(74 days)
The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:
A) One Obturator (or Introducer)
B) One Hemostasis Seal
C) One Cap
D) One Porous Plug
E) One Needle with Sheath
F) One Guidewire Assembly
G) Two Stabilizer Rings Medium
H) Two Stabilizer Rings Small
I) Two Tip Stabilizers
The provided text describes a medical device, the Levitronix CentriMag Return Cannula Kit, and its 510(k) summary for FDA clearance. However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional testing, not through AI/ML performance metrics.
Therefore, for aspects related to AI/ML studies, ground truth, sample sizes for training/test sets, expert adjudication, or MRMC studies, the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be extracted based on the provided text, primarily regarding the device's functional performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that functional testing was performed and "All met pre-established acceptance criteria." However, the specific acceptance criteria and the quantified reported device performance values are not provided in the text. It only lists the categories of tests performed.
| Acceptance Criteria (Category) | Reported Device Performance (Summary) |
|---|---|
| Physical Testing | Met pre-established acceptance criteria |
| Sterilization Validation | Met pre-established acceptance criteria |
| Biocompatibility | Met pre-established acceptance criteria |
| Shelf Life Studies | Met pre-established acceptance criteria |
| Transportation | Met pre-established acceptance criteria |
| Hemolysis (in vitro) | Met pre-established acceptance criteria |
| Flow versus Pressure Drop | Met pre-established acceptance criteria |
The following questions cannot be answered from the provided text, as they pertain to AI/ML performance studies, which were not conducted for this device clearance.
2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The device is a physical medical device (cannula kit), and its clearance relied on functional and bench testing, not an AI/ML model evaluated on a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. No ground truth for a test set was established as there was no AI/ML model being evaluated.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable / Not provided. No test set or expert adjudication for an AI/ML model was involved.
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 / Not provided. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. Ground truth, in the context of AI/ML, was not established for this device. The "truth" for this device's performance was determined by established engineering specifications and biological safety standards (e.g., for hemolysis, biocompatibility).
8. The Sample Size for the Training Set
- Not applicable / Not provided. There was no AI/ML model needing a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. There was no AI/ML model or training set with associated ground truth.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).