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The Sharps Compliance Container is a disposable infectious waste container in 1 gallon, 2 gallon and 3 gallon sizes, intended for use by laypersons or health professionals, in small usage areas in clinical and non-clinical settings, such as: phlebotomy, nursing homes, homes, isolation, doctors office, clinics, labs, or school nurses office. The Sharps Compliance Container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations.

The Sharps Compliance Container is a sharps container (disposable infectious waste container) in 1 gallon, 2 gallon and 3 gallon sizes designed to meet Occupational Safety and Health Administration ("OSHA") regulations on bloodborne pathogens (29 C.F.R. 1910.1030).

The provided text is for a Sharps Compliance Container (K083129), which is a physical medical device (a sharps container). The 510(k) summary and FDA letter clearly indicate that this submission is for a physical product and its intended use, rather than a diagnostic AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, and comparative effectiveness for an AI/ML device is not applicable to this document.

The submission focuses on demonstrating substantial equivalence to a predicate device (Sage 2 Gallon Alternate Care Sharps Container K973911) based on design and intended use, following guidelines for sharps containers. The device does not involve AI, ML, or any diagnostic algorithms.

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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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