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COMPLETE® brand Lubricating and Rewetting Drops are indicated to lubricate and rewet soft (hydrophilic) contact lenses during lens wear.
COMPLETE® brand Lubricating and Rewetting Drops are used to lubricate and rewet soft (hydrophilic) contact lenses before application and during lens wear.

COMPLETE® brand Lubricating and Rewetting Drops are a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand Lubricating and Rewetting Drops contain no chlorhexidine or 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 510(k) summary for "COMPLETE® brand Lubricating and Rewetting Drops" does not include a detailed table of acceptance criteria with specific quantitative thresholds or a singular study explicitly designed to "prove" the device meets these criteria in the typical sense of a diagnostic device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (the existing formulation of the product and other contact lens multi-purpose, lubricating and rewetting solutions) through a series of non-clinical and limited clinical studies. The "acceptance criteria" are implied by the successful outcomes of these tests, showing the new formulation is as safe and effective as the predicate.

Here's a breakdown of the information based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, a formal table of quantitative acceptance criteria is not present in the provided text. The "acceptance criteria" are implicitly met when the device performs comparably or better than the predicate/controls in various safety and effectiveness tests.

2. Sample Size Used for the Test Set and Data Provenance

• Nonclinical/Toxicology Studies:
  • Cytotoxicity: Not specified, but involved comparisons between new COMPLETE®, old COMPLETE®, ReNu MultiPlus, and BAK.
  • Sensitization: 25 female Hartley guinea pigs.
  • Acute Oral Toxicity: 40 (20 male and 20 female) CD albino rats.
  • 28-Day Ocular Safety Study: 12 female New Zealand white rabbits.
• Clinical Study (referenced from K981168, used for multi-purpose solution):
  • Total subjects: 124
  • Investigational MPS group: 62 (2 disqualified, leaving 60 evaluable)
  • Control (COMPLETE® MPS) group: 62 evaluable
• Data Provenance: The animal studies were conducted in rabbits, guinea pigs, and rats. The clinical study was conducted with human subjects. The country of origin is not specified but implicitly in the USA as it's an FDA submission. The clinical study was prospective, as it involved enrolling subjects and following them. The animal studies are also implicitly prospective evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "experts" establishing a ground truth in the context of diagnostic performance for this device. This product is a lens care solution, not a diagnostic tool requiring expert interpretation of results. The "ground truth" for safety and performance comes from direct observation (e.g., ocular irritation, cell survival, animal health) and clinical findings by investigators.

4. Adjudication Method for the Test Set

Not applicable. This is not a diagnostic device with ambiguous readings requiring adjudication. Clinical observations and measurements were performed and analyzed statistically.

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 a diagnostic device or an AI-assisted interpretation system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not a software algorithm; it's a physical product (liquid solution).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is based on a combination of:

• Microbiological assays: Meeting established USP modified criteria and test requirements.
• Cell cultures: Direct observation of cell survival and neutral red retention.
• Animal models: Direct observation of dermal reactions, survival rates, detailed ocular examinations (pachometry, slit lamp, ophthalmoscopy), and histopathological evaluations. These are considered direct evidence of physiological response to the product.
• Clinical observations: Direct observation of adverse events, slit lamp findings, and patient-reported symptoms of discomfort by clinical investigators. These are considered outcomes data relevant to the product's safe use and patient acceptability.

8. The Sample Size for the Training Set

Not applicable. This product does not involve machine learning or AI, so there is no "training set."

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

Not applicable. There is no training set for this device.

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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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