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The Travel Savvy Sharps Container is a single-use device intended for disposal of sharps waste by a single user in a private site of use. When mounted with the appropriate bracket, the Travel Savvy Sharps Container can be used for sharps disposal in vehicles.

The B Travel Savvy Sharps Container is a single use device designed for the safe disposal of regulated medical waste such as contaminated sharps waste. The size of the container makes it ideal for the safe disposal of medical waste in a private site of use. When mounted with the appropriate bracket, the Travel Savvy Sharps Container can be used for sharps disposal in vehicles. All materials, including sides, bottom, and top are manufactured with Polypropylene plastic. The container is puncture resistant, leak proof on the sides and bottom and stable. Once the lid is closed the device cannot be opened. A mounting bracket is provided for further security. The bracket is designed to secure the sharps container to a fixed location on a vehicle.

The document describes the acceptance criteria and the study conducted for the B Travel Savvy Sharps Container, a single-use device for the disposal of sharps waste.

Here's the information requested:

Acceptance Criteria and Reported Device Performance

Detailed Study Information:

1. Sample sizes used for the test set and data provenance:

   • Needle Penetration Resistance: "All 12 needle puncture force tests" suggests a sample size of 12 for this specific test.
   • Impact and Leak Resistance, Leak Resistance, Sharps Access and Closure, Stability - Spillage, Handling - Transit Damage/Stacking: The document doesn't specify an exact number of samples for each of these tests but refers to "the container," "the sharps container," or "the tested devices" in singular or plural form without quantifiable sample sizes. It mentions using "a new container for each test" in the Stability - Spillage test.
   • Data Provenance: The tests were conducted as "performance bench testing" and "product testing" by Bellegrove Medical Supply, Inc. This indicates it is retrospective data collected internally for the purpose of regulatory submission. The country of origin is not explicitly stated for the testing, but the company is based in the USA.

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

   • Not applicable. This study focuses on physical and mechanical performance characteristics of a sharps container, not diagnostic accuracy requiring expert interpretation. The "ground truth" for these tests is defined by established engineering and safety standards (ASTM, OSHA) and measured objective outcomes (e.g., puncture force, leakage, integrity after drops).

3. Adjudication method for the test set:

   • Not applicable. As with point 2, this type of study does not involve subjective interpretations requiring adjudication. The results are based on objective measurements against defined criteria.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This study is for a physical device (sharps container), not an AI algorithm or a diagnostic tool that involves human readers.

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

   • Not applicable. This is not an AI-based device or an algorithm. It is a physical medical device. The "standalone" concept here would refer to the device's inherent mechanical properties independently tested.

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

   • The "ground truth" or reference standard for these tests is based on recognized consensus standards such as:
     • ASTM F-2131-01 (reapproved 2008) "Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps."
     • OSHA specification (29 CFR 1910.1030) for leak resistance.
     • FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(K)) Submission for Sharps Containers" dated October 1993.
   • The criteria are objective and measurable properties defined by these standards.

7. The sample size for the training set:

   • Not applicable. This is a physical device, and the testing described is performance validation against established standards, not the training of a machine learning model.

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

   • Not applicable, as there is no training set for a machine learning model.

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