(162 days)
These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
The Three Stage Venous Return Cannula consists of a single tube body with a 3/8" flared end to allow for connection to the bypass circuit. These cannulae have three open areas for venous drainage. An obturator is included. Its purpose is to decrease blood loss during insertion depth markers are printed on each cannula and aid in positioning the cannula.
The provided text describes a 510(k) submission for a medical device, the "Three Stage Venous Return Cannula." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information you're requesting regarding acceptance criteria, study details, and specific metrics like AI improvement effect size or standalone algorithm performance, is largely not applicable to this document.
However, I can extract the information that is present regarding performance evaluation and how the device meets "acceptance criteria" in the context of a 510(k).
Here's a breakdown based on your request, with clarifications on why certain sections are not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of specific, quantified acceptance criteria with corresponding numerical performance results. Instead, it lists types of performance evaluations conducted to demonstrate substantial equivalence to a predicate device. The "performance" is implicitly that the device performs "as intended" and is "substantially equivalent."
| Acceptance Criteria Category (Implicit) | Reported Device Performance |
|---|---|
| Functional & Mechanical Performance | |
| Connector attachment | Performed as intended, substantially equivalent to predicate. |
| Clamp test | Performed as intended, substantially equivalent to predicate. |
| Obturator Seal Test | Performed as intended, substantially equivalent to predicate. |
| Kink test | Performed as intended, substantially equivalent to predicate. |
| Collapse test | Performed as intended, substantially equivalent to predicate. |
| Tensile test | Performed as intended, substantially equivalent to predicate. |
| Hemodynamic Performance | |
| Flow Testing | Modified device includes a third basket to maintain comparable flow characteristics to the dual stage venous return cannulae. Performed as intended, substantially equivalent to predicate. |
| Simulated Use | |
| Simulated use test | Performed as intended, substantially equivalent to predicate. |
| Overall Equivalence | |
| Intent (Use, Principles, Technology, Design, Materials, and Performance) | Substantially equivalent to predicate. Differences do not raise new safety/effectiveness issues. |
2. Sample sizes 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 in the provided document. The performance evaluations are listed, but the number of units tested for each evaluation is not detailed.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a device like this, these would typically be in-house engineering and bench tests, not clinical studies with patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a 510(k) submission of this type, which involves bench and simulated use testing of a physical medical device, "ground truth" is established through engineering specifications, validated test methods, and comparison to the predicate device's known performance characteristics. There is no mention of "experts" in the context of establishing ground truth in the way one would for diagnostic imaging or AI algorithms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert consensus panels, often for image interpretation or diagnosis. This document pertains to performance evaluations of a physical medical device.
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 a conventional medical device (venous cannula) and does not involve AI or human readers. Therefore, an MRMC study or AI assistance effect size is irrelevant.
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 a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluations listed would be based on:
- Engineering specifications and standards: For characteristics like connector attachment strength, kink resistance, tensile strength, and collapse pressure.
- Predicate device performance: The performance of the predicate Dual Stage Venous Return Cannula served as the benchmark for "substantially equivalent" performance.
- Biocompatibility principles: While not explicitly detailed as "ground truth," the materials used (implicitly similar to the predicate) would be expected to meet biocompatibility standards.
8. The sample size for the training set
Not applicable. This document describes a physical medical device undergoing performance evaluation for a 510(k) submission, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).