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STORE NAME Multi-Purpose Solution is indicated for use in cleaning, chemical (NOT HEAT) disinfection, and storing of soft (hydrophilic) contact leases.

A sterile isotatic, phosphate buffered saline solution containing polyoxyethylens polyoxypropylene block copolymer, preserved with 0.128% EDTA and 0.0001% Cosmocil CQ (polyhexamethylene biguanide).

Contains no chiorhaxidine or thimerosal.

Cleans, loosens and removes accurations of films, deposits and dabris from soft consist. Innissa, Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewels lenses before the lansas are placed on the eye.

Here's an analysis of the provided text regarding K980147, outlining the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Clinical Study Test Set (Eyes):
  • Test group: 491 eyes (419 completed, 72 discontinued)
  • Control (Multipurpose): 117 eyes (107 completed, 10 discontinued)
  • Control (Peroxide): 116 eyes (94 completed, 22 discontinued)
  • Total Eyes in Study (Clinical): 724 eyes
• Clinical Study Test Set (Examinations/Visits):
  • Test group: 2,990 eye examinations/scheduled visits
  • Control (Multipurpose): 750 eye examinations/scheduled visits
  • Control (Peroxide): 672 eye examinations/scheduled visits
• Data Provenance: The document does not explicitly state the country of origin. Given the FDA 510(k) submission, it is highly likely the study was conducted in the United States. The study appears to be prospective, as it involves tracking clinical outcomes and adverse events in subjects over time using the solution.
• Other Test Sets (for Chemistry, Toxicology, Microbiology): Sample sizes are not specified for these laboratory tests.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth within the clinical study. Given the nature of a clinical trial for contact lens solutions, "ground truth" would be established by the examining practitioners (e.g., ophthalmologists, optometrists, or trained study coordinators under their supervision) based on standardized clinical assessments (visual acuity tests, slit lamp examinations, patient symptom reports). No explicit "expert consensus" for specific case-by-case ground truth determination is mentioned beyond the standard clinical examination protocols.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (like 2+1, 3+1, none) for the clinical test set data. Clinical trials typically follow pre-defined protocols for data collection and assessment by trained investigators. Any disagreements or ambiguities in data interpretation would ideally be resolved according to the study protocol, but a formal adjudication process by external experts is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to compare the diagnostic performance of different readers (e.g., radiologists) on a set of cases, often in the context of imaging. This submission concerns a contact lens solution, and the clinical study evaluates the solution's performance in real-world use on patients, not diagnostic interpretation by multiple readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, in essence. The Chemistry, Toxicology, and Microbiology sections represent "standalone" performance evaluations of the device (the solution itself) without human-in-the-loop interaction in the context of clinical decision-making. These tests evaluate the intrinsic properties of the solution (sterility, disinfection efficacy, toxicity, etc.) in a controlled laboratory setting. The clinical study then evaluates the device's performance with human-in-the-loop (patients using the solution, and clinicians evaluating the outcomes).

7. The Type of Ground Truth Used

• Chemistry, Toxicology, Microbiology: The ground truth is established through laboratory test results against predefined chemical, biological, and safety standards (e.g., "non-cytotoxic," "passed stand-alone disinfection test," "sterile," "no acute ocular irritation").
• Clinical Studies: The ground truth is primarily based on clinical observations and patient-reported outcomes. This includes:
  • Clinical assessments: Visual acuity measurements, slit lamp findings (e.g., presence/absence of edema, staining, hyperemia), and assessment of lens cleanliness by clinicians.
  • Patient-reported data: Symptoms, problems, and complaints provided by the patients during visits.
  • Adverse events: Clinically verified adverse reactions.

8. The Sample Size for the Training Set

The document does not mention a training set. This is a 510(k) submission for a medical device (contact lens solution), not an AI/Machine Learning device or a diagnostic test where a "training set" in the computational sense would be required. The data presented is from a clinical study and laboratory evaluations conducted to demonstrate safety and efficacy.

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

As no training set (in the context of AI/ML) is mentioned or implied, this question is not applicable. The "ground truth" for the various tests (chemistry, toxicology, microbiology, and clinical outcomes) was established as described in point 7.

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