(68 days)
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
These coronary Cannulae consist of basket-style tip, soft (silicone) tip, or spherical tip which is attached to a malleable stainless steel tube, or a soft bulb beveled tip with an integral silicone body. The Cannulae terminate with a locking female luer fitting. The French diameter is measured at the base of the tip adjacent to the sealing flange or across the diameter for the soft bulb beveled tip style. The Cannulae are nonpyrogenic, single use, and sterile.
The provided text describes a 510(k) summary for the Medtronic DLP® Coronary Ostial Perfusion Cannulae, focusing on its substantial equivalence to predicate devices rather than a study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies, as typically found for AI/ML medical devices, is not present in this document. This document pertains to a medical device where the primary evaluation is based on material and design changes compared to a previously cleared device.
However, I can extract the closest analogous information available, interpreting "acceptance criteria" as performance tests to demonstrate substantial equivalence following modifications.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (Results) |
|---|---|
| Burst strength relative to predicate material | Pass |
| Tip component tested for tensile pull-off force | Pass |
| Biocompatibility Assessment (for organic to synthetic barium sulfate change) | Pass - no impact to biocompatibility |
| Hub tested for Tensile Pull-Off Force and Torsional Twist-Off Force | Pass |
| Biocompatibility Assessment (for polypropylene material change) | Pass - no impact to biocompatibility |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the verification and validation tests. The data provenance is implied to be internal testing conducted by Medtronic, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document is for a physical medical device and its predicate equivalence, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies involving human readers, which this submission does not describe.
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
Not applicable. No MRMC study was conducted or described, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on engineering and material science performance standards and specifications, as demonstrated by the "Pass" results in the table. For biocompatibility, it refers to industry-standard assessments that show "no impact."
8. The sample size for the training set
Not applicable. There is no AI/ML model necessitating a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model necessitating a training set or its associated ground truth establishment.
§ 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).