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For use in hospitals, clinics, home use for the delivery of insulin to diabetics.

Lite Touch Syringes

The provided text is a clearance letter from the FDA for a device called "Lite-Touch Syringe." It does not contain information about the acceptance criteria, study details, or performance data of the device. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing it.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth used.
• Sample size for the training set or how its ground truth was established.

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