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The Sage 2 Gallon Alternate Care Sharps Container is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, IV Cassettes, and Blood Needles. Sage 2 Gallon Alternate Care Sharps Containers are used in both clinical and nonclinical settings.

The Sage 2 Gallon Alternate Care Sharps Container is an injection molded, single use, non-sterile, disposable, sharps disposal container. The product is designed to hold sharps such as angio-caths, blood needles, lancets and various sized syringes and non-sharps such as drug infusion cassettes.

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance results, or any study conducted for the "2 Gallon Alternate Care Sharps Container."

The document is a 510(k) Pre-Market Notification summary, which focuses on:

• Company and Device Identification: Identifying Sage Products Inc. and the specific sharps container.
• General Description: Describing the device's basic characteristics (injection molded, single-use, non-sterile, disposable, designed to hold sharps).
• Substantial Equivalence: Listing predicate devices to which the current device is deemed substantially equivalent. This is a key part of the 510(k) process, arguing that the new device is as safe and effective as a legally marketed device.
• Design Features and Safety/Effectiveness Basis: This section lists the design features like impact resistance, puncture resistance, leak resistance, etc., and cites regulatory references (OSHA Bloodborne Pathogens 21 CFR 1910.1030) as the basis for these features. It does not provide acceptance criteria values or test results of the device against these features. It only states why these features are important.
• FDA Clearance Letter: Confirming that the FDA has reviewed the notification and determined the device is substantially equivalent, allowing it to be marketed.
• Indications For Use: Stating the intended purpose of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: No test set or study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on regulatory clearance based on substantial equivalence to existing devices, not on detailed performance study results against specific acceptance criteria.

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