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OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

OTE MPS 045 Multi-Purpose Lens Care Solution is a sterile, buffered aqueous solution that contains sodium hyaluronate, poloxamer 407, boric acid, sodium borate, propylene glycol, and is preserved with Polyaminopropyl Biguanide Hydrochloride 0.00002%, Polyquaternium-2 0.00043%, and edetate disodium.

The provided text describes a 510(k) premarket notification for the "OTE MPS 045 Multi-Purpose Lens Care Solution." The document focuses on demonstrating substantial equivalence to a predicate device, BioTrue® Multi-Purpose Solution, rather than providing explicit acceptance criteria and performance against those criteria in a typical AI/device study format.

However, I can extract the relevant information from the "Clinical Data" section to answer your request in the closest possible way, interpreting "acceptance criteria" as the primary endpoints of the clinical study and "reported device performance" as the study findings for those endpoints.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

For the clinical study, the "acceptance criteria" can be interpreted as the successful demonstration of non-inferiority for the specified primary endpoints.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 199 subjects.
• Data Provenance: The study was a multi-center study, but specific country of origin is not mentioned. It was a prospective study, as it involved subjects using the device for a duration of 30 days.

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

The document does not specify the number of experts, nor their qualifications, used to establish ground truth for the clinical study endpoints. It mentions "Investigator" as one of the masked parties, suggesting that clinical investigators (likely ophthalmologists or optometrists) assessed the endpoints, but no specific number or detailed qualifications are provided.

4. Adjudication method for the test set

The document does not describe an adjudication method. It was a "double-masked (Investigator and Subject)" study, implying that the investigator assessments would form the basis of the outcome.

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

• MRMC Study: No, this was not an MRMC study related to AI. This was a clinical trial comparing a new lens care solution to a predicate device.
• Effect size of human readers improve with AI: Not applicable, as this study does not involve AI assistance for human readers.

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

No, this was a clinical study involving human subjects and a medical device (lens care solution), not an algorithm or AI.

7. The type of ground truth used

The ground truth was established through direct clinical observations and assessments by investigators (implied to be eye care practitioners) and subject-reported outcomes during the 30-day clinical study. This would encompass clinical findings (slit lamp, hyperemia, corneal staining) and subjective reports (comfort, visual acuity).

8. The sample size for the training set

Not applicable. The provided document describes a clinical study for a traditional medical device (lens care solution), not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device and study.

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