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BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyocia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.

BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.

BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.

BOSTON SIMPLUS® Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).

Here's a breakdown of the acceptance criteria and the study details for the Bausch & Lomb BOSTON RGP Lenses wet-shipped in BOSTON SIMPLUS® Multi-Action Solution:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: The document mentions "examples of SA and FSA lenses" for bioburden testing and "The representative FSA lens was the Boston Equalens II RGP Contact Lens. The representative SA lens was the BOSTON IV RGP Contact Lens" for shelf-life testing. However, specific numerical sample sizes are not explicitly stated in the provided text.
   • Data Provenance: The studies appear to be retrospective laboratory studies conducted by the applicant, Bausch & Lomb, Inc., without specific mention of external sites or data origin.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • The document does not mention using experts to establish ground truth for the test set. The ground truth for biophysical and microbiological parameters would typically be established by standardized laboratory testing methods and accredited personnel, not necessarily "experts" in the clinical sense mentioned in the question.

3. Adjudication method for the test set:

   • Not applicable. This concept typically applies to studies involving human subjective evaluation or image interpretation where multiple raters' opinions need to be reconciled. The studies described are objective laboratory tests.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC comparative effectiveness study was not performed. This device is a contact lens, and the studies focused on its physical, optical, and microbiological stability, not on human reader performance or AI assistance.

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

   • Yes, in the sense that the tests were objective laboratory tests of the device itself. The performance evaluations were for the contact lenses and their storage solution, not an algorithm. The "standalone" performance here refers to the device's intrinsic characteristics as measured in controlled conditions.

6. The type of ground truth used:

   • Laboratory test results against established ISO standards and internal procedures.
     • For physical and optical properties, the ground truth was determined by measurements conforming to ISO 11987:1997 Ophthalmic Optics - Determination of Shelf-life; WI0523 GP Lens Wet Packaging Qualification Procedures.
     • For bioburden levels, the ground truth was determined by measurements against a specified minimum cfu value (<100 cfu / lens) using internal procedures.

7. The sample size for the training set:

   • Not applicable. This device is a physical product (contact lens and solution), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply.

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