(44 days)
The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, singleuse, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).
The Drainage Cannula Kit includes the following accessories:
QTY Kit Component
1 Drainage (Venous) Cannula Body
1 Connector, 3/8-inch, barbed
1 Apical Sewing Ring with Umbilical Tape
1 Apical Sewing Ring Handle
1 Cap (with Umbilical Tape)
1 Apical Support Cuff
4 Suture Rings (large)
4 Suture Rings (medium)
This document is a 510(k) premarket notification for a medical device, specifically the Thoratec CentriMag Drainage (Venous) Cannula Kit. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" against which specific numerical performance metrics are compared. Instead, it lists various "performance and functional verification tests" that were successfully conducted. The implicit acceptance criterion for each test is "successful results," indicating compliance with the design requirements for that particular test.
| Acceptance Criteria (Implicit: "Successful Results") | Reported Device Performance |
|---|---|
| Flex Test | Successful |
| Tensile Strength Test | Successful |
| Chemical Resistance Test | Successful |
| Pressure Test | Successful |
| Suture Ring and Apical Sewing Ring Security and Deformation Test | Successful |
| Dimensional Verification Examination | Successful |
| Cannula Body Material Examination | Successful |
| Chemical Characterization (of materials) | Successful |
| Biocompatibility (of materials) | Successful |
| Microbiological Performance Qualification (revalidation) | Successful |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the test set for any of the listed performance tests. It also does not explicitly state the data provenance (country of origin, retrospective/prospective). However, the general context of a 510(k) submission typically implies that such testing is conducted by the device manufacturer (Thoratec Corporation, based in Pleasanton, CA) as part of their design verification and validation process, which would be prospective for the purpose of the submission.
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):
This information is not provided in the document. The performance tests described (Flex, Tensile Strength, Chemical Resistance, etc.) are typically engineering and material science tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes. Therefore, "ground truth" in this context would likely be established by engineering specifications and objective measurements, rather than expert consensus in a medical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the types of performance tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. The tests mentioned are objective engineering and material tests.
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, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (a cannula kit), not an AI-powered diagnostic or assistive tool. Clinical testing was explicitly stated as "not performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical medical device (cannula kit), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests listed would be based on engineering specifications, material science standards, and predefined acceptance limits for each test (e.g., a specific tensile strength value, a certain pressure resistance, dimensional tolerances, chemical inertness). It is not based on expert consensus, pathology, or outcomes data, as these are non-clinical (bench and material) tests.
8. The sample size for the training set:
This information is not applicable. The document describes a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" for this type of device.
In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a cannula kit) through non-clinical performance and functional verification tests. It does not involve AI development, clinical trials, or expert-based ground truth establishment in the way typically seen for diagnostic algorithms.
§ 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).