(85 days)
The Jostra Retrograde Cardioplegia Cannulas are designed to infuse blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus during cardiopulmonary bypass up to 6 hours or less.
The Jostra Retrograde Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia arrest solution retrograde via the coronary sinus during extracorporeal circulation. The cannulas are made from polyvinyl chloride (PVC) in size 14 Fr. with a variety of balloons, with or without pressure monitoring lines and a choice of stiff or flexible stylets.
The provided text describes a 510(k) summary for the Jostra Retrograde Cardioplegia Cannula, which is a medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance metrics typical of a novel AI device.
Therefore, many of the requested categories for AI/algorithm-based studies (like expert consensus, sample sizes for training/test sets, MRMC studies, ground truth establishment methods) are not applicable to this type of device submission. The acceptance criteria here are based on standard engineering and biocompatibility tests to show the device functions safely and effectively, similar to the predicate.
Here's the information that can be extracted and a clear indication of what is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are not harmful to biological systems. | "Biocompatibility... was performed to demonstrate substantial equivalency to the predicate device." (Implies successful testing without specific metrics) |
| Flow-Pressure curves: Device maintains appropriate flow and pressure characteristics. | "Performance testing included: Flow-Pressure curves" (Implies satisfactory performance, no specific values reported) |
| Kink Resistance: Device resists kinking during use to ensure uninterrupted flow. | "Performance testing included: Kink Resistance" (Implies satisfactory performance, no specific values reported) |
| Bond Strength: Components of the device are securely attached. | "Performance testing included: Bond Strength" (Implies satisfactory performance, no specific values reported) |
| Leakage Test: Device maintains integrity and does not leak. | "Performance testing included: Leakage Test" (Implies satisfactory performance, no specific values reported) |
| Effects on Cellular Components: Device does not adversely affect cellular components during use. | "Additionally, in-vitro testing was performed to determine the effects on cellular components." (Implies no adverse effects, no specific metrics reported) |
| Substantial Equivalence: Device performs as safely and effectively as the predicate device. | "Performance, and in-vitro testing demonstrate that the Jostra Retrograde Cardioplegia Cannulae are 'substantially equivalent' to the predicate devices in intended use, principles of operation, materials, design, and performance." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to device engineering and material performance rather than a clinical "test set" of patient data.
- Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical, likely performed in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) is not relevant for this engineering-focused device submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC study was not done. This type of study is typically for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. This device is a surgical cannula, not a diagnostic tool that involves human interpretation of results.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device itself is "standalone" in that it performs its intended function without requiring an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established by validated engineering standards, specifications, and test methods (e.g., known flow rates, material strength properties, biological compatibility standards). This is implicitly assumed rather than explicitly stated.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use a "training set" in the sense of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 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).