(34 days)
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.
Bio-Medicus™ Insertion Kits contains the necessary components to achieve insertion of a Bio-Medicus™ cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.
The provided text describes a 510(k) premarket notification for the Medtronic Bio-Medicus Insertion Kit. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria for a new device's performance in a clinical setting. Therefore, many of the requested categories for AI/device performance studies (like sample size for test sets, expert qualifications, MRMC studies, training set details, etc.) are not applicable to this type of submission.
However, I can extract the information related to the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "device must achieve X% accuracy"). Instead, the performance evaluation for this submission is based on verifying that the modified components of the Bio-Medicus Insertion Kit function as intended and are comparable to the predicate device. The "acceptance criteria" can be inferred as "Pass" meaning the component performed acceptably according to the test.
| Component | Verification/Validation Test | Performance (Implied Acceptance) |
|---|---|---|
| Dilator | Follows Guidewire | Pass |
| Dilator / Guidewire | Kink Test | Pass |
| Dilator Luer | Body Separation 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)
- Sample Size: Not specified in the provided text. The document refers to "Testing has demonstrated..." but does not detail the number of units tested.
- Data Provenance: Not specified. This would typically be internal laboratory testing (prospective), but no specific location or retrospective/prospective nature is stated.
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 applicable. This is a medical device submission focused on physical properties and functionality, not diagnostic interpretation or clinical outcome assessed by experts in the context of ground truth establishment for an AI/diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for establishing ground truth from expert consensus in diagnostic studies, which is not the nature of this submission. The "Pass" results imply a pre-defined standard or threshold was met during the testing.
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. This is not an AI-powered device, nor is it a diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (insertion kit), not an algorithm. The device "performance" is its mechanical function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" here is the expected physical performance and integrity of the components as measured by standard engineering and device testing methods. The "Pass" indicates that the tested component met the predetermined specifications or performance characteristics defined for that test. This would be based on engineering specifications and perhaps comparison to the predicate device, although the specific criteria are not detailed beyond the test name.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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).