Search Results

Quantum Perfusion Dual Lumen Cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

All medical devices pertaining to Quantum Perfusion Dual Lumen Cannula product family are single use devices intended to be used in medical procedures providing cardiac and/or respiratory support up to 6 hours. Devices are characterized by two coaxial catheters and are designed to be coupled with an extracorporeal circuit for artificial oxygenation of the blood and carbon dioxide removal.

Devices exploit a single site insertion which reduces the invasiveness of extracorporeal procedures. It can be inserted via a percutaneous approach through the right internal jugular vein. Blood is drained through the lumen of the outer catheter and returned through the lumen of the inner catheter.

Devices feature multiple inflow openings in the outer catheter limiting the circulation of unoxygenated blood.

Devices are non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a double pouch. All the devices' surfaces in contact with blood are coated with a phosphorylcholinebased biocompatible material.

The provided text describes a 510(k) premarket notification for Qura's Quantum Perfusion Dual Lumen Cannula, which introduces new REF codes (different sizes) and a warning in the Instruction for Use. It does not describe acceptance criteria for an AI/ML powered device or a study involving human readers or sophisticated ground truth establishment.

Therefore, most of the requested information (related to AI/ML device performance, reader studies, type of ground truth, training sets, etc.) cannot be extracted from this document, as it pertains to a medical device's physical and mechanical performance rather than an AI/ML algorithm.

However, I can extract the relevant information regarding the non-clinical testing for this specific medical device submission.

Here's what can be extracted based on the provided text:

Study and Acceptance Criteria Information (as per the provided document's scope):

The document describes the performance data and conclusions for new variants of a Quantum Perfusion Dual Lumen Cannula. The "study" here refers to the non-clinical bench testing conducted to demonstrate product safety and effectiveness for these new variants.

1. A table of acceptance criteria and the reported device performance:

The document mentions "Performance tests for new REF codes introduced in the portfolio, according to applicable Recognized Consensus Standard ISO 18193:2021" specifically, "Evaluation of devices' Pressure Drop." However, the specific acceptance criteria values (e.g., "Pressure drop must be less than X mmHg at Y flow rate") and the reported device performance values are not detailed in this summary. It only states that testing was performed "as per same internal applicable standards/protocols applied for predicate devices (K203067)."

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

• Sample Size for Test Set: Not specified. The document states "Performance tests for new REF codes introduced in the portfolio..." but does not mention the number of devices tested.
• Data Provenance: The tests were conducted by Qura S.r.l. in Italy, as indicated by the submitter's address. The data is likely from retrospective (bench testing) as opposed to clinical (patient) studies, given the "Non-Clinical Testing" section.

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

This is not applicable as the "ground truth" for a physical medical device like a cannula is established through engineering specifications, material properties, and physical performance testing against recognized standards (like ISO 18193:2021). There are no "experts" in the sense of human readers/interpreters establishing ground truth for image analysis or diagnostic tasks.

4. Adjudication method for the test set:

This is not applicable. Adjudication typically refers to resolving discrepancies between human readers or between human and AI interpretations in diagnostic or imaging studies. For physical device performance testing, results are typically objective measurements against engineering specifications.

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:

This is not applicable. This document is for a physical medical device (cannula), not an AI/ML-powered diagnostic or assistive device. No MRMC study was conducted or is relevant for this type of submission.

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

This is not applicable. This describes a physical medical device, not an AI algorithm.

7. The type of ground truth used:

The ground truth for this medical device is based on engineering specifications and performance standards (specifically ISO 18193:2021) for characteristics like "Pressure Drop," as well as material properties and structural integrity.

8. The sample size for the training set:

This is not applicable. This is not an AI/ML model, so there is no "training set."

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

This is not applicable.

Ask a specific question about this device