Search Results

The A-Med Vascular Cannula is intended for use in accessing the circulatory system during extracorporeal circulation.

The A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system. (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.

The A-Med Vascular Cannula is a cannula comprised of a flexible tip, radiopaque stripes, wire reinforced tubing, non-reinforced proximal clamp zone, and a proximal connector. Configurations are available with the following options:

• . Outer diameter: 24 French
• . Effective length: 10, 21 inch
• Number of holes in tip: 8, 16, 32, 44 (dependant on length) ●
• Proximal connector: barb, barb with side luer lock, quick connect ●

The provided 510(k) premarket submission for the A-Med Systems, Inc. Vascular Cannula (K991541) does not contain acceptance criteria or study details in the requested format for AI/software-as-a-medical-device (SaMD) products.

This submission is for a physical medical device (a vascular cannula) and follows the regulatory pathway for such devices, primarily relying on non-clinical performance testing and substantial equivalence to a predicate device.

Therefore, many of the requested fields are not applicable to this submission. I will address the applicable parts based on the provided text, and explicitly state when a requested piece of information is not available or not relevant to this type of device submission.

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable in the context of SaMD. For this physical device, the "test set" refers to the specific cannulas and materials used in the non-clinical performance tests (e.g., mechanical strength, flow rates, material compatibility). The document does not specify the number of units tested.
• Data Provenance: The tests were conducted internally by A-Med Systems, Inc. (implied by "A-Med Systems, Inc. performance specifications"). The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's address. The data is "prospective" in the sense that the tests were performed specifically for this submission, not a retrospective analysis of existing data.

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

• Not Applicable. For a physical device like a vascular cannula, "ground truth" in the SaMD sense (e.g., expert consensus on image interpretation) is not established. Performance is measured directly (e.g., flow rates, material properties, mechanical integrity) against specifications validated by engineering and regulatory standards. The expertise involved would be in engineering, material science, and quality assurance, rather than clinical interpretation.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in studies involving subjective assessments (e.g., radiology reads). This is not relevant for the non-clinical performance testing of a physical device.

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

• No. This is a physical medical device, not an AI/software device designed to assist human readers. Therefore, an MRMC study is not relevant or applicable.

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

• No. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the SaMD context is not applicable.

7. The type of ground truth used

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this device's performance is established by:
  • Comparison to the performance characteristics of the legally marketed predicate device (Baxter/RMI FEM FLEX II Cannula).
  • Adherence to internal A-Med Systems, Inc. performance specifications, which would be derived from engineering requirements, material standards, and clinical needs for such a device.
  • This is not "expert consensus," "pathology," or "outcomes data" in the typical SaMD sense.

8. The sample size for the training set

• Not Applicable. This is a physical device, not a machine learning algorithm. There is no concept of a "training set" for manufacturing and testing a vascular cannula for regulatory submission in this context.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device