Search Results

Techen Safety Sharps Disposal Containers with Screw Top Caps are intended for single use disposal of used or contaminated medical sharps, including but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in a variety of healthcare settings. They are suitable for physicians offices, dental offices, laboratories, home health, patient room, and other generation of medical waste.

The Sekurit Sharps Collection Container is a single piece container which is blow molded of High Density Polyethylene plastic and is available in 1 Gallon, 3 Gallon, 3 Gallon and 1.4 quart sizes. Each container is of the same design type and altered only in its height to achieve the needed capacities. The containers are available in translucent red and yellow colors as well as . opaque red and yellow colors. Sekurit Sharps Collection Containers have a threaded screw neck and utilize a puncture resistant screw cap molded from Polypropylene. These containers are NOT reusable.

The provided text focuses on the K063722 510(k) submission for "Sekurit Sharps Collection Containers," which are physical medical devices, not AI/ML-driven software. Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available within this document. The document primarily concerns the regulatory clearance of a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific acceptance criteria or performance metrics in a quantitative manner as would be expected for an AI/ML device. For physical devices like sharps containers, "performance" relates to their physical integrity and ability to safely contain sharps. The 510(k) summary states that the device is "substantially equivalent" to predicate devices, implying it meets the same implicit safety and performance standards.

The primary "acceptance criteria" for this type of device would generally involve meeting certain standards for puncture resistance, leakage prevention, and safe closure, which are usually tested against established industry or regulatory standards (e.g., OSHA guidelines, ISO standards). However, these specific criteria and their measured performance are not explicitly detailed in the provided text.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical sharps container, not an AI/ML device processing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is not relevant for this physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This is a physical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

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

Ask a specific question about this device