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510(k) Data Aggregation
(101 days)
The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.
MiARTM Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the aorta in an antegrade manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature two tip sizes and the Flow-Guard™ feature to maintain hemostasis during removal of the introducer needle from the cannula. The increased overall length of these cannulae relative to standard models, make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thoracotomy).
The provided document is a 510(k) summary for the Medtronic MiAR™ Aortic Root Cannula with Flow-Guard™. This is a medical device, and the document focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific diagnostic or therapeutic performance based on complex acceptance criteria and clinical trials, which would be typical for an AI/ML powered device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this type of regulatory submission.
However, I can extract the general acceptance criteria used for this device, which are based on engineering performance characteristics.
Here's a summary of the requested information based on the provided text, indicating where information is not applicable (N/A) due to the nature of the device and submission:
Acceptance Criteria and Device Performance for Medtronic MiAR™ Aortic Root Cannula with Flow-Guard™
The Medtronic MiAR™ Aortic Root Cannula with Flow-Guard™ is a Class II medical device intended for use during cardiopulmonary bypass. The regulatory submission focused on demonstrating substantial equivalence to predicate devices (Medtronic DLP Aortic Root Cannula K790565 and Medtronic Pediatric Aortic Root Cannula K040173) through bench testing. Clinical testing was not required to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance |
|---|---|
| Flow Rate Versus Pressure Drop | Met - Bench testing conducted. (Implicitly, performance was comparable to predicate devices or within acceptable engineering limits as no new issues of safety/effectiveness were raised). |
| Distal Tip Visibility Under Fluoroscopic Visualization | Met - Bench testing conducted. (Implicitly, performance was comparable to predicate devices or within acceptable engineering limits). |
| Structural Integrity (bonded joints) | Met - Bench testing conducted. (Implicitly, performance was comparable to predicate devices or within acceptable engineering limits). |
| Technological Characteristics | Same as predicate devices. |
| Operating Principle | Same as predicate devices. |
| Design Features (excluding length) | Same as predicate devices (only longer length). |
| Flow-Guard™ Introducer | Same as predicate devices. |
| Connectors | Same as predicate devices. |
| Materials | Same as predicate devices. |
| Shelf Life | Same as predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "Bench testing was used," implying a series of laboratory tests. Specific sample sizes for each bench test are not provided in this 510(k) summary.
- Data Provenance: Bench test data. Not applicable for country of origin or retrospective/prospective as it relates to clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert consensus for diagnostic accuracy, is not relevant for this device's performance assessment. Performance was established via engineering bench tests.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical studies, not for objective engineering bench tests.
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. This is not an AI/ML powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Specifications. The "ground truth" for this device's performance would be the pre-defined engineering specifications, material properties, and functional requirements, against which the bench test results were compared.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, this question is not applicable.
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