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The Quiver Aspiration Pump is intended for general suction use in hospitals or clinics.

The Quiver Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Quiver Aspiration Pump provides battery powered suction for the removal or aspiration of fluids and debris. The Pump is a portable, single-use, non-sterile and provides up to -29inHg vacuum pressure. For sterile field use, the pump is provided with sterile accessory tubing and a sterile flow control switch. The accessories are also single-use and disposable. The Quiver Aspiration Pump system is comprised of the following:

• Quiver Aspiration Pump: The Quiver Aspiration Pump is battery-operated (18VDC, nonrechargeable), has an ON/OFF button, and serves as a vacuum source for aspirating and suctioning for general use applications. Within the pump assembly, the DC motor drives a diaphragm pump that provides high vacuum suction and flows in one direction for material removal only. Affixed to the pump is a waste collection bag (500mL) that collects and contains all fluids and materials that were aspirated. The aspiration pump is non-patient contacting. Sterile aspiration tubing accessories are provided with the pump to facilitate connection to other suction devices with a standard medical luer connection. The inline flow control switch allows the user to initiate and terminate the suction from the distal end of the tubing. The entire pump assembly is disposable following standard biohazard handling procedures.
• Accessories: Included in the pump package are the aspiration tubing and the inline control flow switch. Both accessories are individually packaged in sterile pouches. These components are finished sterile devices manufactured and sterilized by Merit Medical (South Jordan, UT) and sold to Anoxia as finished medical devices. The aspiration tubing has a standard female luer fitting. The inline flow control switch is connected to the distal end of the tubing. The tubing is 72 inches long to allow for use within a sterile field if necessary for general suction applications. The flow switch has a standard male luer that can be connected to other devices used for suction that have the same standard medical luer. The two accessories and the pump are packaged in a carton box.

The provided text focuses on the 510(k) submission for the Quiver Aspiration Pump and its substantial equivalence to a predicate device. It details product description, intended use, and a list of performance tests conducted.

However, the text does not contain the specific acceptance criteria for these tests, nor does it provide the detailed results or a study report that definitively "proves" the device meets those criteria. It only states that comparative testing yielded "substantially similar results" and that "performance testing was completed to demonstrate safety and effectiveness."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not present in the provided document.

The document discusses the following performance data but lacks the specific details requested:

• Performance Data Listed:
  • Visual Inspection Test
  • Leak and Vacuum Test (Air)
  • Max Vacuum Test (Water)
  • Simulated Use Test
  • Tensile Strength Test
  • System Comparative Test
  • Packaging and Shelf-Life Test
  • Electrical Safety and EMC Testing

Key observations regarding your specific questions based on the provided text:

1. Table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging devices, not typically for aspiration pumps.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of device performance testing for an aspiration pump. Performance is typically measured against engineering specifications and validated methods.
8. The sample size for the training set: Not applicable and not mentioned, as this is not a machine learning/AI device with a "training set."
9. How the ground truth for the training set was established: Not applicable.

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