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The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc.

Sharps Compliance Sharps Transport Tube Model 50035

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Sharps Compliance Sharps Transport Tube Model 50035". This document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, study design (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set information) is not available within the provided text.

The closest information available is the intended use of the device: "The Sharps Transport Tube with screw top lid is a single use or single patient use, non-sterile, disposable, sharps transportation container used in setting where traditional sharps containers cannot be conveniently accessible, such as home use, traveling, EMS, home health, etc." This describes the function of the device but not quantifiable acceptance criteria or performance metrics.

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