(70 days)
This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft.
The cannula has a graduated, soft silicone, rubber tip to accommodate vessels of various sizes. The attached 50.8 cm (20 in) flexible tube has a clamp to stop flow through the cannula. Model 10011 has an additional clamp on the antegrade outlet line to stop the flow of fluid into the antegrade cannula. The antegrade cannula connector is a male luer adapter. The cardioplegia inlet fitting is a female luer port. Sterile, nonpyrogenic, single use.
The provided text is a 510(k) Pre-Market Notification for the DLP® Vein Graft Cannula. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical or standalone study with detailed performance metrics.
Therefore, the document does not contain the information required to answer most of your questions, as it is structured differently from what would be presented for a study proving device acceptance criteria in the manner you've outlined.
However, I can extract the limited "performance data" presented and explain why other requested information is not available in this document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of specific thresholds for the performance metrics tested. Instead, it reports "Pass" for the conducted tests, implying that the device met an unstated internal acceptance criterion.
| Test Conducted | Reported Device Performance |
|---|---|
| For Model 10010 (Bonding to male luer) | |
| Air Flow Test | Pass |
| Leak Test | Pass |
| Bond Strength Test | Pass |
| For Model 10010 (Y-Connector changed to in-house manufacturing) | |
| Air flow test | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The 510(k) summary only lists the type of tests performed and the results ("Pass") but does not detail the methodology, sample sizes, or data provenance.
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 applicable and therefore not available. The "ground truth" concept is typically relevant for studies involving subjective interpretation (e.g., image analysis, clinical diagnosis), where expert consensus or pathology is used to validate an AI algorithm's output. The tests described here are engineering/performance verification tests for a physical medical device (cannula), not an AI or diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not available for the same reasons as point 3. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not the nature of the tests performed on this device.
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 and therefore not available. An MRMC study is relevant for evaluating the impact of an AI system on human diagnosticians' performance. The DLP® Vein Graft Cannula is a physical medical device used in surgery, not an AI or diagnostic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not available. The concept of "standalone performance" refers to the performance of an algorithm without human intervention. This device is a physical surgical cannula and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of the device's performance tests. The "ground truth" in this context would be the objective physical properties and functional performance of the cannula as measured against engineering specifications (e.g., bond strength exceeding a certain threshold, no leaks under pressure). The document doesn't detail these specific underlying ground truths or specifications.
8. The sample size for the training set
This information is not applicable and therefore not available. "Training set" refers to data used to train an AI algorithm. The DLP® Vein Graft Cannula is a physical medical device and does not involve an AI algorithm or a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not available for the same reasons as point 8.
§ 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).