(45 days)
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
The MC2 family of cannula, including the new MC2X™ Multi-Stage Venous Cannula, are one piece, wire wound bodies with side ports in the distal tip, with ported atrial basket drainage and with an overall length of 15 ¼". Insertion depth marks aid in positioning the cannula. All are supplied sterile, are non-pyrogenic and are single use. The devices may include a Carmeda® coating.
The provided document is a 510(k) summary for a medical device (MC2XTM Multi-Stage Venous Cannula) and does not contain information typically found in acceptance criteria or a study design for evaluating AI/algorithm performance. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device through design, material, and basic performance testing, rather than a clinical trial or algorithm validation study. Therefore, I cannot extract the requested information regarding acceptance criteria and performance as if it were an AI/algorithm study.
However, I can extract the information related to the device and the types of "performance data" that were considered for its 510(k clearance:
Device: MC2XTM Multi-Stage Venous Cannula
Description of "Study" (Performance Data):
The document states: "Collapse, flow, kink and tensile testing were conducted to ensure proper performance. In addition coverage, bio-activity, leaching and functional testing was performed on Carmeda® coated devices."
This describes physical and material properties testing, not an AI or algorithm performance study.
Here's an attempt to answer using the provided information, while acknowledging the limitations of the document's content with respect to your specific request about AI/algorithm studies:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Adequate collapse resistance | Collapse testing conducted to ensure proper performance |
| Adequate flow characteristics | Flow testing conducted to ensure proper performance |
| Adequate kink resistance | Kink testing conducted to ensure proper performance |
| Adequate tensile strength | Tensile testing conducted to ensure proper performance |
| Appropriate Carmeda® coating coverage | Coverage testing performed on Carmeda® coated devices |
| Appropriate Carmeda® bio-activity | Bio-activity testing performed on Carmeda® coated devices |
| Acceptable Carmeda® leaching levels | Leaching testing performed on Carmeda® coated devices |
| Appropriate Carmeda® functional performance | Functional testing performed on Carmeda® coated devices |
| Substantial equivalence to predicate devices based on design and indications for use | Medtronic Perfusion Systems has demonstrated that the modified MC2X Multi-Stage Venous Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to various types of "testing" but does not detail sample sizes for any of these tests (collapse, flow, kink, tensile, coverage, bio-activity, leaching, functional).
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given the nature of the testing (physical and material performance), it would typically be prospective laboratory testing.
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 is not applicable to the provided document. The "ground truth" for the device's performance is established through engineering and material science testing, not expert consensus on medical images or patient outcomes. There is no mention of experts establishing a ground truth in the context of clinical evaluation or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" are relevant for clinical studies or reviews where multiple experts interpret data (e.g., medical images). The described "testing" is physical and material performance, which would typically involve objective measurements against specifications, not expert adjudication.
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 document describes a traditional medical device (cannula) and its 510(k) clearance based on demonstrating substantial equivalence to predicate devices through engineering and material testing. It does not involve any AI or algorithmic component, nor is it a multi-reader, multi-case clinical study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm or AI component in this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications and established test methodologies for assessing physical properties (collapse, flow, kink, tensile strength) and material properties (coverage, bio-activity, leaching, function for coated devices). These are typically defined standards or internal benchmarks for successful device operation.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or AI component.
§ 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).