entry into this study."

3. Number of Experts and Qualifications for Ground Truth

• The document mentions "8 Investigators" for the clinical study. It does not provide specific qualifications for these investigators (e.g., ophthalmologists, optometrists, years of experience). Their role was likely to conduct the clinical assessments and collect data as per the protocol.
• For preclinical tests (toxicology), the "ground truth" is based on established standards (e.g., USP XXII for cytotoxicity).

4. Adjudication Method

• The document states the study utilized a "controlled, double masked design." This implies that both the patients and the investigators were unaware of whether they were using the test or control lens.
• It does not specifically mention an independent adjudication method for clinical findings beyond the initial assessment by the investigators. The primary endpoints were defined as percentages of certain findings, implying a direct comparison of reported results.
• For the preclinical tests, the "adjudication" is based on meeting the defined requirements of the specific test (e.g., "meets the requirements of the Agar Diffusion Test").

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This study evaluates a contact lens material, not an AI or imaging device where human readers would interpret images. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) study was not done.
• This submission is for a medical device (contact lens material), not an algorithm or AI system.

7. Type of Ground Truth Used

• Clinical Study: The ground truth for safety was based on "Grade 2 or greater slit lamp findings" which are objective clinical observations made by the investigators. For efficacy, it was based on "lens visual acuities at the level of 20/40 or better," also an objective clinical measurement. These are considered expert clinical assessments/measurements.
• Preclinical Tests (Toxicology): The ground truth was based on established standardized test criteria (e.g., USP XXII for cytotoxicity, defined parameters for ocular irritation and systemic injection).
• Solution Compatibility: Ground truth was based on objective instrumental measurements of lens parameters (UV/vis spectra, base curve, diameter, power, surface quality) before and after cycles.

8. Sample Size for the Training Set

• Not applicable. This is a clinical study for a physical medical device (contact lens material), not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no training set for this type of device submission.

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