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510(k) Data Aggregation
(52 days)
Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of
Edwards venous cannulae are polymeric tubes intended to provide a means of returning deoxygenated blood from a patient to the oxygenator during cardiopulmonary bypass procedures. The cannulae are available in a range of sizes and types and in a variety of tip and hole configurations. Variants include codes with ½" to ¼" acceptance or connectors. Cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:
While the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, it does not contain explicit "acceptance criteria" in the format of specific thresholds for a device's performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for an AI/ML medical device. Instead, it discusses functional and safety testing to show comparable performance to a predicate device.
Given that limitation, I've interpreted "acceptance criteria" as the criteria for demonstrating substantial equivalence and "reported device performance" as the overall conclusion from the functional/safety testing.
Description of Acceptance Criteria and Study
The Edwards Lifesciences Venous Cannula, as described in this 510(k) summary, underwent a comparative analysis study to demonstrate substantial equivalence to its predicate device. This study focused on functional and safety performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Functional Equivalence: The proposed devices must perform in a substantially equivalent manner to the predicate device regarding intended use, fundamental scientific technology, material type, principles of operation, and functional performance. | "The functional data indicate that the proposed devices perform in a substantially equivalent manner when compared with the predicate device." |
| Safety Equivalence: The device must demonstrate comparable safety performance to the predicate device. | (Implied by the overall conclusion of substantial equivalence in conjunction with functional data, although not explicitly stated as separate "safety data" findings in the summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described appears to be laboratory-based functional and safety testing rather than a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. Functional and safety testing of a physical medical device typically involves engineering and quality assurance personnel, rather than clinical experts establishing a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a process requiring expert adjudication for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially AI/ML-based ones) to assess the impact of a device on human reader performance. The device described is a physical venous cannula.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance assessment was not done. This concept is only relevant for AI/ML algorithms. The device is a physical medical device.
7. The Type of Ground Truth Used
Given the nature of the device (a physical venous cannula) and the testing described (functional/safety), the "ground truth" would be established by engineering specifications, material science standards, and established performance criteria for such medical devices. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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