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Oak Ridge Products Sharps containers are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.

The 1 quart Phlebotomy container is intended to be used with an appropriate mounting device.

The 5.4 quart is intended to be used with an appropriate mounting device.

The 2 gallon container is intended to be used in areas where there is no unsupervised patient access.

The Oak Ridge Products Sharps Containers are an injection molded polypropylene plastic designed for a single-use. The containers are puncture resistant, leak resistant on the sides and bottom, closable and stable. The products have engraved maximum fill lines on the containers and instructions for locking the container closed. Labels are white with black text and a black bio-hazard symbol printed on an orange-red background. Labels are adhered to the containers at the time of manufacture with the fill line warning matching the engraved fill line on the container.

The Oak Ridge Products Sharps Containers are made of three parts (a base, a lid, and a closure) that form a single unit. Parts are nested together to reduce storage and shipping requirements. The bases are offered in natural (translucent) or colored (red). These are available in three sizes; 1) 1 quart Phlebotomy, 2) 5.4 quart for Patient room and 3) 2 gallon containers. Lids and closures are uncolored translucent material. The translucent nature of the product allows for a visual determination of content level.

The acceptance criteria for the Oak Ridge Products Sharps Containers are based on recognized consensus standards and regulations. The study proving the device meets these criteria involved non-clinical performance bench testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each performance test. It only states that the products were tested by "appropriate methods" and involved "product performance testing." The data provenance can be inferred as being from internal company testing and an "independent materials testing lab" for puncture resistance. No specific country of origin for the data is mentioned, but the company is based in McHenry, Illinois, USA. The testing is non-clinical and would be considered prospective for the device being evaluated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the study involved non-clinical bench testing of a physical device against established technical standards, rather than expert evaluation of data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the study involved non-clinical bench testing and adherence to predefined pass/fail criteria from recognized standards, not subjective adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a physical sharps container, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical sharps container, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on the objective, measurable pass/fail criteria defined within the recognized consensus standards: ASTM F2132-01, OSHA 29CFR 1910:1030, and ISO 23907. These standards define the acceptable performance limits for physical characteristics such as puncture resistance, leak resistance, stability, and proper function of access and closure mechanisms.

8. The sample size for the training set

This section is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the conventional sense. The product design and manufacturing processes are likely informed by engineering principles and previous product iterations, but not a "training set."

9. How the ground truth for the training set was established

This section is not applicable for the reasons mentioned above.

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