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COMPLETE® brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

COMPLETE® brand Multi-Purpose Solution is a sterile, isotonic, buffered, preserved solution. This aqueous formulation includes purified water, sodium chloride, hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, Poloxamer 237 as a surfactant, a phosphate buffer, and edetate disodium as a chelating agent. This preparation contains no chlorhexidine, no thimerosal and no other mercury containing ingredients. Both current and reformulated products are clear, colorless solutions packaged in plastic bottles with controlled dropper tips.

The provided document is a 510(k) summary for a contact lens solution, not an AI device. Therefore, many of the requested criteria, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only) performance," "sample size for the training set," and "number of experts used to establish the ground truth," are not applicable.

However, I can extract the relevant acceptance criteria and study information for the COMPLETE® brand Multi-Purpose Solution (Revised) as presented in the document.

Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical and Clinical)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Non-Clinical Studies: No specific sample sizes for each non-clinical test (e.g., solution compatibility, protein cleaning, microbiological, toxicology) are provided, only the results. The data provenance is not explicitly stated beyond "The product was tested with the same protocol used to test the prior (substantially equivalent) formulation."
• Clinical Study:
  • Total Subjects Enrolled: 124 subjects
  • Investigational MPS Group: 62 subjects (60 evaluable after disqualifications)
  • COMPLETE® MPS Group (Predicate): 62 subjects (all evaluable)
  • Data Provenance: Not specified (e.g., country of origin). A clinical study implies prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Non-Clinical: Not applicable in the context of expert consensus for ground truth as these are lab-based tests.
• Clinical: The clinical study involved "Six clinical investigators," but their specific qualifications or their role in establishing "ground truth" (beyond conducting the study and evaluating subjects) are not detailed.

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

• Not applicable as this is a clinical trial for a contact lens solution, not an imaging device requiring expert adjudication for ground truth. The "adjudication" in this context would be the assessment of individual investigators.

5. 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

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI algorithm. The device itself (contact lens solution) is "standalone" in its function, but this term typically refers to AI performance.

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

• Non-Clinical:
  • Solution Compatibility & Cleaning, Protein Cleaning: Lab-based quantitative measurements of cleaning efficacy.
  • Microbiological Studies: Adherence to established FDA guidelines (FDA's Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, USP Modified criteria).
  • Toxicology: Observation of biological responses in animal models and in vitro tests (cytotoxicity, sensitization, oral toxicity, ocular safety).
  • Stability: Accelerated aging tests to predict shelf-life.
• Clinical:
  • Safety Data: Clinical observations and measurements by investigators (slit lamp findings, visual acuity, refraction, keratometry, mire distortion) and reported adverse events.
  • Acceptability Data: Clinical observations and measurements by investigators (lens cleanliness, fit, discoloration, wearing time) and subjective symptom reporting by subjects (comfort, discomfort).

8. The sample size for the training set

• Not applicable as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI algorithm.

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