(90 days)
The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus. The Antegrade/Retrograde Perfusion Adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.
The Antegrade/Retrogarde Perfusion Adapters are designed to deliver cardioplegia solution to either the coronary sinus or aortic root by the turn of a stopcock and are available with or without a pressure monitoring line. The model with a pressure monitoring line allows for simultaneous monitoring of the coronary sinus pressure while administering cardioplegia solution to either the coronary sinus or aortic root.
In general, a red color-coded tubing with a standard male luer connects to the aortic root cannula's infusion port while a blue color-coded tubing with a standard male luer connects to the coronary sinus cannula's infusion port for delivery of cardioplegia solution. The model provided with a pressure monitoring line is connected to the pressure monitoring outlet of the coronary sinus cannula at one end and the other end is connected to a transducer via a female luerlock connector. An optional male luer-lock swivel adapter is also supplied for this connection. The cardioplegia inlet tubing, which is white color-coded in the pressure monitoring line model, connects to the cardioplegia administration line. The adapter also has a base plate, which allows for either suturing or clamping of the stopcock to the surgical drape.
The provided text is a 510(k) summary for a medical device (Antegrade/Retrograde Perfusion Adapters) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, device performance studies to meet those criteria, sample sizes, expert involvement, or grand truth establishment.
Therefore, most of the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from the provided text.
Here's what can be inferred or explicitly stated based on the given information, with the understanding that many sections will be marked as "Not provided in the text":
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the text. The document refers to "technologic characteristics which are substantially equivalent to the predicate device." This implies performance parity with the predicate, but specific quantifiable acceptance criteria for this device itself are not detailed. | Not provided in the text in terms of specific performance metrics or statistical results. The overarching claim is "substantially equivalent" to the predicate device, meaning its performance is considered comparable for its intended use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided in the text.
- Data Provenance: Not provided in the text.
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 provided in the text. This type of detail is typically associated with clinical performance studies, which are not described here beyond the declaration of substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided in the text.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or referenced in the provided text. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not described or referenced in the provided text. This device is a mechanical adapter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no performance studies requiring ground truth were described. The basis for approval is "substantial equivalence" to a predicate device based on intended use and technological characteristics.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device, and therefore, does not have a "training set" in that context.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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).