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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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