(29 days)
These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.
The One Piece Pediatric Arterial Cannula Models 77006 and 77106 are 6 Fr., flexible, thin-walled cannula with wire wound bodies and a 9" overall length. They have a beveled tip that is made as part of the PVC body. There are depth markings located at 1 cm increments. A tip orientation line indicates the direction of the bevel for location once the cannula is inside the body. The proximal end of the cannula terminates in a 1/4" barbed connector that can be either vented or non-vented. The model 77006 is vented and the model 77106 is non-vented. The proximal end connector on these models is also molded as part of the body.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Medtronic Perfusion Systems "One Piece Pediatric Arterial Cannula Models 77006 and 77106":
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance | Study Type |
|---|---|---|---|
| Visual Inspection | Absence of defects | "found acceptable" | In vitro |
| Dimensional Testing | Correct dimensions of cannula and markings | "found acceptable" | In vitro |
| Leak Testing | No water or air leakage | "found acceptable" | In vitro |
| Bend Tests | Acceptable flexibility/durability under various bends | "found acceptable" | In vitro |
| Functional Testing | Acceptable performance in simulated use | "found acceptable" | In vitro |
| Substantial Equivalence | Demonstrates equivalence to predicate devices based on design, test results, and indications for use. | "demonstrated that the Arterial One Piece Pediatric Cannula Models 77006 and 77106 are substantially equivalent to predicate devices based upon design, test results, and indications for use." | Substantial equivalence comparison |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text only mentions "various bend tests" and general "in vitro visual, dimensional, simulated use and functional testing."
- Data Provenance: The "Summary of Performance Data" describes "in vitro" testing. This implies the data was generated in a lab setting, likely without direct human patient involvement or geographical origin listed. It does not indicate retrospective or prospective data from a clinical setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study involved in vitro testing of the device's physical and functional properties, not a diagnostic or AI-based assessment requiring expert ground truth establishment.
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Adjudication method for the test set:
- Not applicable. As noted above, this was an in vitro engineering performance study, not a clinical study or AI performance evaluation requiring adjudication of interpretations. The "acceptance" was likely based on pre-defined engineering specifications and test protocols.
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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 done. This device is a medical cannulae, not an AI-powered diagnostic tool requiring human reader comparisons.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical product, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this study was established by engineering specifications, design requirements, and pre-defined test protocols for the physical and functional characteristics of the cannulae. The "accepted" results indicate that the device met these engineering specifications.
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The sample size for the training set:
- Not applicable. This device is a physical medical product, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there was no AI model or training set.
§ 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).