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It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.

The Sharps container is single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. It is made of injection molded polypropylene plastic, and is composed of base, lid, closure and handle (except pocket collectors). No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers.

The provided text is a 510(k) Summary for a Sharps Container. It describes the device, its intended use, and its similarities to a predicate device, along with performance testing. However, it does not contain information about an AI/ML-based medical device. Therefore, I cannot generate the requested information about acceptance criteria, study details, expert involvement, or AI-specific performance metrics.

The document discusses the following types of tests:

• ASTM F2132-01(2008): Standard Specification for a Sharps Containers
• ISO 23907-1: Sharps containers - Part 1: Requirements and test methods - Sharps containers for single use
• 49 CFR 178.606 Stacking: Regulations for stacking of packaging for hazardous materials.
• 49 CFR 178.608 Vibration: Regulations for vibration testing of packaging for hazardous materials.

These are physical performance tests for a sharps container, ensuring its safety and appropriate containment of hazardous waste, not tests related to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I am unable to fulfill your request as the provided input does not describe an AI/ML medical device.

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