(124 days)
The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.
The Stöckert Electrical Venous Occluder is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the S5 heart lung machine console. It consists of an Occluder Unit and Control Unit to provide
The provided text states that "Design verification and validation information provided in this Special 510(k): Device Modification demonstrates that the product meets prospectively defined design and performance specifications." However, it does not explicitly list the acceptance criteria or the specific studies conducted to prove that the device meets these criteria. Therefore, I cannot generate the requested table or answer most of the questions directly.
Based on the available information, here's what can be provided:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The filing states that the device "meets prospectively defined design and performance specifications" but does not detail what those specifications or the corresponding performance outcomes were.
2. Sample size used for the test set and the data provenance:
This information is not explicitly provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not explicitly provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not explicitly provided in the document.
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 information is not applicable as the device is a "Heart Lung Machine" and an "Electrical Venous Occluder," not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a "Heart Lung Machine" and an "Electrical Venous Occluder," not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly provided in the document. Given the nature of medical device verification and validation for a heart-lung machine accessory, the "ground truth" would likely be based on engineering specifications, physiological parameters, and safety standards rather than expert consensus on image interpretation or pathology.
8. The sample size for the training set:
This information is not explicitly provided in the document.
9. How the ground truth for the training set was established:
This information is not explicitly provided in the document.
§ 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).