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This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently ancounter syringes and other sharps during searches of suspects, vahicles, property or location.

A ans piece aluminum container designed for the wate and examinated needles and syringes. Container is designed of thin walled puncture resistant 6081 aluminum with a screw on leak proof lld. Container is designed to held up to two (2) 1cc syringes and is completely disposable in accordance with local and state regulations.

The provided text describes a 510(k) summary for the SC001 Sharps Container, not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable.

However, I can extract information related to the device's acceptance criteria and the "study" (referring to the testing performed) that supports these criteria based on the provided text.

Here's a breakdown of the requested information, adapted for a non-AI/ML medical device submission:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text mentions "a 1cc Insulin syringe with a .5 inch needle of .014 OD thickness." It then states, "It was found that in every situation that the needle bent..." This suggests multiple tests were performed with at least one representative needle, but a specific number of tests or needles is not quantified as a "sample size" in the way it would be for a statistical study. The "shake test" also implies testing with contained needles.
• Data Provenance: Not explicitly stated, but the testing was conducted by or for Imagination Medical Inc. in the context of a 510(k) submission to the FDA. The tests appear to be laboratory-based and conducted specifically for this submission. There is no information regarding country of origin for data or if it was retrospective/prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. For this type of physical device testing, "ground truth" is established through direct measurements and observations of the device's physical properties and behavior under specified conditions, not through expert consensus on interpretations. The "truth" is the physical outcome of the test.

4. Adjudication Method for the Test Set

• Not applicable. Evaluation was based on direct physical testing outcomes (e.g., did the needle penetrate? did it leak? did it bend?). There's no indication of multiple observers or a need for adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not relevant for a sharps container. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess changes in diagnostic accuracy or efficiency.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This refers to AI algorithm performance and is not applicable to a physical sharps container.

7. The Type of Ground Truth Used

• Observed Physical Properties and Test Outcomes: The ground truth was established by directly observing the outcomes of engineered tests. For example, the force required to bend a needle, the force required to penetrate the container, and whether needles penetrated the container during a shake test.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no training set for this type of device.

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