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Boston SIMPLUS Multi-Action Solution is for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.

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

Here's a breakdown of the acceptance criteria and the studies for the Boston SIMPLUS Multi-Action Solution, as extracted from the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Toxicology: Not explicitly stated as a numerical sample size but involved testing Boston SIMPLUS Multi-Action Solution, fluoro silicone acrylate lenses cycled in the solution, and silicone acrylate lenses cycled in the solution. Provenance: Not specified, but generally in-vitro lab studies.
   • Cleaning Studies (in-vitro): Not explicitly stated as numerical sample sizes for the deposition models. Provenance: Lab studies. For the clinical lens cleanliness evaluation, it's tied to the clinical study.
   • Lens Compatibility Studies: Not explicitly stated as numerical sample sizes. Provenance: Lab studies.
   • Microbiology Studies: Not explicitly stated as numerical sample sizes, but involved conducting various efficacy tests with microorganisms. Provenance: Lab studies.
   • Clinical Studies: The number of patients in the multi-site randomized controlled clinical study is not explicitly stated. It involved patients wearing lenses daily. Provenance: Multi-site clinical study (prospective, as patients were instructed on use and evaluated). Country of origin is not specified.

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

   • Toxicology, Cleaning (in-vitro), Lens Compatibility, Microbiology: These are laboratory-based tests with objective endpoints (e.g., cell lysis, cleaning scores, microbial kill rates). Ground truth is established by standard laboratory protocols and measurements, not subjective expert assessment in the same way clinical diagnoses are made.
   • Clinical Studies: Evaluations included "visual acuity, lens surface characteristics, and physiological response." The interpretation of "Grade 2 or greater slit lamp findings" likely involved clinicians (e.g., ophthalmologists, optometrists), but the specific number and qualifications of these experts are not provided. Similarly, visual acuity measurements are objective (Snellen chart equivalent), but the assessment of "lens surface characteristics" and "physiological response" by clinicians would constitute the ground truth for these clinical endpoints.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • For the laboratory-based studies (toxicology, cleaning, lens compatibility, microbiology), the ground truth relies on direct experimental results and measurements against predefined standards. Adjudication in the sense of multiple human readers resolving disagreements is not applicable or described.
   • For the clinical study, while evaluations were performed, the document does not specify any adjudication method for resolving discrepancies if individual evaluators differed in their assessments of slit lamp findings or lens surface characteristics.

4. 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:

   • This submission describes the evaluation of a contact lens care solution, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was performed or is relevant to this device.

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

   • This is not an AI algorithm. It is a chemical solution for contact lens care. Therefore, no standalone algorithm performance study was done.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Toxicology: In-vitro cellular responses (absence of lysis, absence of irritation).
   • Cleaning Studies: Laboratory measurement of protein/lipid removal, visual/image analysis of lens cleanliness.
   • Lens Compatibility: Measurement of physical lens parameters and cosmetic appearance.
   • Microbiology Studies: Quantitative microbial reduction based on standardized methods.
   • Clinical Studies: Clinical assessments by healthcare professionals (for slit lamp findings, lens surface characteristics, physiological response) and objective measurements (visual acuity). The safety and efficacy endpoints relied on aggregated clinical data and statistical comparisons.

7. The sample size for the training set:

   • This is for a contact lens care solution, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not applicable. The development of the solution involved chemical formulation and iterative testing, which is a different paradigm from training an AI model.

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

   • Again, as this is not an AI device, the concept of a training set and its associated ground truth establishment is not applicable.

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