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The Vault is a single-use, disposable, non-sterile sharps transport container intended to be used by Paramedics and EMT's in their medical jump kits where larger sharps containers are not conveniently accessible. Its function is to be available for portable sharps containment as an alternative to using non-sharps containers or resheathing a needle with its original protective cover.

The VAULT is a single-use , disposable , non-sterile, sharps transport container intended to be used in areas where larger sharps containers are not conveniently accessible, normally in the field use in paramedic and EMT jump kits. The Vaults design allows for easy one handed use by the EMT. Its function is to be available for portable sharps containment and as a alternative to using non-sharps containers or resheathing a needle with its original protective cover.

The VAULT is a 1.5x 5 inch box designed to set horizontally in a jump kit. The lid is designed to remain open until use and then permanently close for transportation of the contaminated sharps for safe disposal.

Each box is labeled with a biohazard label. The VAULT is also a bright red color to meet OSHA standards for warning of biohazard danger.

Here's an analysis of the acceptance criteria and study information for "The VAULT" device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size used for the Test Set and the Data Provenance:

   • Sample Size: The document does not explicitly state a specific numerical sample size for most tests (e.g., "Numerous tests" for puncture resistance). For impact resistance, it refers to "The box" (singular), implying at least one box was tested. For capacity, it refers to "The vault" (singular).
   • Data Provenance: The document does not specify the country of origin or whether the tests were retrospective or prospective. It describes the testing methodologies performed by Stik Stoppers for "The VAULT."

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

   • Not applicable. The performance criteria are based on physical characteristics and functional tests of the device, not on expert interpretation of medical images or data. Therefore, "ground truth" in the medical diagnostic sense is not relevant here.

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

   • Not applicable. As noted above, this device relies on physical performance and functional testing rather than human interpretation requiring adjudication.

4. 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:

   • Not applicable. This is a medical device (sharps container), not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for the performance criteria is based on direct observation and measurement of the device's physical properties and functional performance under defined test conditions (e.g., whether the box leaked, whether needles punctured the box, whether the lid reopened).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model requiring training data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for a physical device.

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